In July 2026 the United States Food and Drug Administration published substance-by-substance review documents for seven peptides, ahead of a meeting of its Pharmacy Compounding Advisory Committee. Several of those peptides are in our catalogue. The documents are unusually direct about what human evidence exists for each one, and in most cases the answer is less than the surrounding commentary implies.
We think a supplier should publish that rather than wait to be asked. This article sets out what the FDA reviews found, adds the two compounds with the strongest human trial records for contrast, and separates four things that routinely get run together: whether a compound is authorised somewhere, what its label says, whether human trials exist, and whether those trials were any good.
The short answer
- These are review documents, not final policy. They are FDA evaluations with proposed recommendations prepared for an advisory committee; we did not verify the committee’s vote or any final decision.
- For KPV, FDA states it identified no clinical studies or human exposure data at all, and found no case reports of human use.
- For MOTS-c, FDA states the non-clinical work is limited to rodent models and that safety risks in humans are therefore unknown.
- BPC-157 does have human studies — FDA identified five — but the strongest design exists only as a meeting abstract, which FDA calls inadequate.
- Epitalon also has human studies, three by FDA’s count, with blinding unspecified in the strongest and surrogate rather than clinical endpoints.
- For Semax, FDA excluded the Russian-language literature because full English versions were unavailable, and found the remainder insufficient.
- Two compounds we sell have genuinely substantial trial records: ARA-290 and thymosin alpha-1 — and neither result is as clean as it first looks.
- Health Canada’s April 2026 advisory tells consumers not to use products labelled for research use only. We quote it in full below.
The FDA July 2026 peptide reviews
Pharmacy Compounding Advisory Committee · 23–24 July 2026 · bulk drug substance nominations
- What they are
- FDA review documents evaluating peptides nominated for a compounding bulk substances list, prepared for an advisory committee meeting
- Compounds covered
- BPC-157, KPV, TB-500, MOTS-c, DSIP (as emideltide), Semax and Epitalon
- Status
- Reviews with proposed recommendations. We did not verify the committee’s vote or any final listing decision
- Why they are useful
- They are regulator-authored summaries of what human data exists, compound by compound, with the gaps stated
- Strongest trial records we found
- ARA-290 (phase 2b, 64 participants) and thymosin alpha-1 (multicentre, 361 analysed)
- Canadian advisory
- Health Canada RA-81874, 9 April 2026, naming seized unauthorized injectable peptide drugs
- What none of this establishes
- That any of these compounds is suitable for use in people. All are sold here as laboratory reagents
What the documents let you distinguish
- Whether a compound is authorised anywhere
- What its label says
- Whether human trials exist
- Whether those trials were adequate
Four separate questions. Most writing about research peptides collapses them into one, in both directions.
What these documents are
FDA’s Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026. Ahead of that meeting, FDA published review documents for a set of substances that had been nominated for inclusion on a list of bulk drug substances usable in compounding. Seven of those substances are peptides: BPC-157, KPV, TB-500, MOTS-c, DSIP under the name emideltide, Semax and Epitalon.
Two things make them worth reading. They are written by a regulator rather than by a party with a commercial interest, and their format requires FDA to state what evidence it located and what it did not. That makes them a far better source on the state of the human literature than any vendor page, including ours.
An important limit, stated up front. These are review and briefing documents carrying FDA’s proposed recommendations to an advisory committee. They are not final agency policy. We did not verify how the committee voted, and we did not verify whether any final listing decision has been made. Everything below should be read as “this is what FDA’s reviewers wrote in July 2026”, not as “this is settled regulation”.
Where FDA found nothing
For two of the seven, FDA’s answer on human data is simply that there isn’t any.
On KPV, the review states that “the nomination did not include, and FDA has not identified, any clinical studies or human exposure data”, and separately that “we did not find case reports on the use of KPV in humans”. It also records that no published studies were found in which compounded or non-compounded drug products containing KPV had been used. Our own searching, reported in an earlier article on the melanocortin system, reached the same conclusion independently.
On MOTS-c, the review states that “the nomination did not include, and FDA did not identify, information including human exposure data”, that “to date, nonclinical pharmacological studies of MOTS-c have been limited to in-vivo and in-vitro rodent models”, and draws the consequence plainly: “therefore, potential safety risks associated with the use of MOTS-c in humans are unknown”. FDA’s stated proposal was not to add MOTS-c to the list under consideration.
