Peptide News Digest

PCAC Day 2: Semax and Epitalon Recommended, DSIP Rejected, Merck-Aspen HIV Prevention Licensing

PCAC Day 2: Semax and Epitalon recommended, DSIP rejected. 6 of 7 peptides cleared across two days. Merck licenses monthly HIV pill to Aspen + 6 others.

5 stories · Covering regulatory, industry, clinical-trials

Editor's Note

The FDA Pharmacy Compounding Advisory Committee (PCAC) closed its two-day peptide session at White Oak Friday with Semax recommended 8-5 for cerebral ischemia, migraine, and trigeminal neuralgia, Epitalon recommended 7-4 for insomnia, and Emideltide (DSIP) narrowly rejected in the sole no vote of the two days. Combined with Thursday's four Day 1 wins (BPC-157 8-6-1, KPV 8-6-1, TB-500 8-6, MOTS-c 7-5-2), the total tally comes to 6 of 7 peptides recommended for the Section 503A Bulks List, all against the explicit FDA career-staff position. Coverage across STAT News, Time Magazine, NPR, ABC News, Bloomberg, US News, and The Hill converged on the framing that HHS Secretary Robert F. Kennedy Jr.'s peptide push crossed a substantive advisory threshold. What has not changed: the 6 recommended peptides still need FDA leadership review, a proposed rule, a public comment period, and a final rule before compounding pharmacies can legally prepare them under 503A. Rulemaking typically takes 6-18 months. Away from PCAC, Merck (MSD) announced voluntary licensing agreements with Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), UCL Kenya, Aurobindo, Cipla, Emcure, and Viatris (India) for MK-8527 (alimatravir), an investigational once-monthly oral HIV prevention pill covering 129 low- and middle-income countries. AIDS 2026 opens Sunday July 26 in Rio de Janeiro with the Gilead-Merck ISLEND-1 and ISLEND-2 Phase 3 late-breaker on Wednesday July 29.

Regulatory

PCAC Day 2 on Friday July 24, 2026 Votes to Recommend Semax 8-5 for Adult Cerebral Ischemia, Migraine, and Trigeminal Neuralgia and to Recommend Epitalon 7-4 for Adult Insomnia While Narrowly Voting to Recommend Against Adding Emideltide (Delta Sleep-Inducing Peptide, DSIP) to the Section 503A Bulks List; Two of Three Day-2 Peptides Clear the Panel Against FDA Career-Staff Recommendation While Emideltide Becomes the Only Peptide of the Seven Under Two-Day Review That Failed to Secure a Majority

The FDA Pharmacy Compounding Advisory Committee (PCAC) closed the two-day peptide session Friday July 24, 2026 with two more advisory wins and one narrow rejection. Semax, a synthetic heptapeptide derived from the ACTH(4-10) sequence developed in Russia as a nootropic, was recommended 8-5 for the Section 503A Bulks List for adult cerebral ischemia, migraine, and trigeminal neuralgia. Epitalon, a synthetic tetrapeptide nominated for insomnia and anti-aging, was recommended 7-4 for adult insomnia. Emideltide (delta sleep-inducing peptide, DSIP), a nonapeptide first isolated from rabbit brain in 1974 and nominated for insomnia and opioid withdrawal, was narrowly voted against, the sole rejection of the two-day session. STAT News framed the Day 2 outcome as 'FDA advisory panel narrowly rejects compounding of one peptide, backs two others.' FDA career-staff briefing documents released June 29-30 recommended against all three Day-2 peptides, citing insufficient evidence of effectiveness for Epitalon in insomnia and 'balancing of the criteria weighs against' Semax. The recommendations are advisory only.

#pcac #fda #semax #epitalon #emideltide #dsip #peptide-compounding #503a-bulks-list #day-2 #cerebral-ischemia #insomnia #career-staff
Regulatory

Day 1 Afternoon Session Vote Tallies Clarified for Thursday July 23: PCAC Voted 8-6 to Recommend Adding TB-500 (Thymosin Beta-4 Fragment for Tissue Repair) to the Section 503A Bulks List and Voted 7-5 With 2 Abstentions to Recommend Adding MOTS-c (Mitochondrial-Derived Peptide for Obesity and Metabolic Disease) Alongside the Morning Session Votes for BPC-157 (8-6-1) and KPV (8-6-1); All Four Day-1 Peptides Cleared the Panel and All Four Wins Override FDA Career-Staff Recommendations

Day 1 afternoon session vote tallies clarified Friday for Thursday July 23, 2026: the FDA Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 to recommend adding TB-500 (thymosin beta-4 fragment, marketed for wound healing and tissue repair) to the Section 503A Bulks List, and voted 7-5 with 2 abstentions to recommend adding MOTS-c (mitochondrial-derived peptide, nominated for obesity and metabolic disease). Both afternoon votes followed the morning session votes on BPC-157 (8-6, 1 abstention) and KPV (8-6, 1 abstention), making Thursday a clean sweep of all four Day-1 peptides. Every Day-1 win overrode the FDA career-staff briefing documents released June 29-30, which recommended against adding any of the seven peptides under review. Coverage across US News, ABC News, Bloomberg, The Hill, and Medical Daily converged on the framing that FDA career scientists were rebuked by the advisory panel on Day 1. TB-500 has been actively marketed alongside BPC-157 in 'tissue repair' and 'recovery' peptide-clinic protocols; MOTS-c has been marketed for metabolic health and mitochondrial function despite thin human clinical evidence.

