Peptide news is dominated by vendors announcing that something was “approved” when it was not. This page tracks the primary record: Federal Register notices, FDA briefing documents, advisory committee votes and approval letters — with the distinction between them kept intact.
1. Removal from Category 2 — means a nomination was withdrawn, not that compounding is allowed. 2. A PCAC recommendation — advisory, non-binding, and the FDA can reject it. 3. Placement on the 503A list after notice-and-comment rulemaking — the only step that changes what is legal. As of today, no peptide reviewed in July 2026 has reached step three.
Record verified against primary sources on 13 September 2026.
Five developments, in the order they matter. Regulatory status and evidence are separate questions, and neither is a recommendation.
Letters dated 24 August, posted 1 September, went to Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations trading as Tex Peptides, under the heading “Unapproved New Drugs/Misbranded.” Products named across the letters include semaglutide, tirzepatide, retatrutide, survodutide, mazdutide, SS-31, PT-141, tesamorelin, ipamorelin blends and bacteriostatic water sold for reconstitution.
Why it matters: the agency held that “research use only” and “not for human consumption” labelling did not settle the question. It read the websites as a whole — including reconstitution supplies and preparation guides sold alongside the vials — as evidence the products were intended as drugs for human use. A disclaimer is not a shield if the surrounding marketing points the other way.
The company said it intends to submit a Biologics License Application in the first quarter of 2027, superseding earlier guidance of a 2026 submission, and cited time needed for manufacturing and quality data. TRIUMPH-1, -2 and -3 have now reported.
The FDA takes roughly 60 days to decide whether to accept a filing, then 6–10 months to review. That places the earliest realistic decision in late 2027 or the first half of 2028. Retatrutide remains investigational and is not prescribable outside a trial or a limited expanded-access programme.
BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax received favourable PCAC votes in July; emideltide (DSIP) did not. Those recommendations are advisory. None of the six appears in 21 CFR 216.23, the FDA has issued no final determination, and a proposed rule with a public comment period must come before any final rule.
The committee is scheduled to meet again before the end of February 2027 on five further substances: GHK-Cu, Melanotan II, cathelicidin (LL-37), dihexa acetate and pegylated mechano growth factor (PEG-MGF).
Novo Nordisk submitted its application on 18 December 2025 for chronic weight management. Company guidance points to a decision in the fourth quarter of 2026, consistent with a standard ten-to-twelve-month review. No PDUFA date has been publicly confirmed. Not approved.
Coverage this month carried researchers saying the evidence that these compounds work is, in plain terms, not there — published alongside the warning-letter sweep and reporting on patients hospitalised after taking unapproved and compounded GLP-1 products.
Nothing on this page changes a grade. A compound moves on our scale when human data moves it, not when a committee votes or a regulator writes a letter.
Compounding status only. This is not the same as FDA approval, and none of these are approved drugs.
Status: Investigational — phase 3 (TRIUMPH)
Not approved anywhere. Lilly said on 23 July 2026 it plans to file in Q1 2027; earliest realistic decision late 2027 to mid 2028.
Status: NDA filed 18 Dec 2025
FDA decision anticipated late 2026. Not approved.
Status: FDA-approved 1 April 2026
Prescribable. A small molecule, not a peptide.
Status: FDA accelerated approval 19 Sept 2025
Approved for muscle strength in Barth syndrome only, on an intermediate endpoint.
Status: Category 2 (2023) → PCAC recommended 23 Jul 2026, 8-6
Not compoundable. Rulemaking required.
Status: Category 2 (2023) → PCAC recommended 23 Jul 2026, 8-6
Not compoundable. Rulemaking required.
Status: PCAC recommended 23 Jul 2026, 8-6
Not compoundable. Rulemaking required.
Status: PCAC recommended 23 Jul 2026, 7-5
Not compoundable. Rulemaking required.
