Staff proposed that neither form be added for all seven subjects.
FDA action pendingOfficial record verified
FDA PCAC / July 23–24, 2026Six peptides received favorable recommendations.
FDA has not taken final action.
FDA staff proposed that neither form of any reviewed substance be added to the 503A Bulks List. PCAC returned favorable recommendations on twelve of fourteen form-level questions. This file keeps those positions separate.
Committee recommendations are advisory. They are not FDA drug approvals and did not independently change legal access.
Regulatory stageCommittee advice complete · final FDA determination pending
- 01NominatedComplete
- 02FDA evaluationComplete
- 03PCAC recommendationCurrent record
- 04FDA determinationPending
- 05Proposed ruleIf pursued
- 06Public comment + final ruleIf proposed
Verified vote ledger
Fourteen questions. Every form kept separate.
The tracker is the control layer: filter the complete vote record, inspect the exact tally, then open a peptide dossier for the evidence and editorial analysis behind the result.
Six peptides received favorable outcomes on both questions.
Both Emideltide form-level questions were unfavorable.
No committee vote independently changed legal status.
Outcome
Meeting day
14 of 14 questions
| Peptide | Form | PCAC result | Tally | Vote composition | FDA staff | Record |
|---|---|---|---|---|---|---|
| BPC-157Day 1 · Open dossier | free base | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 04:43:06.628 | |
| BPC-157Day 1 · Open dossier | acetate | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 04:52:49.520 | |
| KPVDay 1 · Open dossier | free base | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 07:06:35.280 | |
| KPVDay 1 · Open dossier | acetate | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 07:14:04.400 | |
| TB-500Day 1 · Open dossier | free base | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 09:48:41.276 | |
| TB-500Day 1 · Open dossier | acetate | Favorable | 8–6–1Yes · No · Abstain · n=15 | Proposed not add | 09:54:13.756 | |
| MOTS-cDay 1 · Open dossier | free base | Favorable | 7–5–2Yes · No · Abstain · n=14 | Proposed not add | 11:33:43.680 | |
| MOTS-cDay 1 · Open dossier | acetate | Favorable | 7–5–2Yes · No · Abstain · n=14 | Proposed not add | 11:38:51.840 | |
| Emideltide (DSIP)Day 2 · Open dossier | free base | Unfavorable | 6–7–1Yes · No · Abstain · n=14 | Proposed not add | 03:15:17.600 | |
| Emideltide (DSIP)Day 2 · Open dossier | acetate | Unfavorable | 6–7–1Yes · No · Abstain · n=14 | Proposed not add | 03:22:37.359 | |
| EpitalonDay 2 · Open dossier | free base | Favorable | 7–4–1Yes · No · Abstain · n=12 | Proposed not add | 04:54:31.680 | |
| EpitalonDay 2 · Open dossier | acetate | Favorable | 7–4–1Yes · No · Abstain · n=12 | Proposed not add | 05:01:31.680 | |
| SemaxDay 2 · Open dossier | free base | Favorable | 8–5–1Yes · No · Abstain · n=14 | Proposed not add | 07:52:36.958 | |
| SemaxDay 2 · Open dossier | acetate | Favorable | 8–5–1Yes · No · Abstain · n=14 | Proposed not add | 08:04:42.558 |
Member-level roll-call ballots
8 ballots captured from the vote boards and the live webcast, showing who voted how. These are a different unit from the fourteen form-level questions above, and do not map one-to-one onto them.
