Provider review
Marek Health Review: Seven Named Pharmacies, and a Peptide Catalogue Nobody Can Open
Marek Health does the disclosure almost nobody does: its terms of service name seven pharmacies, each with a street address, a phone number and an email, and tell you your prescription may be transferred between any of them. It then sells "physician-prescribed TRT, GLPs, and therapeutic peptides" across a live site that names not one peptide molecule. The molecules exist. Thirteen of them — BPC-157, TB-500, CJC-1295, ipamorelin, MOTS-c, selank, semax, GHK-Cu, sermorelin, tesamorelin, somatropin, SS-31 and thymosin alpha-1 — sit in a 112-treatment catalogue that is downloaded into every visitor's browser as a JavaScript file and rendered on no page at all. Eight of the thirteen are named on FDA's published list of bulk substances that may present significant safety risks. The catalogue's own copy for BPC-157 says "No completed human clinical trials; all evidence is preclinical", which is the most honest sentence in the category and is currently visible to nobody.
Compounded only
Phase 3 trials
Named
None found
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Opens marekhealth.com. A link is not a recommendation to take anything.
Provenance
What Marek Health actually dispenses
Regulatory category is the axis consumers are most reliably misled about, so it comes first. Every product below is sorted by what it legally is, not by what it costs.
Prepared by a state-licensed pharmacy against a prescription for a named patient. Compounded preparations are not FDA-approved and are not reviewed by FDA for safety, effectiveness or quality.
- Guided Optimization® peptide therapy — The entry point is published and the medication price is not. The home page states $299 for the intake assessment and "minimum $450 lab panel purchase required"; the unreleased catalogue's own FAQ repeats "Pricing starts with a $299 intake assessment… Lab pricing starts at $450. If your provider determines a prescription is appropriate, medication cost is separate and varies by dose." No figure for any medication appears anywhere on the site.
- BPC-157 (injectable vial, oral capsule, nasal spray, BPC-157 + KPV combination capsule)
- Tesamorelin injectable (subcutaneous) vial
- SS-31 (Elamipretide) injectable vial, and a combination vial with L-carnitine
- CJC-1295 + Ipamorelin injectable (subcutaneous) vial
Evidence
Is there a human trial at all?
One row per product, graded on how far the published human evidence goes for the use it is sold for — not for the molecule in general. A molecule with phase 3 evidence for one outcome has none for another, and that distinction is where peptide marketing lives.
4
Products with a human trial
Out of 5 reviewed here.
10
Registry records cited
Each read live from ClinicalTrials.gov, never from memory.
The comparison
What they claim, against what the trials show
Each claim below is quoted verbatim from Marek Health’s own page, with the page it came from. Grading a paraphrase would prove nothing. Every row is the verdict at a glance — tap it to open the quote, the trial registry entries, and the full note behind that verdict.
Guided Optimization® peptide therapyNot named on any reachable page — sold as "therapeutic peptides" · Compounded (503A)No trial supports this claim
“Guided Optimization® is a clinically supervised program featuring physician-prescribed TRT, GLPs, and therapeutic peptides to optimize hormones, body composition, energy, and performance.”
No human trial
No registry record can be matched to this claim, because the live site attaches no molecule to it. As of 9 August 2026, every page in the four published sitemaps was requested and all 186 JavaScript chunks referenced by the build manifest were downloaded (5.1 MB). Across the pages a reader can actually reach — the home page, /telehealth, /trt, /testosterone, /weight-loss, /performance, /sexual-health, /faqs and the legal pages — the words "peptide" and "peptides" appear only as a category: "therapeutic peptides", "GLP-1s, peptides, TRT", "600+ medications, peptides & supplements". Not one peptide molecule is named on any of them. The names are in the bundle and on no page: /_next/static/chunks/8961-d221c81a8bb1a91c.js carries 112 treatment records including thirteen peptides, and every route that would render them (/v3/treatments/[slug]) resolves to the home page.
"To optimize hormones, body composition, energy, and performance" is four outcome claims in one clause, with no molecule attached to any of them. That is the structural problem, not a rhetorical one: an unnamed drug cannot be looked up, cannot be checked against a trial, cannot be checked for interactions, and cannot be checked against FDA's list of bulk substances it may not lawfully be compounded from. Marek is unusual in having written the molecule-level detail — it is sitting in the bundle, with dosage forms and state exclusions — and unusual again in publishing none of it where a prospective customer would read it.1,2
BPC-157 (injectable vial, oral capsule, nasal spray, BPC-157 + KPV combination capsule)BPC-157 · Compounded (503A)Claim matches the trials
“Synthetic 15-amino-acid pentadecapeptide derived from gastric juice glycoprotein. Strong tissue-protective and healing properties across multiple organ systems in animal models. No completed human clinical trials; all evidence is preclinical… Accelerated tendon/ligament/muscle repair (animal models). GI cytoprotection and mucosal healing. Anti-inflammatory without immunosuppression. Works systemically via multiple routes.”
Phase 1 only
- NCT02637284 — Phase 1, unknown status, n=42. Sponsor PharmaCotherapia d.o.o. "Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157." Enrolment 42 ESTIMATED — the registry carries no actual figure. Listed completion March 2016; overall status has read UNKNOWN ever since and no results have been posted.
- NCT07437547 BPC-HAMSTR — Phase 2, recruiting, n=120. Sponsor Hudson Biotech. "A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain Confirmed by MRI." Started 2 February 2026, estimated completion 17 February 2028, target 120. It is recruiting and has reported nothing.
This is the rarest verdict on this site and it is earned. "No completed human clinical trials; all evidence is preclinical" is exactly what the record shows: a PubMed search restricted to the randomised-controlled-trial publication type returns zero records for BPC-157, and the two registered studies are a phase 1 pilot whose status has read UNKNOWN since 2016 without posting a result and a phase 2 that began recruiting in February 2026 and will not report before 2028. Marek then labels its own efficacy bullet "(animal models)" and lists "No completed human safety trials" under serious risks. Two things it does not say. It does not say that FDA names BPC-157 on its published page of bulk drug substances that may present significant safety risks, stating that compounded drugs containing it "may pose risk for immunogenicity for certain routes of administration" — which bears directly on the four dosage forms offered, one of them a nasal spray and one an oral capsule that no registered study has tested. And it does not say any of this anywhere a customer can read it.1,3,4,5
Tesamorelin injectable (subcutaneous) vialTesamorelin · Compounded (503A)Claim reaches past the trials
“Full 44-amino-acid GHRH analog with enhanced stability. Only GHRH analog with current FDA approval (HIV lipodystrophy). Promising cognitive benefit data from The Lancet Healthy Longevity… Significant VAT reduction (~15 to 18%). FDA-approved with Phase III data. Promising cognitive benefits in aging… Tesamorelin in HIV-Infected Patients with Abdominal Fat — New England Journal of Medicine (2010): Phase 3 (n=412): 15.2% VAT reduction vs -0.5% placebo at 26 weeks… Tesamorelin and Cognition in Older Adults — The Lancet Healthy Longevity (2021): Improved verbal memory and executive function over 20 weeks in older adults including those with MCI.”
