The FDA’s July 2026 peptide vote: what it means for BPC-157 and TB-500

The FDA PCAC peptide vote of July 23–24, 2026 was an advisory recommendation, not an approval. FDA’s Pharmacy Compounding Advisory Committee voted, by narrow margins, to recommend adding BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon to the 503A bulks list that compounding pharmacies may use, and voted against emideltide (DSIP). FDA’s own reviewers had proposed that none of the seven be listed. None of the seven is FDA-approved, none is on the list yet, and the strongest human evidence for any of them is small, short trials.

Item	Status
US FDA status	None of the seven is an FDA-approved drug or a component of one (FDA briefing documents)
Compounding (503A)	As reported by trade press (FDA has posted no vote summary), PCAC voted 8–6 (1 abstention) for BPC-157, KPV and TB-500 on 2026-07-23; 7–5 for MOTS-c; Semax 8–5 and Epitalon 7–4 (1 abstention) for on 2026-07-24; emideltide 6–7 against. Advisory only: no proposed rule yet, and none is on the 503A bulks list (FDA meeting page)
WADA 2026	BPC-157 (S0), TB-500 (S2) and MOTS-c (S4) are named and prohibited at all times; KPV, Semax, Epitalon and emideltide are not named (WADA list)
Strongest evidence	Human RCT reported only as a meeting abstract (BPC-157, n=53, ulcerative colitis); Animal or Lab only for KPV, TB-500 and MOTS-c (FDA BPC-157 review)
Human trials	3 registered on ClinicalTrials.gov: NCT02637284, NCT07752381, NCT07803250; none has posted results
Next regulatory step	FDA decides whether to accept the votes, then a proposed rule, public comment and a final rule; none announced
Last checked	2026-10-18

What did the FDA PCAC vote on in July 2026?

The FDA meeting page lists seven peptides “being considered for inclusion on the 503A Bulks List”, each for specific uses FDA reviewed. The committee’s voting questions asked, for each peptide, “Should [it] (free base) be placed on the list?” and the same for its acetate salt, so the panel answered 14 questions over four sessions. The tallies below are as reported by STAT News, AJMC and RAPS; FDA has not posted a vote summary.

Peptide (use FDA reviewed)	Reported vote	Outcome
BPC-157 (ulcerative colitis)	8–6, 1 abstention, 2026-07-23	Recommended
KPV (wound healing, inflammatory conditions)	8–6, 1 abstention, 2026-07-23	Recommended
TB-500 (wound healing)	8–6, 1 abstention, 2026-07-23	Recommended
MOTS-c (obesity, osteoporosis)	7–5, 2 abstentions, 2026-07-23	Recommended
Epitalon (insomnia)	7–4 (STAT) or 7–5, 1 abstention (RAPS), 2026-07-24	Recommended
Semax (cerebral ischemia, migraine, trigeminal neuralgia)	8–5, 2026-07-24	Recommended
Emideltide / DSIP (opioid withdrawal, chronic insomnia, narcolepsy)	6–7, 1 abstention, 2026-07-24	Not recommended

Vote totals differ from peptide to peptide because some members sat only for certain topics. The final meeting roster marks several voting and temporary members as “Topics Only”, for example one member for the Semax topic only and another for the BPC-157 topic only. STAT reported that the dissenting panelists “were largely physicians from academic institutions and patient representatives”, and ABC News reported that six of the eight recently appointed members run clinics that offer peptides.

The outcome is notable because it went against FDA staff. The FDA briefing introduction lists 14 proposals, and every one reads that the substance should “NOT be included on the 503A Bulks List”.

What is an FDA advisory committee vote?

An advisory committee is a panel of outside experts that answers questions FDA puts to it. In FDA’s own words on the meeting page, advisory committees “make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.” The Pharmacy Compounding Advisory Committee (PCAC) advises specifically on which bulk drug substances, meaning raw active ingredients, pharmacies may use to compound medicines.

The FDA briefing introduction states that FDA “does not intend to issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized,” and that the final determination “may be affected by issues not discussed at the advisory committee meeting.” A yes vote therefore moves a peptide one step along a process; it does not change what a pharmacy may legally do today.

