Status
Scheduled for PCAC review
FDA-evaluated use
Ulcerative colitis
Evidence grade
Very low human evidence
Strong animal literature and only a few small human reports; no completed modern randomized trial yet.
Regulatory hub
July 2026 PCAC peptide agenda
One place to track the FDA advisory committee review for BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon: status, evaluated use, evidence grade, and what a yes or no vote would actually mean.
Source checked May 16, 2026 against the FDA meeting notice. The meeting is scheduled for July 23-24, 2026, so agenda materials and docket details may change before the vote.
Meeting dates
July 23-24, 2026
Pharmacy Compounding Advisory Committee, open public session.
Comment timing
July 9 / July 22
Comments by July 9 are supplied to the committee; the public docket closes July 22.
Decision scope
503A bulks list
The agenda is about compounding eligibility from bulk substances, not drug approval.
Agenda table
Seven peptides, seven narrow FDA-reviewed uses
The evaluated use is the use listed on the FDA agenda. It is not a clinical recommendation, and it does not mean the FDA has found the peptide effective for that condition.
Status
Scheduled for PCAC review
FDA-evaluated use
Wound healing and inflammatory conditions
Evidence grade
Preclinical only
Anti-inflammatory mechanism and animal colitis work are plausible; Peptide Garden has found no human clinical trials.
Status
Scheduled for PCAC review
FDA-evaluated use
Wound healing
Evidence grade
Very low direct evidence
Human studies exist for full-length thymosin beta-4, but not for the short TB-500 fragment sold online.
Status
Scheduled for PCAC review
FDA-evaluated use
Obesity and osteoporosis
Evidence grade
Minimal human evidence
The mouse and mechanism story is strong; controlled human evidence for native MOTS-c remains essentially absent.
July 24Profile planned
Emideltide / DSIP
Emideltide / Delta Sleep-Inducing Peptide
Full profile not live yet
Status
Scheduled for PCAC review
FDA-evaluated use
Opioid withdrawal, chronic insomnia, and narcolepsy
Evidence grade
Very low, dated evidence
Small older sleep studies exist, but no modern clinical development program or robust contemporary safety package.
Status
Scheduled for PCAC review
FDA-evaluated use
Cerebral ischemia, migraine, and trigeminal neuralgia
Evidence grade
Low to limited
Clinical use exists in Russia and Ukraine, but there are no FDA-approved indications or Western registration trials.
July 24Profile planned
Epitalon
Epitalon, free base and acetate salt
Full profile not live yet
Status
Scheduled for PCAC review
FDA-evaluated use
Insomnia
Evidence grade
Very low, limited replication
Older Russian human reports and in-vitro telomere work do not add up to a modern safety or efficacy package.
Vote translator
What a yes or no PCAC vote means
PCAC recommendations matter, but they are advisory. FDA still decides what happens to the 503A bulks list after the meeting.
If PCAC votes yes
A possible path to legal 503A compounding
A yes vote would recommend that FDA allow the substance on the 503A bulk drug substances list for the reviewed scope. If FDA later follows that recommendation, a state-licensed compounding pharmacy could potentially compound it with a patient-specific prescription.
It would not make the peptide FDA-approved, prove efficacy, validate online research-chemical sellers, or settle dosing.
If PCAC votes no
Continued uncertainty or restriction
A no vote would recommend against adding the substance to the 503A bulks list. If FDA follows that recommendation, compounding from bulk drug substance would likely remain unavailable through ordinary 503A pharmacy pathways.
It would not prove the peptide never works. It would mean the committee did not find the current package adequate for this compounding pathway.
How to read this hub
Evidence methodologyEvidence grade and regulatory status answer different questions.
Evidence grade reflects Peptide Garden's read of human clinical evidence and safety data. PCAC status reflects where a substance sits in the FDA's compounding review workflow. A weak evidence grade can still appear on a PCAC agenda, and a PCAC vote can still leave major clinical questions unanswered.