Phase 3 trials
- NCT00123253 — Phase 3, completed, n=412. Sponsor Theratechnologies. "A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507… in HIV Patients With Excess of Abdominal Fat Accumulation." Conditions: HIV infections, lipodystrophy. Ran June 2005 to April 2007.
- NCT00675506 — Phase 2, completed, n=60. Massachusetts General Hospital, "Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity" — the only registered study of this molecule in abdominal obesity outside HIV. Completed January 2012, enrolment 60 actual.
The molecule is real, the approval is real, and both of the citations printed under it are wrong in ways a reader could catch. The 412-patient phase 3 that reported a 15.2% fall in visceral adipose tissue was published in the New England Journal of Medicine in 2007, not 2010, and the placebo arm did not fall 0.5% — it ROSE 5.0%. Halving the effect size in the wrong direction is an unusual error to find on a marketing page. The second card cites "The Lancet Healthy Longevity (2021)"; a PubMed search of that journal for tesamorelin or growth-hormone-releasing hormone returns zero records. The trial actually described — 20 weeks, verbal memory and executive function, adults with MCI and healthy older adults — is Baker et al., Archives of Neurology, 2012. Underneath the citations, the same swap this category always makes: the approved product's label reads "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy", and under Limitations of Use, "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect." Marek lists "Visceral adiposity / metabolic syndrome (off-label)" as an indication, which is at least labelled off-label — but outside HIV the registry holds one phase 2 study of 60 people that finished in 2012.6,7,8,9,10
SS-31 (Elamipretide) injectable vial, and a combination vial with L-carnitineElamipretide (SS-31) · Compounded (503A)Claim reaches past the trials
“Mitochondria-targeted tetrapeptide that binds cardiolipin in the inner mitochondrial membrane, stabilizing cristae structure and improving electron transport chain efficiency. In Phase II/III for HFpEF and Barth syndrome… Phase II evidence showing improved exercise capacity. Favorable safety in completed trials… Phase III trials ongoing, full safety profile not established.”
Phase 3 trials
- NCT03098797 TAZPOWER — Phase 2/Phase 3, completed, n=12. Stealth BioTherapeutics. Randomised, double-blind, placebo-controlled crossover trial in genetically confirmed Barth syndrome followed by open-label treatment. Twelve participants. Completed 11 October 2021.
- NCT03323749 MMPOWER-3 — Phase 3, terminated, n=218. Stealth BioTherapeutics, primary mitochondrial myopathy, 218 randomised. The published report states the study "did not meet its primary endpoints assessing changes in the 6MWT and PMMSA total fatigue score" — the six-minute-walk difference was −3.2 metres (95% CI −18.7 to 12.3; p = 0.69).
- NCT02788747 — Phase 2, completed, n=71. Stealth BioTherapeutics. "Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With REDUCED Ejection Fraction." 71 participants, completed October 2017. This is the heart-failure programme Marek's page appears to be describing, and it is HFrEF, not HFpEF.
Three separate things have moved past this page. First, elamipretide is no longer investigational: FORZINITY (elamipretide hydrochloride) injection, from Stealth BioTherapeutics, carries a current FDA label — accelerated approval, "indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg", based on knee-extensor strength as an intermediate endpoint. Selling a compounded copy of a newly approved orphan drug is a materially different act from selling an unapproved peptide, and the page describes neither. Second, "Phase II/III for HFpEF" names the wrong disease: every registered elamipretide heart-failure study is in heart failure with REDUCED ejection fraction or in acute decompensation, and there is no HFpEF trial in the registry. Third, "Phase II evidence showing improved exercise capacity" is true only if you stop reading at phase 2 — the phase 3 that followed, MMPOWER-3, randomised 218 people and missed both primary endpoints, including the six-minute walk. What Marek sells is none of these populations: it lists "Age-related mitochondrial dysfunction" as an indication, for which no trial of this molecule exists.11,12,13,14
CJC-1295 + Ipamorelin injectable (subcutaneous) vialCJC-1295 and ipamorelin · Compounded (503A)Claim reaches past the trials
“Most widely prescribed peptide stack in optimization medicine. CJC-1295 (GHRH analog with albumin-binding DAC linker, ~6 to 8 day half-life) combined with ipamorelin (selective GHRP) for synergistic GH release 3 to 10x either alone… Synergistic GH release exceeding either alone. Extended CJC-1295 half-life allows 2 to 3x/week dosing. Preserved physiologic pulsatility. Improved lean mass, reduced visceral fat.”
Phase 2 only
- NCT00267527 — Phase 2, terminated, n=120. Sponsor ConjuChem. "A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks" in HIV patients with visceral obesity. Enrolment 120, ran December 2005 to September 2006. It is the ONLY registered trial of CJC-1295 anywhere in the world, and it was TERMINATED.
- NCT01280344 — Phase 2, completed, n=320. Helsinn Therapeutics (U.S.). Ipamorelin versus placebo for recovery of gastrointestinal function — a dose-finding study in gastrointestinal dysmotility, 320 participants, completed May 2014. Not a body-composition study.
- NCT00672074 — Phase 2, completed, n=117. Helsinn Therapeutics (U.S.). Ipamorelin for the management of post-operative ileus, 117 participants, completed December 2009. Also not a body-composition study.