Why the free base and the salt were voted on separately

FDA’s July 23 presentation explained that when FDA places a substance on the list “and a salt or ester of an active moiety is listed, only that particular salt or ester may be used.” BPC-157 free base and BPC-157 acetate are, in law, two different bulk drug substances. FDA added that “common and company names are highly problematic for experimental substances”, because different molecules can be sold under one name.

Why FDA’s reviewers recommended against all seven

FDA weighs four criteria set by its 2019 rule: physical and chemical characterization, safety, evidence of effectiveness, and historical use in compounding, balanced “on a substance-by-substance basis” (FDA briefing introduction). For every peptide, the reviewers judged the substance not well characterized and the human evidence too thin. The table summarizes what each briefing document found.

Peptide	Human evidence FDA found	Main FDA concern
BPC-157 (15 amino acids)	Five small clinical studies; one UC trial (n=53) only as a 2005 meeting abstract	Immunogenicity; no long-term safety data
KPV (3 amino acids)	None in humans	No human data by any route
TB-500 (7 amino acids)	None in humans	No toxicity studies; failed a lab wound test
MOTS-c (16 amino acids)	None in humans	Rodent data only; molecular targets unknown
Emideltide (9 amino acids)	Small IV studies since 1981; none by the nominated route	Possible addiction risk; hypotension
Epitalon (4 amino acids)	Melatonin studies; none in insomnia	Telomerase activation, theoretical cancer risk
Semax (7 amino acids)	Two small studies, intranasal only	Bleeding risk; no human PK data

The findings still show why these peptides draw interest. For BPC-157, the FDA briefing document notes that animal studies reported it could prevent colonic fistulas, liver lesions and gut lesions in rats [Animal], and a 53-person randomized ulcerative colitis trial reported a larger fall in a disease activity score on BPC-157 than on placebo [Human RCT (n=53), meeting abstract]. FDA judged that abstract “inadequate to support the efficacy and safety” of the treatment because the endpoint, inclusion criteria and statistics were not described, and the between-group difference was not statistically clear. For Semax, the FDA Semax review records that it “is a registered drug in Russia and is available as 0.1% and 1% nasal drops”, and that in rodents it showed neuroprotective, analgesic and antidepressant-like effects [Animal].

For TB-500, the FDA TB-500 review found that TB-500 itself “did not induce wound healing” in a scratch-wound fibroblast culture [Lab], while one of its breakdown products, N-acetylated LKKTE, “appeared to have wound-healing properties in vitro” [Lab]. For MOTS-c, the FDA MOTS-c review notes the peptide “was discovered in 2015” and that its studies were “limited to in-vitro and in-vivo rodent models” [Animal, Lab].

What has to happen before any peptide is on the 503A list?

A 503A pharmacy may compound from a bulk ingredient only if it has a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list (FDA 503A bulks page). The seven peptides meet none of these today: each briefing document states there is no USP monograph and that neither form is a component of an approved drug. The list itself is built only “through notice-and-comment rulemaking”. The FDA page records that a February 2019 final rule placed six substances on the list, and a September 2019 proposed rule proposed five more and rejected 26. For a different look at what each pathway allows, see our explainer on 503A vs 503B peptides.

For any of the six recommended peptides, the remaining steps are:

1. FDA decision. FDA reviews the votes, the docket comments and its own reviews, and decides whether to propose listing. It is not bound by the committee.
2. Proposed rule. FDA publishes a proposed rule in the Federal Register naming each substance and salt form.
3. Public comment. Anyone may comment; law firm Orrick estimated comment periods of 60–90 days and the whole process at 12 to 24 months.
4. Final rule. Only when a final rule is published does the substance join the list in 21 CFR 216.23.

As of 2026-10-04, a search of the Federal Register found no proposed rule for any of the seven peptides, and 21 CFR 216.23 still lists only the six substances added in 2019. The pharmacists’ trade group NCPA summarized the same point: pharmacies “will not be permitted to compound them until the final rulemaking is in place”.