Filter
BPC-157 (free base)
Jul 23, 2026 · 12:39 PM
✓ Recommended
Yes 8No 6Abstain 1
Yes (8)
No (6)
Abstain (1)
BPC-157 (acetate)
Jul 23, 2026 · 12:49 PM
✓ Recommended
Yes 8No 6Abstain 1
Yes (8)
No (6)
Abstain (1)
KPV
Jul 23, 2026 · 3:03 PM
✓ Recommended
Yes 8No 6Abstain 1
Yes (8)
No (6)
Abstain (1)
TB-500
Jul 23, 2026 · 5:45 PM
✓ Recommended
Yes 8No 6Abstain 1
Yes (8)
No (6)
Abstain (1)
MOTS-c
Jul 23, 2026 · 7:30 PM
✓ Recommended
Yes 7No 5Abstain 2
Yes (7)
No (5)
Abstain (2)
Emideltide / DSIP
Jul 24, 2026 · 11:11 AM
Provisional✕ Not recommended
Yes 6No 7Abstain 1
Yes (6)
No (7)
Abstain (1)
Epitalon
Jul 24, 2026 · 12:50 PM
Provisional✓ Recommended
Yes 7No 4Abstain 1
Yes (7)
No (4)
Abstain (1)
Semax
Jul 24, 2026 · 3:50 PM
Provisional✓ Recommended
Yes 8No 5Abstain 1
Yes (8)
No (5)
Costantino Iadecola, MDFriedhelm Sandbrink, MD
Abstain (1)
Every listed member and how they voted on each captured ballot. Support = Yes ÷ (Yes + No); abstentions and not-eligible topics are excluded from the denominator. Y = Yes · N = No · A = Abstain · – = not eligible or not present. Built from the 8 transcribed roll-call ballots.
Industry tiesNamed in media — peptide stakeOwns clinic offering peptidesOther pharma/industry tiesNo commercial peptide ties found
Coalition signal: David Pope, PharmD is the only listed member who cast both Yes and No votes — 7 Yes and 1 No, on Emideltide.
Voting pattern
19 of 19 members
| # | BPC-fb | BPC-ac | KPV | TB-500 | MOTS-c | Emid (provisional) | Epit (provisional) | Semax (provisional) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 01 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 02 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 03 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 04 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 05 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 06 | No opposing votes | Y | Y | Y | Y | A | Y | Y | Y | 7 | 1 | 100% | ||
| 07 | No opposing votes | Y | Y | Y | Y | Y | – | – | Y | 6 | 2 | 100% | ||
| 08 | Split voter | Y | Y | Y | Y | Y | N | Y | Y | 7 | 1 | 88% | ||
| 09 | Costantino Iadecola, MDNo supporting votes | – | – | – | – | – | – | – | N | 1 | 7 | 0% | ||
| 10 | Friedhelm Sandbrink, MDNo supporting votes | – | – | – | – | – | – | – | N | 1 | 7 | 0% | ||
| 11 | No supporting votes | – | – | – | – | – | N | – | – | 1 | 7 | 0% | ||
| 12 | No supporting votes | N | N | – | – | – | – | – | – | 2 | 6 | 0% | ||
| 13 | No supporting votes | – | – | N | N | – | – | – | – | 2 | 6 | 0% | ||
| 14 | No supporting votes | N | N | N | N | N | N | – | – | 6 | 2 | 0% | ||
| 15 | No supporting votes | N | N | N | N | N | N | N | – | 7 | 1 | 0% | ||
| 16 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 17 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 18 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 19 | Abstained throughout | A | A | A | A | A | A | A | A | 8 | — |
How to read this viewThis reproduces the 8 member-level ballots captured from the vote boards. The question ledger retains all fourteen form-level questions. Support is Yes ÷ (Yes + No); abstentions and N/E are excluded from the denominator.
Source boundaryP marks Day 2 ballots labelled provisional by the live source, pending the FDA transcript. N/E means the member was not eligible or not present for that ballot — it is never inferred as a vote.
How to read this tracker
“Favorable” describes the advisory committee’s response to a 503A Bulks List question. It does not mean FDA-approved, proven safe, proven effective or currently legal to compound.
Peptide dossiers
Every result opens into an editorial record.
The tracker tells you what happened. Each dossier explains what FDA evaluated, the strongest evidence signal, the decisive limitation and what remains unresolved.
01Day 1
PCAC favorable
BPC-157
ulcerative colitis
The official record contains a limited human signal and substantial nonclinical literature, but the exact form, dosage form, route, duration and safety questions remain unresolved.
free base8–6–1Y · N · A · n=15
acetate8–6–1Y · N · A · n=15
02Day 1
PCAC favorable
KPV
wound healing · inflammatory conditions
KPV’s official-record case is primarily mechanistic and nonclinical. FDA said it found no human administration or exposure data by any route.
free base8–6–1Y · N · A · n=15
acetate8–6–1Y · N · A · n=15
03Day 1
PCAC favorable
TB-500
wound healing
The central technical issue is identity: FDA treated the seven-amino-acid TB-500 fragment as distinct from full-length thymosin beta-4 and found no direct human TB-500 evidence.