The pharmacology is defensible and the outcome is not. Teichman et al. did show, in healthy adults, that a single subcutaneous dose of CJC-1295 raised mean plasma growth hormone 2- to 10-fold for six days or more and IGF-1 1.5- to 3-fold for nine to eleven days, with an estimated half-life of 5.8 to 8.1 days — so the half-life figure and the hormone-release figure are broadly the trial's own. What that study measured was hormone concentrations in blood. "Improved lean mass, reduced visceral fat" is a body-composition outcome, and no registered trial of either molecule has measured it: the entire CJC-1295 registry is one terminated phase 2 in HIV-associated visceral obesity, and the entire ipamorelin registry outside that stack is two completed phase 2 studies of post-operative ileus and gastrointestinal recovery. Both molecules are separately named on FDA's page of bulk substances that may present significant safety risks; for CJC-1295 the agency's own entry states that it "may pose risk for immunogenicity for certain routes of administration".1,15,16,17,18
Dispensing chain
Who actually fills your prescription
- Anazao Health Corporation — 5710 Hoover Boulevard, Tampa, FL 33634
- ReviveRX — 3831 Golf Dr A, Houston, TX 77018
- TMC Acquisition, LLC. DBA Tailor Made Compounding — 200 Moore Dr, Nicholasville, KY 40356
- Empower Clinic Services LLC DBA Empower Pharmacy — 7601 North Sam Houston Pkwy W Ste 100, Houston, TX 77064
- DYL LLC DBA South Lake Pharmacy — 38101 5th Ave, Zephyrhills, FL 33542
- Honeybee Health, Inc. — 3515 Helms Ave, Culver City, CA 90232
- Strive Pharmacy — 1275 E Baseline Rd #104, Gilbert, AZ 85233
Read the full account
This is the best dispensing disclosure on this site, and it is followed immediately by the worst sentence about it. The terms and conditions name all seven fulfilment pharmacies with street address, phone number and email, and then state that "your prescription(s) may be filled by and transferred between any of the Pharmacies" — so a customer knows both who might make the drug and that it may move between them. Marek is also unusually clear about what it is not: "Marek Health is not a healthcare clinic. We do not administer healthcare, nor do we prescribe treatments or medications. Instead, Marek Health is a platform that connects clients with highly specialized healthcare providers." Against that, the description of those pharmacies is a designation that does not exist. The /faqs page states "We only use 503A/503B FDA Approved and Audited compounding pharmacies as our fulfillment partners." The rendered home page says "Exclusive access to Marek Health's FDA-approved pharmacies and supplement dispensaries." The JSON-LD served on /trt and /testosterone repeats it as machine-readable data: "Coordination of delivery from FDA-approved pharmacies and supplement dispensaries." FDA approves drug PRODUCTS. It registers outsourcing facilities under section 503B, which subjects them to inspection and CGMP and approves nothing; it does not license or approve 503A pharmacies at all; and no compounded preparation from any of these seven holds an FDA approval. The value of naming them is that a reader can check, so this review did. Two of the seven appear in the live FDA warning-letter index. Empower Clinic Services, LLC dba Empower Pharmacy, at the exact Houston address Marek prints, received warning letter 700964 dated 2 April 2025, whose body states that FDA investigators "noted serious deficiencies in your practices for producing drug products, which put patients at risk" and that drug products "intended or expected to be sterile were prepared, packed, or held under insanitary conditions"; the datatable shows no close-out date. AnazaoHealth Corporation received a 503B letter dated 18 August 2021 — but that letter is addressed to 7465 W. Sunset Road, Suite 1200, Las Vegas, NV 89113, a different facility from the Tampa address in Marek's terms, so it is reported here as the same corporation at a different registered site and is not attributed to the pharmacy Marek names. ReviveRX, Tailor Made Compounding, South Lake Pharmacy, Honeybee Health and Strive Pharmacy each returned recordsFiltered=0 on the same query shape.
Read on August 2026 from https://marekhealth.com/terms-and-conditions
Quality
Third-party testing, and what is published
Describes a testing regime
Nothing published on the pages searched
Certificate of analysis readable
No lot report a buyer can open
Read the full testing account
Marek describes no testing regime for any prescription product, and the measurement is a clean one. Across all 186 front-end JavaScript chunks — 5.1 MB, containing every word the site renders, including the 112-treatment catalogue it does not render — the strings "certificate of analysis", "sterile", "sterility", "USP" and "batch test" occur ZERO times, and "COA" appears as a standalone word zero times. The only testing language on the site is "Third-party tested, no proprietary blends", and it is attached to the supplements shop in the navigation menu, not to a compounded medication. What stands in place of a testing disclosure is a claim about the pharmacies: "We only use 503A/503B FDA Approved and Audited compounding pharmacies as our fulfillment partners." "Audited" is doing real work in that sentence — FDA did inspect one of the seven, in September and October 2024, and issued a warning letter over sterility practices six months later. "FDA Approved" is doing none: it describes nothing that exists. A LegitScript badge in the footer links to legitscript.com's public checker with marekhealth.com pre-filled; on 2026-08-09 that checker returned a client-rendered shell of essentially identical size (≈82 KB) for marekhealth.com, for a known large telehealth control domain, and for an invented domain, so the lookup distinguishes nothing and the badge is reported as displayed and not independently confirmed.
Read on August 2026 from https://marekhealth.com/faqs
Licensing
Licensed to dispense, and where
Coverage
All 50 states for the Guided Optimization® program, per the provider's own FAQ; treatment-level exclusions exist but are published on no reachable page
Read the full licensing claim
The /faqs page states: "Marek Health's Guided Optimization® program is available in all 50 states across the United States. However, specific treatments and diagnostics may be limited to certain states." A separate FAQ explains why, and is unusually specific about the mechanism: "The regulatory landscape for pharmaceutical medications and health services varies greatly from state to state, and changes almost daily. Some states have imposed restrictions on: Restriction on Days Supply allowed per order; Restriction on import of specific medications out of state; Outright ban of certain medications." What is never published is WHICH treatment is unavailable WHERE. That information exists and is written down — the unreleased catalogue carries a per-treatment exclusion list, and it is granular (BPC-157 excluded in NE; tesamorelin in CA, LA, MA and OH; SS-31 in CA, NM and OH; CJC-1295 with ipamorelin in CA, LA, MA, OH and IA) — but no page renders it, so `statesExcluded` is left empty rather than populated from a document the provider has not published. The service is also US-only: "We currently only work with U.S. based residents." Nothing here was verified against a state board.
Read on August 2026 from https://marekhealth.com/faqs
Regulatory
The FDA warning letter
Checked, and none found
Assessment
What holds up, and what does not
- It names every pharmacy that might fill your prescription — seven of them, with street address, phone number and email, in the terms of service — and states plainly that "your prescription(s) may be filled by and transferred between any of the Pharmacies". Nothing else reviewed here comes close.
- It says what it is not: "Marek Health is not a healthcare clinic. We do not administer healthcare, nor do we prescribe treatments or medications. Instead, Marek Health is a platform that connects clients with highly specialized healthcare providers for their healthcare needs."
- The unreleased BPC-157 copy contains the sentence this whole category avoids: "No completed human clinical trials; all evidence is preclinical", with the efficacy bullet itself labelled "(animal models)" and "No completed human safety trials" listed under serious risks.
Show 5 more
- The entry price is published without a funnel: $299 for the intake assessment and a stated "minimum $450 lab panel purchase required", both on the rendered home page.
- It explains its own fulfilment delay honestly, describing a manual multi-pharmacy process — "If your order is being fulfilled with multiple pharmacies, our staff has to log into each pharmacy portal and submit the order" — rather than promising same-day shipping.
- The direct-pay notice is explicit and separately published: the customer acknowledges that Marek "will not bill any insurance or other third party payers", that no representation of reimbursement has been made, and that no claim will be submitted to Medicare or Medicaid.
- Lab work is the gate rather than an upsell: the FAQ states "We require, at a minimum, the comprehensive male/female panel to begin the guided optimization process" and "We require all clients at Marek Health to complete thorough diagnostic lab work at least every 6 months."
- The corporate identity is published in machine-readable form and matches: Marek Health LLC, 35 W Huron St # 1000, Pontiac, MI 48342, with a toll-free number and stated office hours.
- The live site sells "therapeutic peptides" and names no peptide molecule on any page a customer can reach. A drug you cannot name is a drug you cannot look up.