Where the Category 2 withdrawal fits

Before the meeting, all seven peptides had already moved off FDA’s safety-risk list. The FDA Category 2 page lists BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon and emideltide under “Bulk drug substances nominated but withdrawn”, which it describes as substances “previously in category 2 of the interim policies” that “were withdrawn by the nominators.” Withdrawal is not a move to Category 1. The FDA 503A page adds that FDA “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.” The background is covered in our guide to Category 1 vs Category 2 peptides.

Where each peptide stands now

The tracker below records the status of each reviewed peptide after the meeting. Our entries for BPC-157, TB-500, KPV and MOTS-c cover the research in full.

Peptide	503A status (checked 2026-10-04)	WADA 2026
BPC-157	PCAC for; not listed; no proposed rule	Prohibited, S0
KPV	PCAC for; not listed; no proposed rule	Not named
TB-500	PCAC for; not listed; no proposed rule	Prohibited, S2.3
MOTS-c	PCAC for; not listed; no proposed rule	Prohibited, S4.4.1
Epitalon	PCAC for; not listed; no proposed rule	Not named
Semax	PCAC for; not listed; no proposed rule	Not named
Emideltide (DSIP)	PCAC against; not listed	Not named

Law firm Orrick reported that a second PCAC meeting is expected before the end of February 2027 to review LL-37, GHK-Cu, dihexa acetate, Melanotan II and PEG-MGF. No notice for that meeting had appeared in the Federal Register by 2026-10-04.

What the vote means for athletes

A compounding recommendation does not change anti-doping rules. The WADA 2026 Prohibited List, in effect from 1 January 2026, names BPC-157 in class S0 (non-approved substances), “Thymosin-ß4 and its derivatives e.g. TB-500” in class S2.3 (growth factors), and MOTS-c in class S4.4.1 (metabolic modulators); all three classes are prohibited at all times. USADA states that BPC-157 is prohibited under S0 and “not approved for human clinical use” by FDA “or any other global health authority”. KPV, Epitalon and emideltide are not named on the list, but S0 covers any pharmacological substance not addressed elsewhere on the list and “with no current approval by any governmental regulatory health authority for human therapeutic use”. Semax is registered in Russia, so whether S0 reaches it is a question for the anti-doping agencies. Our page on WADA banned peptides tracks the list.

Side effects and safety concerns FDA raised

The safety record for all seven is thin rather than alarming: few people have been studied, so harms are unknown more than they are documented.

• Immunogenicity: injected peptides may trigger immune reactions, “potentially amplified by aggregation as well as potential peptide-related impurities,” FDA wrote of BPC-157 (FDA BPC-157 review). The same concern appears in the TB-500, Epitalon and Semax reviews [theoretical, regulator assessment].
• BPC-157 reports: no serious adverse events were reported in the five small studies; headache and flatulence were the most frequent effects after enemas in healthy volunteers [Human, small studies]. FDA’s adverse-event database search through December 4, 2025 found three reports, all with injected BPC-157: injection-site redness and swelling, shortness of breath leading to an emergency visit, and skin and gum darkening that recurred on re-use of a BPC-157 and TB-500 product labeled “research purposes only” [case reports; causality unclear].
• Emideltide: in opioid-withdrawal studies, transient headache, nausea and vertigo were common, with cases of low blood pressure; in one 1984 study, 95 of 107 people had no significant adverse events (FDA July 24 slides) [Human, uncontrolled].
• Epitalon: FDA noted it activates telomerase and lengthens telomeres, and “longer telomeres are generally associated with increased risk for cancer” (FDA Epitalon review) [theoretical].
• Semax: possible anti-thrombotic effects raise “concern about the risk of bleeding”, and in mice it potentiated amphetamine-induced dopamine release (FDA Semax review) [Animal, theoretical].

Products sold outside pharmacies add a separate risk: identity and purity are unverified. At the meeting an FDA quality official asked what form patients actually receive from a TB-500 prescription, as ABC News reported, and the BPC-157 case report above involved a product labeled for research only. Our explainer on research use only peptides covers what that label means.