free base8–6–1Y · N · A · n=15
acetate8–6–1Y · N · A · n=15
04Day 1
PCAC favorable
MOTS-c
obesity · osteoporosis
The scientific premise is mitochondrial and metabolic, but FDA said it found no clinical study or human-administration evidence and no adequate nonclinical toxicity package.
free base7–5–2Y · N · A · n=14
acetate7–5–2Y · N · A · n=14
05Day 2
PCAC unfavorable
Emideltide (DSIP)
chronic insomnia · narcolepsy · opioid withdrawal
Emideltide had older human studies, but the record was small, methodologically uneven and largely intravenous rather than the nominated subcutaneous route.
free base6–7–1Y · N · A · n=14
acetate6–7–1Y · N · A · n=14
06Day 2
PCAC favorable
Epitalon
insomnia
The official record contained circadian and melatonin-related signals, but no direct insomnia trial using the nominated SC product and no clinical safety record.
free base7–4–1Y · N · A · n=12
acetate7–4–1Y · N · A · n=12
07Day 2
PCAC favorable
Semax
cerebral ischemia · migraine · trigeminal neuralgia
Semax had a wider pharmacology literature and limited clinical references, but FDA found the direct clinical record too small and methodologically weak for the nominated uses.
free base8–5–1Y · N · A · n=14
acetate8–5–1Y · N · A · n=14
Voices from the hearing
What was said—without blurring it into evidence.
These recording-checked moments illuminate the access, product-quality and online-market arguments. They are speaker statements, not FDA findings or proof of safety or effectiveness.
01Audio-checked paraphrase
Supports listingThe supply-chain distinction
Tatem challenged the use of research-use-only certificates as representative of material sourced for human-use compounding. His point was that an uncontrolled research market and a licensed pharmacy supply chain should not be treated as the same product-quality system.
Alex Tatem, MDbpc-157 session · attributed argument, not an established fact · 01:42:20–01:43:00
02Audio-checked paraphrase
Supports listingThe discovery-science case
Cohen identified himself as the dean of USC’s gerontology school and said MOTS-c was discovered in his laboratory. He described it as a mitochondria-encoded metabolic regulator and summarized preclinical work involving metabolism, muscle biology and age-related decline.
Pinchas “Hassy” Cohen, MDMOTS-c session · discovery and preclinical evidence · 10:08:27–10:09:39
03Audio-checked paraphrase
Supports listingThe access argument
Rosselló argued that removing supervised clinical access without a replacement can redirect patients toward an unregulated market.
Ricardo Rosselló, PhDSemax session · policy and access argument · 06:38:06–06:38:39
04Audio-checked paraphrase
Opposes listingThe hearing-wide case against all seven
Lurie said CSPI opposed adding all seven substances. He argued that the FDA criteria had not been met, that compounded products could create consumer risks, and that listing could weaken incentives for development through the standard drug-approval pathway.
Peter Lurie, MD, MPHOpening public hearing · explicitly applied to all seven substances · 00:57:09–00:57:55
Publication boundary
Choose a peptideUnverified transcript summaries stay unpublished.
Only named, source-reconciled speaker moments that were checked against the recording appear here. Statements remain attributed arguments unless the underlying evidence was independently established; no machine-caption wording is published as a quotation.
Source room
Go from the review to the original record.
The useful part of verification is the locator. Every vote, FDA finding and published hearing statement takes the reader back to the source.
Official event file
FDA meeting record
Agenda, roster, briefings, presentations and webcast links.
Open the official recordDay 1BPC-157 · KPV · TB-500 · MOTS-c
FDA presentation deck and linked webcast evidence.
Open Day 1 deckDay 2Emideltide · Epitalon · Semax
FDA presentation deck and linked webcast evidence.
Open Day 2 deckHow labels work
- Quotation · wording checked against audio
- Paraphrase · wording checked against the recording
- FDA finding · official briefing or presentation
Decision boundaryPCAC advice is not FDA approval, does not establish safety or effectiveness, and did not itself place either form on the 503A Bulks List.
Member-level ballots and industry-ties profiles are also published on the PCAC vote tracker. Both surfaces read the same data modules. FDA introduction