- The molecule-level catalogue exists and is shipped to every visitor's browser — 112 treatments, thirteen of them peptides, with claims, dosage forms, citations and state exclusions — inside a public JavaScript chunk that renders on no page. The routes are in the build manifest and robots.txt disallows them.
- Eight of those thirteen peptides are named on FDA's published page of bulk drug substances that may present significant safety risks: BPC-157, TB-500, CJC-1295, ipamorelin acetate, MOTs-C, selank acetate, semax and GHK-Cu for injectable routes.
Show 11 more
- "FDA-approved pharmacies" appears in rendered copy on the home page and in the JSON-LD structured data on /trt and /testosterone. There is no such designation. FDA approves products, registers outsourcing facilities, and approves no pharmacy.
- "We only use 503A/503B FDA Approved and Audited compounding pharmacies" compresses two different regulatory regimes into one label and attaches an approval to both. A preparation is made under 503A or under 503B; the oversight differs; neither is an approval.
- Empower Pharmacy, named in the terms at the exact address FDA used, received a warning letter dated 2 April 2025 alleging that products "intended or expected to be sterile were prepared, packed, or held under insanitary conditions". The site's only quality claim about its pharmacies is the one quoted above.
- The tesamorelin card misdates its own primary citation by three years and reverses the placebo result: the 412-patient phase 3 was published in 2007, and visceral fat rose 5.0% on placebo, not fell 0.5%.
- The same card cites "The Lancet Healthy Longevity (2021)" for a cognition result. A PubMed search of that journal for tesamorelin or growth-hormone-releasing hormone returns zero records; the trial described was published in Archives of Neurology in 2012.
- The SS-31 card says the molecule is "In Phase II/III for HFpEF". No elamipretide trial in HFpEF exists; the heart-failure programme is in reduced ejection fraction. The card also omits that the phase 3 in mitochondrial myopathy missed both primary endpoints, and that elamipretide now has an FDA approval under the name FORZINITY.
- "Improved lean mass, reduced visceral fat" is offered for the CJC-1295 and ipamorelin stack. The only registered CJC-1295 trial in the world was terminated in 2006, and the only completed ipamorelin trials are two phase 2 studies of post-operative ileus.
- No certificate of analysis exists for any lot, and no testing regime is described for any prescription product: "certificate of analysis", "sterile", "sterility" and "USP" occur zero times across 5.1 MB of front-end code.
- Which treatments are unavailable in which states is written down and unpublished. The reachable answer is "specific treatments and diagnostics may be limited to certain states"; the specific answer is in the same unreachable bundle.
- Sales are effectively final. "Web sales are final and cannot be cancelled once an order has been placed", appointment cancellations without a reschedule are non-refundable, and the booking payment is "a non-refundable deposit".
- The published sitemap is broken in a way that suggests nobody reads it: every URL in static-sitemap.xml begins "images.marekhealth.com/" instead of "https://marekhealth.com/", so the 37 entries in it resolve to nothing.
Verdict
The bottom line
Marek Health is the clearest case on this site of a company that has done the hard part and skipped the easy one. The hard part is the dispensing chain: seven pharmacies named in the terms with addresses you can dial, an explicit statement that your prescription may move between them, and an explicit statement that Marek is a platform and not a clinic. That disclosure is what let this review check the pharmacies at all, and checking them found a 2025 warning letter over sterile practices at one of the seven — which is an argument for naming pharmacies, not against it. The easy part is naming the drug. Marek sells "therapeutic peptides" on every page and names not one molecule anywhere a customer can read, while a complete thirteen-peptide catalogue — with the honest line "No completed human clinical trials; all evidence is preclinical" written into the BPC-157 entry — sits finished in the JavaScript bundle behind a route that returns the home page. Where that catalogue does reach past its evidence it does so in checkable ways: a phase 3 misdated by three years with its placebo arm reversed, a journal citation for a paper that does not exist in that journal, a heart-failure indication naming the wrong half of the disease, and a molecule described as investigational four months after it acquired an FDA label. None of that is visible to a buyer. What is visible is a sentence, on the home page and in the structured data, promising access to "FDA-approved pharmacies" — a status no pharmacy in the United States has.
Opens marekhealth.com. A link is not a recommendation to take anything.
The catalogue is in your browser and not on the website
Open marekhealth.com and you are told, in the navigation menu, that Guided Optimization® is "a clinically supervised program featuring physician-prescribed TRT, GLPs, and therapeutic peptides". Open /telehealth, /performance, /trt, /weight-loss or /faqs and you are told versions of the same thing: "GLP-1s, peptides, TRT", "600+ medications, peptides & supplements".
Now try to find out which peptide.
On 9 August 2026 every URL in the site's four sitemaps was requested, the Next.js build manifest was read, and all 186 JavaScript chunks it references were downloaded — 5.1 MB, which is every word the site is capable of rendering. Across the pages a reader can actually reach, not one peptide molecule is named.
They are all in the bundle.
A single file — `/_next/static/chunks/8961-d221c81a8bb1a91c.js`, served to everyone who loads the home page — contains a complete treatment catalogue: 112 entries, each with a slug, a category, a headline claim, a dosage form, a mechanism paragraph, cited "clinical evidence", a side-effect list, a monitoring list and a state-availability note.
112
13
8
0
Thirteen of the 112 are peptides: BPC-157, TB-500, CJC-1295 with ipamorelin, ipamorelin alone, MOTS-c, selank, semax, GHK-Cu, sermorelin, tesamorelin, somatropin, SS-31 and thymosin alpha-1.
Each carries a `canonical_path` of `/treatments/<slug>`. That route does not exist — a request returns the site's 404. The routes that do exist in the build manifest are `/v3/treatments/[slug]`, and robots.txt carries the line `Disallow: /v3/`.
Loaded in a real browser on 9 August 2026, `marekhealth.com/v3/treatments/bpc-157` finishes at `https://marekhealth.com/` and renders the home page. So does `/v3/treatments`, `/v3/shop` and `/v3/pricing`. No link in the live navigation points anywhere near them.
This is not a dead storefront serving one document for every path — that was checked too. The home page is 5,623 bytes, `/telehealth` is 4,924, and an invented path returns a distinct 4,910-byte 404 with a different md5. The server knows the difference between a real route and a fake one. The /v3 tree is specifically unreleased.
The result is a company that has written the molecule-level detail this site exists to ask for, and published none of it.
Full analysis — 5 more sectionsEight of the thirteen are on a list FDA publishes · "FDA-approved pharmacies" · The part where naming your pharmacy pays off · Four checkable errors on the pages nobody can read · What it adds up to
Eight of the thirteen are on a list FDA publishes
FDA maintains a page titled "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", content current as of 22 April 2026. 1 It sets out substances the agency reviewed when they were nominated for the 503A bulks list and for which it identified a potential significant safety risk, together with the risk it found.
Read Marek's thirteen against it.