That is about as unambiguous as regulatory prose gets, and it is worth sitting with. These are compounds with substantial cell and animal literatures, extensive mechanistic discussion, and in MOTS-c’s case a well-developed story about mitochondrial signalling. None of that is human data, and the two are not interchangeable.
Where FDA found something thin
For BPC-157 and Epitalon the picture is more interesting, and it corrects something we had previously assumed ourselves.
BPC-157 does have human interventional studies. FDA’s review identified five clinical studies, describing them as short and small, together with a registered phase 1 study for which no results have been posted and no publication located. The strongest design among them was a randomised, double-blind, placebo-controlled trial in ulcerative colitis — but it is available only as a meeting abstract. FDA’s verdict on it is direct: “the data presented for this study are therefore inadequate to support the efficacy and safety of BPC-157”, and “at the time of this evaluation, the data available do not support the use of BPC-157 for the treatment of UC”. FDA also records that it found no studies administering BPC-157 to humans by any of the routes proposed in the nomination, and no human pharmacokinetic data for them.
That sits alongside a 2025 systematic review in the HSS Journal covering BPC-157 in orthopaedic sports medicine, which identified 544 articles from 1993 to 2024 and, after removing duplicates, included 36 studies — “35 preclinical studies, 1 clinical study”. The single clinical study there was retrospective, and the review ran no meta-analysis. The two sources are not in conflict; they used different inclusion criteria, which is why one counts five clinical studies and the other one.
Epitalon likewise has human studies: FDA identified three, two in night-shift workers and one in patients with retinitis pigmentosa. FDA describes the strongest as a randomised, placebo-controlled study in 75 healthy women, and then lists its limitations — “the publication did not specify blinding”, short duration, small sample, no sleep outcomes evaluated despite the context, melatonin-related markers rather than clinical outcomes, and no compounded formulation used. FDA’s overall conclusions were that its search “did not retrieve publications discussing efficacy” for the nominated use, that it “has not identified clinical studies assessing the safety” of these substances in humans, that there are “no clinical data to support the safety”, and that “a balancing of the criteria weighs against” listing. We could not independently locate the 2021 study FDA describes, so we are reporting FDA’s characterisation of it and not treating it as something we have read.
The language problem
Semax illustrates a difficulty that is easy to miss and that cuts both ways.
FDA’s review located six references plus two nominator submissions. Three of those were meeting abstracts, and for one FDA notes that “no full published article could be located for this reference”. Of a migraine and neuralgia study it observes “the small sample size, no blinding, no control group”. It found no human pharmacokinetic studies and no published human case reports, and concluded there was “insufficient evidence to support the effectiveness for semax” for the nominated uses. FDA also records, matter-of-factly, that “Semax is a registered drug in Russia”.
The complication is in how that review was bounded. Many of the references were in Russian, and FDA states that “these references were not considered as part of this evaluation” because full English versions were unavailable. So FDA’s conclusion is accurate about the literature FDA could assess, and it is not a statement that no Russian-language evidence exists.
Separately, we located a 2018 paper in a Russian neurology and psychiatry journal, indexed as a clinical trial, reporting plasma BDNF in 110 patients after ischaemic stroke, with subgroups receiving Semax or not. Two cautions belong with it. Its abstract does not state that allocation was randomised and does not describe a placebo control, so it should not be called a randomised controlled trial. And it does not appear among the studies FDA evaluated. The honest summary is that the Semax literature is real, substantially Russian-language, largely unreplicated in indexes FDA will accept, and weaker in design than the word “trial” suggests. Our guide to reading a peptide study covers how much design detail changes what a result means.
The two with real trial records
For contrast, two compounds in our catalogue have human trial records that are genuinely substantial. Neither is as clean as a headline would make it.
ARA-290, also called cibinetide. A 2017 paper in Investigative Ophthalmology and Visual Science reports a phase 2b, 28-day, randomised, placebo-controlled study in 64 participants with sarcoidosis-associated small nerve fibre loss and neuropathic pain, across three active arms and placebo. The authors state that “the primary study endpoint was a change in CNFA at 28 days” — corneal nerve fibre area. The placebo-corrected results were 109 for the lowest-dose arm with a confidence interval spanning zero, 697 for the middle arm with a confidence interval of 159 to 1236 and P = 0.012, and 431 for the highest arm, again spanning zero. So the middle arm met significance and the lowest and highest did not, which is a non-monotonic pattern rather than a dose-response. Pain improved in all groups, placebo included.
