FDA PCAC 2026: April 29 Mid-Cycle Status Update

Where the 12-peptide Pharmacy Compounding Advisory Committee review stands fourteen days after the April 15 Federal Register notice. Eighty-five days to the Day 1 vote, seventy-one days to the public-comment cutoff.

Last updated: April 29, 2026

The FDA's PCAC 2026 review is now in the public-docket phase. The April 15, 2026 Federal Register notice (2026-07361) opened docket FDA-2025-N-6895 and locked in the July 23-24, 2026 Day 1 / Day 2 meeting schedule. A second meeting before the end of February 2027 is scheduled to handle the remaining five peptides. As of April 29, no agency briefing materials have been published, no compound sponsors have publicly registered for oral presentations, and the docket has not yet drawn the volume of public comment that typically arrives in the final two weeks before the cutoff.

Day 1 — July 23, 2026: Where Each Compound Stands

Four peptides under review on Day 1, each evaluated for a specific indication FDA has identified in the docket. None of these has a registered Phase 3 trial that would qualify for an NDA pathway; the PCAC track is the compounding-pharmacy alternative.

• BPC-157 — evaluated for ulcerative colitis. The 2025 Vasireddi systematic review screened 544 published articles and found one human clinical study meeting full inclusion criteria. Predominantly preclinical evidence base; WADA-banned (S0, 2022).
• KPV — evaluated for wound healing and inflammatory conditions. The α-MSH C-terminal tripeptide; small published evidence base, mostly preclinical models of colitis and topical wound repair.
• TB-500 — evaluated for wound healing. Recombinant N-terminal fragment of thymosin beta-4; preclinical data on actin-binding and cell migration; one small Phase 1 study (RegeneRx).
• MOTs-C — evaluated for obesity and osteoporosis. Mitochondrial-derived peptide; metabolic and bone-density signals in preclinical models; one small human exploratory study.

Day 2 — July 24, 2026: Where Each Compound Stands

Three peptides under review on Day 2. Two of them — Semax and Epitalon — have decades of Russian-language clinical literature that does not translate cleanly into Western evidence-grading frameworks, which is likely to be a focus of committee discussion.

• Emideltide (DSIP) — evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. Delta sleep-inducing peptide; mid-1970s isolation; small human studies in sleep and stress contexts.
• Semax — evaluated for cerebral ischemia, migraine, and trigeminal neuralgia. ACTH(4-10) analog; Russian Pharmacopoeia-listed since 1996; primary evidence base is Russian-language clinical literature.
• Epitalon — evaluated for insomnia. Pineal-gland tetrapeptide; primary evidence from Khavinson group at the St. Petersburg Institute of Bioregulation; human telomere-length and longevity claims do not have independent Western replication.

Second Meeting (Before End of February 2027): Where Each Compound Stands

Five peptides scheduled for the second PCAC meeting. The exact date is not yet announced — FDA typically confirms the second meeting roughly 90 days in advance.

• GHK-Cu — copper-binding tripeptide; oldest of the cohort (isolated 1973). Primary evidence base is dermatologic; topical formulations are already FDA-regulated as cosmetics.
• Melanotan II — synthetic α-MSH analog; melanocortin receptor agonist; significant adverse-event signal in the literature (priapism, melanoma case reports, hypertension).
• Cathelicidin (LL-37) — endogenous human antimicrobial peptide; preclinical antimicrobial and immunomodulatory data; minimal published human therapeutic-use data.
• Dihexa acetate — angiotensin IV-derived peptidomimetic; foundational 2014 mechanism paper (Benoist et al., PMID 25187433) retracted in April 2025; clinical analog fosgonimeton failed LIFT-AD in late 2024.
• PEG-MGF — pegylated mechano growth factor (IGF-1Ec splice variant); athletic-performance literature is largely from non-peer-reviewed sources; preclinical muscle-repair data exists but is limited.

Public Comment: What Has Arrived So Far

Docket FDA-2025-N-6895 is open for written comment through July 22, 2026, 11:59 PM ET. Comments received on or before July 9, 2026 are forwarded to the committee for the July meeting; comments after July 9 are received by FDA but are not given to committee members for the July session. As of April 29, the docket has not yet attracted the volume of comment that compounding-pharmacy notices typically draw in the final two weeks. Industry sponsors (compounding-pharmacy associations, academic researchers, peptide manufacturers) tend to file in waves: an early academic wave around the 60-day mark, a sponsor wave around the 30-day mark, and a clinical-society wave in the final week.

Oral-presentation registration closes June 30, 2026 — slots are limited and FDA selects requesters based on relevance and balance of viewpoints. Anyone wishing to present in person or remotely must register through the meeting page on FDA's advisory-committee calendar.

Submit a comment to the docket →

PCAC + PCAC Stack Pages

Several of the 12 peptides under review are commonly co-administered. The Stack Research Tool covers the published co-administration literature for these pairings — informational only, not a recommendation.

Open Stack Research Tool — pair any two of 113 compounds →

What to Watch Between Now and July 23

The procedurally meaningful events between this update and the Day 1 meeting are: (1) June 30, 2026 — oral-presentation registration cutoff. The list of confirmed oral presenters typically posts in the first week of July and tells you which sponsors and clinical groups intend to defend or oppose specific compounds. (2) July 9, 2026 — written-comment cutoff for committee distribution. Comment volume and stakeholder balance become visible in the final week before the cutoff. (3) ~July 21, 2026 — FDA briefing-materials release. FDA typically posts agency briefing documents two business days before the meeting; these materials usually include the agency's evidence summaries, prior PCAC-vote history for related substances, and the specific questions that will be put to the committee.

For full meeting logistics, primary-source links, and per-compound profile pages, see the main FDA PCAC 2026 tracker.

Kalios is an independent reference. We take no position for or against any peptide's inclusion on the 503A Bulks List. This update reflects the public state of the docket as of April 29, 2026 and will be superseded by subsequent updates as the docket moves and primary sources publish new material. None of the statements on this page constitute medical, legal, or regulatory advice. Always consult a licensed healthcare provider before considering any research peptide.