Marek's peptide catalogue, checked against FDA's safety-risk page
| Molecule | On FDA's safety-risk page | Status of the molecule |
|---|---|---|
| BPC-157 | Yes | No approved product |
| TB-500 (thymosin beta-4 fragment) | Yes | No approved product |
| CJC-1295 | Yes | No approved product |
| Ipamorelin acetate | Yes | No approved product |
| MOTs-C | Yes | No approved product |
| Selank acetate | Yes | No approved product |
| Semax (heptapeptide) | Yes | No approved product |
| GHK-Cu (injectable routes) | Yes | No approved product |
| Sermorelin | No | Approval withdrawn 2008 |
| Tesamorelin | No | Approved — EGRIFTA WR |
| Somatropin | No | Approved — many products |
| SS-31 (elamipretide) | No | Approved 2025 — FORZINITY |
| Thymosin alpha-1 | No | No US approval |
Eight for thirteen. FDA's entries are not identical and are not vague. On BPC-157: compounded drugs containing it "may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities". On KPV — which Marek sells inside a combination capsule with BPC-157 — the agency "has not identified any human exposure data on drug products containing KPV administered via any route of administration". On CJC-1295, the same immunogenicity language. 1
None of those molecules complies with a USP or NF monograph, is a component of an approved drug, or appears on the 503A bulks list — the three conditions under which a state-licensed pharmacy may lawfully compound with a bulk substance at all. 2 If the distinction between the two compounding regimes is unfamiliar, 503A and 503B are not two words for the same thing.
The remaining five are the interesting ones, and they are interesting for the opposite reason: four of the five are, or were, the active ingredient of a drug with a US approval. That is precisely the status the other eight do not have.
"FDA-approved pharmacies"
Here is what the live site does say about how your medication is made. This is on the rendered home page, in the list of what the $299 intake buys:
Delivered To Your Door: Exclusive access to Marek Health's FDA-approved pharmacies and supplement dispensaries.
And on /faqs, at the end of an otherwise careful explanation of why compounded orders take days rather than minutes:
We only use 503A/503B FDA Approved and Audited compounding pharmacies as our fulfillment partners.
And in the JSON-LD structured data served on /trt and /testosterone, where it is machine-readable rather than merely readable: "Coordination of delivery from FDA-approved pharmacies and supplement dispensaries."
There is no such thing as an FDA-approved pharmacy. FDA approves drug products — a new drug application, a National Drug Code, a label the agency has reviewed for that specific product. Under section 503B it registers outsourcing facilities, which subjects them to inspection and to current good manufacturing practice and approves nothing. Under 503A it does not license pharmacies at all; states do. And no compounded preparation from any pharmacy holds an approval, which is why the compounded preparation is not the trial drug.
The phrase "503A/503B" compresses the two regimes into one label. A given vial is made under one or the other; the record-keeping, the inspection regime and the limits on what may be compounded all differ.
The part where naming your pharmacy pays off
Now the disclosure that makes this review possible, and it is genuinely the best in the category. Marek's terms and conditions contain this:
Our Services provides access to prescription fulfillment services offered by the following pharmacies: Anazao Health Corporation (5710 Hoover Boulevard, Tampa, FL 33634), ReviveRX (3831 Golf Dr A, Houston, TX 77018), TMC Acquisition, LLC. DBA Tailor Made Compounding (200 Moore Dr, Nicholasville, KY 40356), Empower Clinic Services LLC DBA Empower Pharmacy (7601 North Sam Houston Pkwy W Ste 100, Houston, TX 77064), DYL LLC DBA South Lake Pharmacy (38101 5th Ave, Zephyrhills, FL 33542), Honeybee Health, Inc. (3515 Helms Ave, Culver City, CA 90232), and Strive Pharmacy (1275 E Baseline Rd #104, Gilbert, AZ 85233) (the "Pharmacies") … You agree and understand that your prescription(s) may be filled by and transferred between any of the Pharmacies
Seven companies, seven street addresses, seven phone numbers, and a plain statement that your prescription may move between them. Most telehealth brands in this category name none.
The point of naming them is that a reader can check. So this review checked all seven against the live FDA warning-letter index.
Empower Clinic Services, LLC dba Empower Pharmacy — the address on FDA's letter is 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064, character for character the address Marek prints. Warning letter 700964, dated 2 April 2025, following an inspection from 24 September to 4 October 2024. The body states that investigators "noted serious deficiencies in your practices for producing drug products, which put patients at risk", and that drug products "intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health". 19 The datatable carries no close-out date.
AnazaoHealth Corporation received a warning letter dated 18 August 2021 concerning its registration as a 503B outsourcing facility. 20 That letter is addressed to 7465 W. Sunset Road, Suite 1200, Las Vegas, NV 89113 — a different facility in a different state from the Tampa address in Marek's terms. It is reported here as the same corporation at a different registered site, and nothing more is claimed from it.
ReviveRX, Tailor Made Compounding, South Lake Pharmacy, Honeybee Health and Strive Pharmacy each returned zero rows.
A warning letter discloses; it does not disqualify, and most compounders of any size have one somewhere in their history. What is uncomfortable here is the pairing: the one quality claim Marek makes about these seven companies is that they are "FDA Approved and Audited". "Audited" turns out to be true in a way the sentence did not intend.
Four checkable errors on the pages nobody can read
Grading the catalogue is grading a document the public has been given and not shown. It is worth doing anyway, because the errors are the specific, checkable kind.
Tesamorelin: the citation is off by three years and the placebo arm is reversed
The card reads: "Tesamorelin in HIV-Infected Patients with Abdominal Fat — New England Journal of Medicine (2010): Phase 3 (n=412): 15.2% VAT reduction vs -0.5% placebo at 26 weeks."
The 412-patient phase 3 is NCT00123253, and it was published in the New England Journal of Medicine in 2007. 6 7 Visceral adipose tissue measured by CT fell 15.2% on tesamorelin — and rose 5.0% on placebo. Not a 0.5% fall. The direction of the comparator has been flipped and its size cut by a factor of ten, which happens to make the drug's margin look smaller rather than larger, so this is carelessness rather than salesmanship. It is still wrong on a page selling the drug.
The second card reads: "Tesamorelin and Cognition in Older Adults — The Lancet Healthy Longevity (2021): Improved verbal memory and executive function over 20 weeks in older adults including those with MCI."
A PubMed search of The Lancet Healthy Longevity for tesamorelin or growth-hormone-releasing hormone returns zero records. The trial being described — 20 weeks, verbal memory and executive function, adults with mild cognitive impairment and healthy older adults — is Baker et al., Archives of Neurology, 2012. 9 Right result, wrong journal, wrong decade.
Underneath the citations sits the swap this category always makes. The approved label reads: "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy," and, under Limitations of Use, "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect." 8 Marek at least labels the metabolic-syndrome use "(off-label)". Outside HIV the registry holds one phase 2 study, 60 participants, completed January 2012. 10 This is the recurring shape in the growth-hormone secretagogue family.