Thymosin alpha-1. The best-documented trial we could verify is ETASS, published in Critical Care in 2013: a prospective, randomised, controlled study across six tertiary intensive care units in China, with 367 randomised and 361 analysed. “The primary outcome was death from any cause and was assessed 28 days after enrollment.” Twenty-eight-day all-cause mortality was 26.0 per cent against 35.0 per cent, a relative risk of 0.74 with a confidence interval of 0.54 to 1.02; the non-stratified analysis gave P = 0.062 and a log-rank test gave P = 0.049. It was single-blind, the authors noting that no identical-looking placebo was available. A result that straddles significance depending on the test chosen should be reported that way.
On thymosin alpha-1’s regulatory position, FDA’s own briefing document is worth quoting because the claims made for it elsewhere are looser: “FDA has approved no drug products containing Ta1”, and it “is not approved in the United States, Japan, or Europe (except Italy)”. FDA notes a company report claiming approvals across several regions and says it “is unable to independently verify these claims of approval in all the specified countries”. Across the twelve uses it evaluated, FDA’s conclusion was a “lack of evidence to support the effectiveness”. Orphan-drug designations exist for thymalfasin, but a designation is not an approval, and the FDA record we read lists the status as not approved for the orphan indication.
Four things that get conflated
The reason this material is so often misread is that four separate facts travel under one heading.
| Question | What answers it | Worked example |
|---|---|---|
| Is it authorised as a medicine somewhere? | A regulator’s product register | Thymosin alpha-1: no approved product in the US per FDA, which names Italy as an exception in Europe |
| What does the label say? | The packaging and the seller’s documentation | “For research use only” is a statement about how a product is supplied, not a finding about its literature |
| Do human trials exist? | The published and indexed literature | KPV and MOTS-c: none identified by FDA. BPC-157 and Epitalon: some, by FDA’s count |
| Were those trials adequate? | Design, size, blinding, endpoints, publication status | BPC-157’s strongest design is an abstract; Epitalon’s does not specify blinding; ETASS straddles significance |
Both directions of error are common. “It’s research use only, so nothing has ever been tested” is wrong for ARA-290 and thymosin alpha-1. “There are human studies, so it works” is wrong for BPC-157, where the strongest study was never published in full and the regulator calls the data inadequate. Our articles on clinical trial phases and systematic reviews versus meta-analyses cover the machinery for telling these apart, and research grade versus pharmaceutical grade covers what the label does and does not assert.
The Canadian advisory
None of the above is the Canadian position, and Canadian buyers should know what that is. On 9 April 2026 Health Canada published advisory RA-81874, titled “Think twice before injecting peptides bought online: unauthorized products can seriously harm you”.
The advisory records that “Health Canada has seized several unauthorized injectable peptide drugs and is working with the Canada Border Services Agency” to stop unauthorized shipments entering the country, and lists examples of the products seized. Among the peptides named are BPC-157, CJC-1295, DSIP, Epitalon, GHK-Cu, HCG, ipamorelin, KPV, Melanotan I and II, MOTS-c, NAD+, SS-31, TB-500 and retatrutide.
Its instruction to consumers is explicit, and we quote it rather than paraphrase: “Do not buy or use unauthorized drugs.” and “Do not use drugs that are labelled “For Research Use Only – Not for Human Consumption”.” followed by “These can be dangerous to your health.” The advisory also directs readers to check for an eight-digit Drug Identification Number, noting that “authorized prescription drugs in Canada have an eight-digit Drug Identification Number (DIN)”, and to verify it in Health Canada’s Drug Product Database.
We sell laboratory reagents for in-vitro research, and that advisory is the reason the research-use-only framing on every page here is not a formality. Our article on whether research peptides are legal in Canada covers the regulatory structure in more detail.
What’s established and what isn’t
Reasonably well established
- FDA published substance review documents for seven peptides in July 2026, ahead of an advisory committee meeting.