#pcac #fda #tb-500 #mots-c #bpc-157 #kpv #peptide-compounding #503a-bulks-list #day-1 #thymosin-beta-4 #mitochondrial-peptide
Regulatory

Two-Day Session Synthesis: 6 of 7 Research Peptides Recommended by the FDA Pharmacy Compounding Advisory Committee for the Section 503A Bulks List Across Thursday July 23 and Friday July 24, 2026, With Only Emideltide (DSIP) Failing to Secure a Majority; All Six Wins Override the FDA Career-Staff Position and Represent the Broadest Advisory Endorsement of Compounding-Channel Peptides in the Committee's History; STAT News and Time Magazine Frame the Outcome as a Win for HHS Secretary Robert F. Kennedy Jr. and Continued Rulemaking Timeline of 6-18 Months Still Applies Before Actual Compounding-Pharmacy Access Changes

The two-day FDA Pharmacy Compounding Advisory Committee (PCAC) session closed Friday July 24, 2026 with 6 of 7 research peptides recommended for the Section 503A Bulks List. Day 1 wins: BPC-157 (8-6-1), KPV (8-6-1), TB-500 (8-6), MOTS-c (7-5-2). Day 2 wins: Semax (8-5), Epitalon (7-4). Day 2 rejection: Emideltide/DSIP. Every one of the 6 wins overrode the FDA career-staff briefing documents that recommended against adding any of the seven peptides. STAT News, Time Magazine, NPR, ABC News, Bloomberg, US News, The Hill, and Washington Times converged on the framing that HHS Secretary Robert F. Kennedy Jr.'s peptide-access push cleared a substantive advisory threshold. Panel composition itself was a substantive factor: eight new PCAC members were named June 29, with at least seven documented to have peptide-industry ties per STAT News. What still has to happen before actual compounding-pharmacy access changes: FDA leadership must review each vote, decide whether to accept it, publish a proposed rule in the Federal Register, run a 60-90 day public comment period, respond to comments, and publish a final rule with an effective date. Rulemaking typically takes 6-18 months per substance from the date the FDA decides to act.

#pcac #fda #peptide-compounding #503a-bulks-list #rfk-jr #career-staff #two-day-synthesis #rulemaking-timeline #advisory-vote #white-oak
Industry

Merck (MSD) Announces Friday July 24 Voluntary Licensing Agreements With Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in Sub-Saharan Africa Plus Aurobindo, Cipla, Emcure, and Viatris in India for Investigational Once-Monthly Oral HIV Prevention Pill MK-8527 (Alimatravir) Covering 129 Low- and Middle-Income Countries Including Every African Nation; Late-Stage Phase 3 Clinical Trial Results for Alimatravir Are Not Expected Until Late 2027

Merck (MSD) announced Friday July 24, 2026 seven voluntary, royalty-free, non-exclusive licensing agreements with generic drug manufacturers covering the investigational once-monthly oral HIV prevention pill MK-8527 (alimatravir). The licensees are Aspen Pharmacare (South Africa), Quality Chemical Industries (Uganda), and UCL Kenya in sub-Saharan Africa, plus Aurobindo, Cipla, Emcure, and Viatris in India. The territorial scope covers 129 low- and middle-income countries including every African nation. Alimatravir is an investigational late-stage once-monthly long-acting oral medicine for HIV-1 prevention, currently in Phase 3 development. Phase 3 topline results are not expected until late 2027. Alimatravir is designed to provide one month of protection from HIV-1 starting within one hour after dosing. Coverage frames the licensing structure as one of the broadest generic-access pre-approval commitments Merck has undertaken for an HIV asset. The announcement follows the April 7 STAT reporting that Merck's experimental HIV prevention pill could be made for less than $5 a year at manufacturing cost. Merck plans to file for regulatory approval in 2027-2028 with market launch dependent on Phase 3 outcome.

#merck #msd #aspen-pharmacare #alimatravir #mk-8527 #hiv-prevention #voluntary-licensing #generic-access #africa #india #low-middle-income-countries
Clinical Trials

AIDS 2026 Conference (26th International AIDS Conference) Opens Sunday July 26, 2026 in Rio de Janeiro, Brazil With Gilead Sciences and Merck's Investigational Once-Weekly Oral HIV Treatment Regimen Islatravir 2 mg / Lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 Detailed Data Scheduled for the Late-Breaking Session Wednesday July 29; Topline Numbers Released July 21 Showed 0% of Once-Weekly ISL/LEN Participants Had HIV-1 RNA at 50 Copies/mL or Higher at Week 48 in ISLEND-1 Versus 0.3% Remaining on Daily Biktarvy

The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through July 31. Gilead Sciences and Merck's Phase 3 ISLEND-1 and ISLEND-2 detailed data on the investigational once-weekly oral HIV treatment regimen islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) is scheduled for the late-breaking session on Wednesday July 29. Topline numbers released July 21 showed 0% of once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 in ISLEND-1 (versus 0.3% of participants who remained on daily Biktarvy). In ISLEND-2, 0.3% of participants receiving weekly ISL/LEN had HIV-1 RNA at 50 copies/mL or higher versus 1.3% on daily standard of care regimens. Safety profile was generally similar to comparator regimens with no new signals identified. Lenacapavir is a first-in-class HIV capsid inhibitor (peptide-adjacent modality); islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI). The data will support planned regulatory submissions and represents the first once-weekly oral HIV treatment regimen to clear Phase 3 endpoints. Merck also plans to present daily, weekly, and monthly HIV treatment and prevention pipeline updates at AIDS 2026.

#aids-2026 #gilead #merck #islend-1 #islend-2 #islatravir #lenacapavir #hiv #once-weekly #phase-3 #biktarvy #rio-de-janeiro