SS-31: the wrong half of a disease, and a drug that got approved
The card says elamipretide is "In Phase II/III for HFpEF and Barth syndrome" and lists "Phase II evidence showing improved exercise capacity" and "Favorable safety in completed trials".
Three things have moved.
There is no HFpEF trial. Every registered elamipretide heart-failure study is in heart failure with reduced ejection fraction or in acute decompensation — NCT02788747, 71 participants, "Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction". 13 Preserved and reduced ejection fraction are different diseases with different treatments.
The phase 3 missed. MMPOWER-3 randomised 218 people with primary mitochondrial myopathy. Its published report states the study "did not meet its primary endpoints assessing changes in the 6MWT and PMMSA total fatigue score" — the six-minute-walk difference was −3.2 metres, 95% CI −18.7 to 12.3, p = 0.69. 14 "Phase II evidence showing improved exercise capacity" is true only if you stop reading before the phase 3. That is what a failed trial looks like, and it is why phase 2 results are not a result.
The molecule has an approval now. FORZINITY (elamipretide hydrochloride) injection carries a current FDA label from Stealth BioTherapeutics: "FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint." 11 The Barth-syndrome trial behind it, TAZPOWER, enrolled twelve people. 12
Marek sells a compounded copy of that molecule for "Age-related mitochondrial dysfunction", a population no trial of it has ever studied.
CJC-1295 and ipamorelin: a hormone level is not a body
The stack is described as "Most widely prescribed peptide stack in optimization medicine", with the benefit "Improved lean mass, reduced visceral fat".
The pharmacology half checks out. Teichman et al. gave CJC-1295 to healthy adults and reported dose-dependent increases in mean plasma growth hormone of two- to ten-fold lasting six days or more, IGF-1 up 1.5- to three-fold for nine to eleven days, and an estimated half-life of 5.8 to 8.1 days. 18 Marek's "~6 to 8 day half-life" is that paper's number.
What that study measured was hormone concentrations in blood. Lean mass and visceral fat are different objects — the distinction between a surrogate marker and an outcome.
For those outcomes:
- Complete
CJC-1295 registered trials worldwide
Exactly one — NCT00267527, phase 2, HIV patients with visceral obesity, 120 participants, ConjuChem. Status: TERMINATED, 2006.
- Complete
Ipamorelin completed phase 2 trials
Two — both post-operative ileus and gastrointestinal recovery, sponsored by Helsinn, 117 and 320 participants.
- 3 — Not reached
A trial of the stack in body composition
None registered, anywhere, for either molecule.
BPC-157: the one that gets it right
And then the entry that should be famous, and is currently visible to nobody:
Synthetic 15-amino-acid pentadecapeptide derived from gastric juice glycoprotein. Strong tissue-protective and healing properties across multiple organ systems in animal models. No completed human clinical trials; all evidence is preclinical.
Its efficacy bullet reads "Accelerated tendon/ligament/muscle repair (animal models)", and its serious-risks list opens with "No completed human safety trials".
That is correct. A PubMed search for BPC-157 or "BPC 157" in title or abstract, restricted to the randomised-controlled-trial publication type, returns zero records as of August 2026. 3 The registry holds a phase 1 pilot whose status has read UNKNOWN since a listed completion of March 2016, with no results posted 4, and a phase 2 hamstring-strain trial that began recruiting on 2 February 2026 and estimates completion in 2028. 5 The gap between what people report about recovery peptides and what has been tested is the whole subject, and Marek's own copy states the gap plainly.
Two things it still does not say. It does not mention FDA's safety-risk entry for BPC-157, which bears directly on the four dosage forms offered — an injectable vial, a 1000 mcg oral capsule, a 500 mcg/mL nasal spray and a combination capsule with KPV. No registered study has tested an oral or nasal route; route changes the drug. And it does not say any of it where a customer could read it.
What it adds up to
Set the two halves beside each other.
On one side: seven pharmacies named with addresses, a plain statement that Marek is a platform and not a clinic, a published $299 entry price with a stated $450 lab minimum, a mandatory comprehensive panel before anything is prescribed, a direct-pay acknowledgment that forecloses insurance ambiguity, and an unusually frank explanation of why a compounded order takes days.
On the other: a catalogue of thirteen peptides that exists, is finished, is downloaded into every visitor's browser, and is rendered nowhere; eight of those thirteen named on FDA's own safety-risk page; a promise of "FDA-approved pharmacies" on the home page and inside the structured data; and a warning letter over insanitary conditions at one of the seven companies the terms name.
The company that wrote "No completed human clinical trials; all evidence is preclinical" knows exactly what a reader is owed. It has already written it down. It is a claim outrunning its evidence only in the places where the catalogue reaches — and everywhere else, it is a claim with no molecule attached at all.
Questions
Frequently asked questions
Which peptides does Marek Health sell?
No page on the live site names one. The site sells "therapeutic peptides" as a category on the home page, /telehealth, /trt, /weight-loss and /performance, and names no molecule on any of them. Thirteen peptides are named in a treatment catalogue that ships inside a public JavaScript file the site serves to every visitor — BPC-157, TB-500, CJC-1295 with ipamorelin, ipamorelin alone, MOTS-c, selank, semax, GHK-Cu, sermorelin, tesamorelin, somatropin, SS-31 (elamipretide) and thymosin alpha-1 — but the routes that would render those pages resolve to the home page, and robots.txt disallows the path they sit under. That list was read from chunk 8961-d221c81a8bb1a91c.js on 9 August 2026.
Does Marek Health say which pharmacy fills the prescription?
Yes, and it is the most complete such disclosure found on any provider reviewed here. The terms and conditions name seven fulfilment pharmacies with street address, telephone number and email: Anazao Health Corporation (Tampa, FL), ReviveRX (Houston, TX), TMC Acquisition LLC dba Tailor Made Compounding (Nicholasville, KY), Empower Clinic Services LLC dba Empower Pharmacy (Houston, TX), DYL LLC dba South Lake Pharmacy (Zephyrhills, FL), Honeybee Health Inc. (Culver City, CA) and Strive Pharmacy (Gilbert, AZ). The same paragraph states that "your prescription(s) may be filled by and transferred between any of the Pharmacies". Naming them is a pro, and it is what allowed this review to check their regulatory histories.
Do any of those pharmacies have FDA warning letters?
Two entries in the live index match, and they match differently. Empower Clinic Services, LLC dba Empower Pharmacy received warning letter 700964 dated 2 April 2025, addressed to 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064 — the same address Marek prints. Its body states that products "intended or expected to be sterile were prepared, packed, or held under insanitary conditions", and the datatable shows no close-out date. AnazaoHealth Corporation received a 503B letter dated 18 August 2021, but that letter is addressed to a Las Vegas, Nevada facility, not the Tampa address Marek lists, so it belongs to the same corporation at a different registered site and is reported as such. ReviveRX, Tailor Made Compounding, South Lake Pharmacy, Honeybee Health and Strive Pharmacy each returned zero rows on the same query. A warning letter discloses; it does not disqualify.