- For KPV, FDA identified no clinical studies or human exposure data, and no case reports of human use.
- For MOTS-c, FDA stated the non-clinical work is limited to rodent models and that human safety risks are unknown.
- BPC-157 has human studies; FDA identified five, and judged the strongest, an abstract-only trial, inadequate.
- A 2025 systematic review of BPC-157 in orthopaedic sports medicine included 36 studies, 35 preclinical and 1 clinical, with no meta-analysis.
- ARA-290 was studied in a 64-participant phase 2b randomised placebo-controlled trial with a stated primary endpoint.
- Thymosin alpha-1 was studied in a 361-participant multicentre randomised trial with 28-day all-cause mortality as the primary outcome.
- Health Canada advisory RA-81874, dated 9 April 2026, names seized unauthorized injectable peptide drugs and instructs consumers not to use products labelled for research use only.
Open questions
- How the advisory committee voted, and whether any final listing decision has been made. Not verified.
- What the Russian-language Semax literature contains. FDA excluded it; we could not assess it either.
- What the 2021 Epitalon study actually reports. We could not locate it independently and rely on FDA’s description.
- Whether ARA-290’s non-monotonic result reflects a real effect, given that only the middle arm reached significance and placebo improved on the pain measure.
- Whether thymosin alpha-1’s mortality signal would survive a double-blind replication, given the single-blind design and a primary result that straddles significance.
- The human evidence position for GHK-Cu, CJC-1295, ipamorelin, TB-500, DSIP and retatrutide. We did not assess those here and this article should not be read as covering them.
What this means for sourcing
None of this changes what a research buyer should be checking, but it does sharpen why.
- Judge documentation, not narrative. What a supplier can prove about a batch’s identity and purity is a separate question from what the compound does, and only the first is within a supplier’s gift to demonstrate. Our COA guide covers the first.
- Treat mechanism as mechanism. An extensive pathway literature is not human evidence, and the FDA reviews are a useful corrective for compounds where the two get blurred.
- Prefer suppliers who cite regulators. A page that reproduces what FDA or Health Canada actually wrote is checkable. A page that asserts outcomes is not.
- Read the research-use-only line as what it is. It describes how the product is supplied and the terms on which it is sold, and it is not a comment on any literature.
Compounds discussed in this article
These are the catalogue items covered above. The descriptions below state the evidence position discussed in this article and nothing beyond it; Janoshik Analytical certificates for most research products are listed by batch on our Lab Testing page, and the rest are available on request.
BPC-157FDA identified five small clinical studies; the strongest is an abstractView product
KPVFDA identified no clinical studies or human exposure dataView product
MOTS-cFDA states non-clinical work is limited to rodent modelsView product
ARA-290 (Cibinetide)Studied in a 64-participant phase 2b randomised trialView product
Research use only. Pure Peptides Canada products are laboratory reagents for in-vitro research, not for human or veterinary use. This article explains published research for education; it is not medical, dietary or dosing guidance.
Frequently asked questions
What are the FDA’s July 2026 peptide reviews?
They are substance-by-substance review documents that FDA published ahead of a Pharmacy Compounding Advisory Committee meeting held on 23 and 24 July 2026, covering peptides nominated for a compounding bulk drug substances list. Seven are peptides: BPC-157, KPV, TB-500, MOTS-c, DSIP under the name emideltide, Semax and Epitalon. They are valuable because the format obliges FDA to state what evidence it located and what it did not. They are review documents with proposed recommendations, not final agency policy, and we did not verify the committee’s vote or any final decision.
Does KPV have any human data?
Not according to FDA’s review. The document states that the nomination did not include, and FDA has not identified, any clinical studies or human exposure data, and separately that FDA did not find case reports on the use of KPV in humans. It also records that no published studies were found in which drug products containing KPV had been used. Our own independent searching reached the same conclusion. KPV does have a cell and animal literature, but that is a different thing from human data.
Has BPC-157 been tested in people?
Yes, which corrects a common assumption in both directions. FDA’s review identified five clinical studies, describing them as short and small, plus a registered phase 1 study with no posted results and no located publication. The strongest design was a randomised, double-blind, placebo-controlled trial in ulcerative colitis, but it exists only as a meeting abstract, and FDA’s assessment is that the data presented are inadequate to support efficacy and safety. FDA also found no studies using any of the routes proposed in the nomination, and no human pharmacokinetic data for them.