Status: PCAC recommended 24 Jul 2026, 8-5
Not compoundable in the US. Registered medicine in Russia.
Status: PCAC recommended 24 Jul 2026, 7-5
Not compoundable. Rulemaking required.
Status: PCAC voted AGAINST, 24 Jul 2026, 6-7
Nomination effectively ended for this cycle.
Status: Category 1 with limitations (2023); further PCAC review due before Mar 2027
Permitted within stated limitations.
Status: Category 1
One of the very few peptides FDA placed in Category 1.
Status: Removed from Category 2, Sept 2024 (nominations withdrawn)
No lawful 503A compounding basis. Removal is not approval.
Status: PCAC review scheduled before end of Feb 2027
Not compoundable pending review.
Lilly reported TRIUMPH-2 met its primary endpoint. It follows TRIUMPH-1 in May and TRIUMPH-4 in December 2025. Retatrutide remains investigational and is not prescribable anywhere.
In 2,339 participants, retatrutide produced 17.6%, 23.7% and 25.0% mean weight reduction at 4, 9 and 12 mg versus 3.9% on placebo at 80 weeks. A subgroup escalated to maximum tolerated dose reached about 30% at 104 weeks.
FDA approved Lilly's once-daily tablet for chronic weight management, on the ATTAIN programme of over 4,500 participants. It is not a peptide, which is precisely why it can be swallowed rather than injected.
The first GLP-1 pill cleared for weight loss, on the OASIS-4 trial where adherent participants lost about 16.6% of body weight.
Filed on REDEFINE-1 and REDEFINE-2, with a decision anticipated late 2026 and no public PDUFA date. REDEFINE-4, the head-to-head against tirzepatide, missed its endpoint.
The first successful phase 3 readout for retatrutide, in adults with obesity and knee osteoarthritis. WOMAC pain scores fell by up to 75.8%, with more than one in eight participants free of knee pain at the end.
Industry bodies publicly welcomed the advisory vote while stressing the recommendations are non-binding, do not make the peptides FDA-approved, and do not change what may lawfully be compounded today.
BPC-157, TB-500 and KPV each passed 8-6 with one abstention; MOTS-c 7-5 with two abstentions; Semax 8-5 and Epitalon 7-5. Emideltide (DSIP) was voted down 6-7 — the only rejection. The committee broke with FDA staff on all six.
Briefing documents posted before the meeting concluded the evidence did not support adding any of the seven peptides, citing insufficient safety and effectiveness data and characterisation concerns.
FDA announced the 23-24 July meeting to consider seven peptides, and a further meeting before the end of February 2027 to review GHK-Cu, Melanotan II, cathelicidin (LL-37), dihexa acetate and PEG-MGF.
FDA removed a further group of peptides from Category 2 following nominator withdrawals. Removal from Category 2 is not authorisation to compound — a distinction widely misreported at the time.
The first FDA-approved mitochondria-targeted therapeutic, for muscle strength in Barth syndrome patients over 30 kg. The pivotal TAZPOWER trial randomised 12 patients and missed its primary endpoints; approval rested on knee extensor strength in the open-label extension, with a confirmatory trial ongoing.
AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1 and Selank acetate were removed from Category 2 after their nominators withdrew the nominations.
BPC-157, ipamorelin, kisspeptin-10 and others were designated Category 2 — substances with significant safety risks — barring their use in 503A compounding. GHK-Cu was placed in Category 1 with limitations.
We would rather send you to the primary source than ask you to trust our summary. These are the feeds this page is built from.
The actual list, with each substance's category. The primary document for anything on this page.
Meeting notices, briefing documents and votes. The July 2026 briefing packets are posted here.
Where meeting notices and any eventual rulemaking are published first.
Whether a human trial exists at all — the fastest way to check a vendor's claim.
The literature itself. Filter by 'Clinical Trial' and 'Humans' before believing anything.
Current for anyone who is tested. Several compounds here are prohibited and detectable.