Is an "FDA-approved pharmacy" a real thing?
No. FDA approves drug products — each with a new drug application, a National Drug Code and an agency-reviewed label. Under section 503B it registers outsourcing facilities, which makes them subject to inspection and to current good manufacturing practice but approves nothing they make. Under 503A it does not license pharmacies at all; states do. Marek's home page promises "Exclusive access to Marek Health's FDA-approved pharmacies", its FAQ says "We only use 503A/503B FDA Approved and Audited compounding pharmacies as our fulfillment partners", and the JSON-LD structured data on /trt and /testosterone repeats the phrase in machine-readable form. No compounded preparation from any of the seven named pharmacies holds an FDA approval.
Has Marek Health itself received an FDA warning letter?
No. On 9 August 2026 the live FDA warning-letter index was queried for "marek", "marek health", "marekhealth" and "marek llc", with the returned row count compared to recordsFiltered on each query so that a truncated page could not pass as a clean result. Every query returned recordsFiltered=0 and zero rows. A positive control query for "skinnyrx" returned Lean Rx, Inc. dba SkinnyRx dated 20 February 2026 under the identical query shape, and the close-out column was validated separately against Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy, whose 31 March 2023 letter carries a close-out date of 30 October 2023. So the zeroes are real zeroes. Note the bound: no warning letter to Marek is not an inspection record of the pharmacies that make its medications.
Is there evidence for BPC-157?
Not human evidence, and Marek's own unreleased copy says so: "No completed human clinical trials; all evidence is preclinical." That is accurate. As of August 2026 a PubMed search for BPC-157 or "BPC 157" in title or abstract, restricted to the randomised-controlled-trial publication type, returns zero records. Two studies are registered: NCT02637284, a phase 1 safety and pharmacokinetics pilot in healthy volunteers with an estimated enrolment of 42, whose status has read UNKNOWN since a listed completion of March 2016 with no results posted; and NCT07437547, a phase 2 trial in acute grade II hamstring strain that began recruiting on 2 February 2026 toward 120 participants and estimates completion in 2028. Marek's catalogue lists an oral capsule and a nasal spray alongside the injection, and no registered study has tested either route. This site does not tell you what to take and makes no safety claim; it reports what has and has not been tested.
Why does this review say the SS-31 page is out of date?
Because three separate facts have moved past it. The page says elamipretide is "In Phase II/III for HFpEF" — no HFpEF trial of the molecule exists; the registered heart-failure studies are in reduced ejection fraction and in acute decompensation. The page says "Phase II evidence showing improved exercise capacity" — the phase 3 that followed, MMPOWER-3, randomised 218 people with primary mitochondrial myopathy and its published report states it "did not meet its primary endpoints", with a six-minute-walk difference of −3.2 metres (p = 0.69). And the page describes an investigational drug — elamipretide now carries an FDA label as FORZINITY, approved under accelerated approval to improve muscle strength in Barth syndrome patients weighing at least 30 kg. Marek sells a compounded version for "age-related mitochondrial dysfunction", which is not a population any trial of it has studied.
What does Marek Health cost?
The entry is published and the medication is not. The home page states $299 for the intake assessment and "minimum $450 lab panel purchase required", and the unreleased catalogue repeats it: "Pricing starts with a $299 intake assessment with your dedicated health coach. Lab pricing starts at $450. If your provider determines a prescription is appropriate, medication cost is separate and varies by dose." No figure for any medication appears anywhere on the site, and Marek does not bill insurance — the direct-pay notice has the customer acknowledge that payment "will be billed to and paid by me directly" and that no claim will be submitted to Medicare or Medicaid. Refunds are limited: "Web sales are final and cannot be cancelled once an order has been placed", appointment cancellations without a reschedule request are non-refundable, and reschedules inside 24 hours may carry a fee of up to $50.
Does Marek Health serve my state?
The FAQ says "Marek Health's Guided Optimization® program is available in all 50 states across the United States. However, specific treatments and diagnostics may be limited to certain states", and a separate FAQ explains the mechanism honestly — states restrict days supply per order, restrict out-of-state import of specific medications, or ban certain medications outright. What is never published is which treatment is unavailable where. That information is written down: the unreleased catalogue carries per-treatment exclusions, and they are granular. It renders on no page, so this review leaves the exclusion list empty rather than populating it from a document the provider has not published. The service is US-residents-only.
Does Marek Health publish testing or a certificate of analysis?
No, and the measurement is unusually clean. Across all 186 front-end JavaScript chunks — 5.1 MB, containing every word the site can render, including the catalogue it does not render — the strings "certificate of analysis", "sterile", "sterility", "USP" and "batch test" occur zero times, and "COA" appears as a standalone word zero times. The only testing language anywhere is "Third-party tested, no proprietary blends", attached to the supplements shop in the navigation menu rather than to any compounded medication. In place of a testing disclosure there is a claim about the pharmacies — "503A/503B FDA Approved and Audited" — of which the first half describes nothing that exists. A LegitScript badge in the footer links to that company's public checker with marekhealth.com pre-filled; on 9 August 2026 the checker returned a client-rendered shell of essentially identical size for marekhealth.com, for a known large control domain and for an invented domain, so it distinguishes nothing and the badge is reported as displayed only.
Glossary
Key terms
Show definitions
- Build manifest
- A file a Next.js site publishes listing every route it was built with and the JavaScript each one needs. It is how this review established that /v3/treatments/[slug] is a real route in Marek's application, and that no live page links to it.
- 503A bulks list
- The list of bulk drug substances a state-licensed pharmacy may lawfully compound with when the substance has no USP or NF monograph and is not a component of an approved drug. It is short and it is made by rulemaking. None of the eight peptides above is on it.
- Outsourcing facility (503B)
- A compounder that has elected to register with FDA, is subject to FDA inspection and to current good manufacturing practice, and may make batches without a patient-specific prescription. Registration is not approval, and the phrase "FDA-approved pharmacy" describes no status FDA grants.
- Accelerated approval
- An FDA pathway that approves a drug on an intermediate endpoint reasonably likely to predict clinical benefit, with continued approval contingent on a confirmatory trial. FORZINITY's Barth syndrome approval rests on knee-extensor muscle strength on this basis.
- HFpEF vs HFrEF
- Heart failure with preserved ejection fraction and heart failure with reduced ejection fraction: different diseases, different mechanisms, different treatments. Elamipretide's registered heart-failure programme is the second. Marek's page names the first.
- Certificate of analysis
- A lot-specific laboratory report stating what was tested and what the results were. Saying a pharmacy is inspected and publishing a report a customer can read are different claims. Marek makes neither for any compounded product.
Method
How we checked this
Non-product facts last checked August 2026. Read the editorial policy for the rules this page is held to.
Read our methodology
Claims read first-party
Every quoted claim was read off Marek Health's own pages on the date stamped against it, and the URL it came from is published beside it.