Why do two sources disagree on how many BPC-157 clinical studies exist?
Because they used different inclusion criteria, not because either is wrong. FDA’s review counted five clinical studies. A 2025 systematic review in the HSS Journal, scoped to orthopaedic sports medicine, identified 544 articles from 1993 to 2024 and after removing duplicates included 36 studies, of which 35 were preclinical and 1 was clinical, that one being retrospective. A review restricted to one clinical field and one study-design filter will count differently from a regulatory evaluation surveying all nominated uses.
Which compounds here have the strongest human trial records?
ARA-290 and thymosin alpha-1, and both come with caveats worth stating. ARA-290 was studied in a 28-day phase 2b randomised placebo-controlled trial in 64 participants with a stated primary endpoint, in which the middle active arm reached significance while the lowest and highest arms did not, and pain improved in all groups including placebo. Thymosin alpha-1 was studied in a 361-participant multicentre randomised trial with 28-day all-cause mortality as the primary outcome, which was single-blind and whose primary result gave P equal to 0.062 on the non-stratified analysis and 0.049 on a log-rank test.
Is thymosin alpha-1 an approved medicine?
Not in the United States. FDA’s own briefing document states that FDA has approved no drug products containing it, and that it is not approved in the United States, Japan or Europe with the exception of Italy. FDA notes a company report claiming approvals in several other regions and says it is unable to independently verify those claims. Orphan-drug designations exist for thymalfasin, but a designation is not an approval, and the record we read lists the status as not approved for the orphan indication. Across the twelve uses FDA evaluated, its conclusion was a lack of evidence to support effectiveness.
What does Health Canada say about research-use-only peptides?
Health Canada published advisory RA-81874 on 9 April 2026. It records that Health Canada has seized several unauthorized injectable peptide drugs and is working with the Canada Border Services Agency to stop unauthorized shipments entering the country, and it names examples including BPC-157, CJC-1295, DSIP, Epitalon, GHK-Cu, HCG, ipamorelin, KPV, Melanotan I and II, MOTS-c, NAD+, SS-31, TB-500 and retatrutide. Its instruction is explicit: do not buy or use unauthorized drugs, and do not use drugs labelled for research use only and not for human consumption, because these can be dangerous to health. It also directs readers to check for an eight-digit Drug Identification Number.
Documentation you can check, for research use
Laboratory reagents priced in Canadian dollars and shipped tracked from inside Canada, with Janoshik Analytical certificates for most products listed by batch and the rest available on request.
References
- US Food and Drug Administration. July 23–24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. Meeting materials and substance review documents. Meeting page
- US Food and Drug Administration. BPC-157 review document prepared for the Pharmacy Compounding Advisory Committee, July 2026. Document
- US Food and Drug Administration. KPV review document prepared for the Pharmacy Compounding Advisory Committee, July 2026. Document
- US Food and Drug Administration. MOTS-c review document prepared for the Pharmacy Compounding Advisory Committee, July 2026. Document
- US Food and Drug Administration. Epitalon review document prepared for the Pharmacy Compounding Advisory Committee, July 2026. Document
- US Food and Drug Administration. Semax review document prepared for the Pharmacy Compounding Advisory Committee, July 2026. Document
- US Food and Drug Administration. Thymosin Alpha-1 (Ta1) Related Bulk Drug Substances, briefing document. Document
- Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal. 2025;21(4):485–495. DOI
- Culver DA, Dahan A, Bajorunas D, et al. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain. Invest Ophthalmol Vis Sci. 2017;58(6):BIO52–BIO60. Abstract consulted. DOI
- Wu J, Zhou L, Liu J, et al. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013;17(1):R8. Abstract and methods consulted. DOI
- Health Canada. Think twice before injecting peptides bought online: unauthorized products can seriously harm you. Advisory RA-81874, 9 April 2026. Advisory
- The efficacy of semax in the treatment of patients at different stages of ischemic stroke. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2018;118(3, Vyp. 2):61–68. Russian language; abstract and indexing consulted. DOI
For laboratory research use only. Not for human or veterinary use. This article summarizes published research for educational purposes and is not medical advice.