Trials read from the registry
Phase, status and enrolment come from ClinicalTrials.gov; identifiers and journals from PubMed's own records. Nothing here is cited from memory.
Absence claims bounded
Where we report that no trial exists, the page says what was searched, where, and when — never an unbounded claim that nobody has tested something.
Letters matched on full name
FDA letters are matched on the complete company name. A substring match would attach one firm's regulatory history to another with a similar name.
Sources
References
Show all 20 sources
- US Food and Drug Administration (2026). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — content current as of 04/22/2026. Names BPC-157, thymosin beta-4 fragment (LKKTETQ, "also known as TB-500"), CJC-1295, ipamorelin acetate, MOTs-C, selank acetate (TP-7), semax (heptapeptide), GHK-Cu for injectable routes and KPV, each with FDA's stated potential significant safety risk. Read 2026-08-09. fda.gov. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- US Food and Drug Administration (2026). Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — the 503A bulks list, the interim-policy categories, and the condition that a bulk substance comply with a USP or NF monograph, be a component of an FDA-approved drug, or appear on the list. Read 2026-08-09. fda.gov. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- US National Library of Medicine (2026). PubMed search: (BPC-157[tiab] OR "BPC 157"[tiab]) AND randomized controlled trial[pt] — 0 records. Run 2026-08-09. PubMed. https://pubmed.ncbi.nlm.nih.gov/?term=%28BPC-157%5Btiab%5D+OR+%22BPC+157%22%5Btiab%5D%29+AND+randomized+controlled+trial%5Bpt%5D
- PharmaCotherapia d.o.o. (2026). PCO-02 — Safety and Pharmacokinetics Trial, NCT02637284 — "Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157." Enrolment 42 ESTIMATED, listed completion March 2016, overall status UNKNOWN, no results posted. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT02637284
- Hudson Biotech (2026). BPC 157 for Acute Hamstring Muscle Strain Repair (BPC-HAMSTR), NCT07437547 — phase 2, RECRUITING, target enrolment 120, started 2 February 2026, estimated completion 17 February 2028. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT07437547
- Falutz J, Allas S, Blot K, et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 357(23):2359-70 — visceral adipose tissue −15.2% on tesamorelin against +5.0% on placebo, 412 patients, 26 weeks. https://pubmed.ncbi.nlm.nih.gov/18057338/
- Theratechnologies (2026). TH9507 in Patients With HIV-Associated Lipodystrophy, NCT00123253 — phase 3, completed, enrolment 412 actual; conditions HIV infections and lipodystrophy; ran June 2005 to April 2007. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT00123253
- Theratechnologies Inc. (2026). EGRIFTA WR (tesamorelin) for injection — prescribing information, Indications and Usage: "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy"; Limitations of Use: "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect." Read 2026-08-09. DailyMed (US National Library of Medicine), SPL setid 839334d3-8c1d-4c26-9036-2ab524a6ea75. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- Baker LD, Barsness SM, Borson S, et al. (2012). Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Archives of Neurology 69(11):1420-9 — the 20-week randomised trial Marek's catalogue attributes to The Lancet Healthy Longevity (2021). A PubMed search of that journal for tesamorelin or growth hormone releasing hormone returns 0 records; run 2026-08-09. https://pubmed.ncbi.nlm.nih.gov/22869065/
- Massachusetts General Hospital (2026). Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese, NCT00675506 — official title "Physiologic Effects of Long-Term GHRH1-44 in Abdominal Obesity", phase 2, completed January 2012, enrolment 60 actual. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT00675506
- Stealth BioTherapeutics Inc. (2025). FORZINITY (elamipretide hydrochloride) injection — prescribing information: "FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint." SPL published 12 December 2025; read 2026-08-09. DailyMed (US National Library of Medicine), SPL setid 146bf34c-76f2-48db-ac07-fb29cce2cd75. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=146bf34c-76f2-48db-ac07-fb29cce2cd75
- Stealth BioTherapeutics Inc. (2026). TAZPOWER, NCT03098797 — "A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome Followed by Open-Label Treatment." Registry phase PHASE2/PHASE3, COMPLETED 11 October 2021, enrolment 12 actual. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT03098797
- Stealth BioTherapeutics Inc. (2026). NCT02788747 — "A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction." Completed October 2017, enrolment 71 actual. No elamipretide trial in heart failure with PRESERVED ejection fraction appears in the registry. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT02788747
- Karaa A, Bertini E, Carelli V, et al. (2023). Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 101(3):e238-e252 — 218 randomised; "The study did not meet its primary endpoints assessing changes in the 6MWT and PMMSA total fatigue score"; six-minute-walk difference −3.2 m (95% CI −18.7 to 12.3; p = 0.69). https://pubmed.ncbi.nlm.nih.gov/37268435/
- ConjuChem (2026). A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity, NCT00267527 — "A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks." Enrolment 120, December 2005 to September 2006, status TERMINATED. The only registered trial of CJC-1295 in the registry. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT00267527
- Helsinn Therapeutics (U.S.), Inc. (2026). Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function, NCT01280344 — phase 2 dose-finding, 320 participants, completed May 2014. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT01280344
- Helsinn Therapeutics (U.S.), Inc. (2026). Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus, NCT00672074 — phase 2, 117 participants, completed December 2009. Read 2026-08-09. ClinicalTrials.gov (US National Library of Medicine). https://clinicaltrials.gov/study/NCT00672074
- Teichman SL, Neale A, Lawrence B, et al. (2006). Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. Journal of Clinical Endocrinology & Metabolism 91(3):799-805 — GH up 2- to 10-fold for 6 days or more, IGF-1 up 1.5- to 3-fold for 9-11 days, estimated half-life 5.8-8.1 days. Endpoints are hormone concentrations; no body-composition endpoint was measured. https://pubmed.ncbi.nlm.nih.gov/16352683/
- US Food and Drug Administration, Center for Drug Evaluation and Research (2025). Warning Letter to Empower Clinic Services, LLC dba Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064 — MARCS-CMS 700964, 2 April 2025, following an inspection of 24 September to 4 October 2024. Body: investigators "noted serious deficiencies in your practices for producing drug products, which put patients at risk"; products "intended or expected to be sterile were prepared, packed, or held under insanitary conditions". No close-out date in the datatable as of 2026-08-09. fda.gov warning letter index. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-700964-04022025
- US Food and Drug Administration, Division of Pharmaceutical Quality Operations IV (2021). Warning Letter to AnazaoHealth Corporation, 7465 W. Sunset Road, Suite 1200, Las Vegas, NV 89113 — MARCS-CMS 613214, 18 August 2021, concerning an outsourcing facility registered under section 503B. Note the address: this is a different facility from the Tampa, Florida location named in Marek Health's terms of service, and the letter is attributed here to the corporation and that site only. Read 2026-08-09. fda.gov warning letter index. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anazaohealth-corporation-613214-08182021
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