Peptide News Digest

#Dihexa

2 stories

Regulatory · View digest

FDA Confirms Second PCAC Meeting Before End of February 2027 — GHK-Cu (Injectable), Melanotan II, Cathelicidin LL-37, Dihexa Acetate, PEG-MGF for 503A Bulks-List Review

The FDA confirmed the Pharmacy Compounding Advisory Committee will convene a second meeting before the end of February 2027 to review five additional peptides for potential 503A Bulk Drug Substances List inclusion: GHK-Cu (injectable formulation specifically — topical/cosmetic remains separate), Melanotan II, Cathelicidin (LL-37), Dihexa acetate, and Mechano Growth Factor Pegylated (PEG-MGF). The February 2027 meeting follows the July 23-24, 2026 PCAC that will review seven peptides (BPC-157, KPV, TB-500, MOTs-C on Day 1; Emideltide/DSIP, Semax, Epitalon on Day 2). Compounding pharmacies cannot legally compound these five peptides until the PCAC review concludes and the FDA issues a final determination — a 6-12 month timeline post-meeting. The peptide-specific indications under review span aesthetic dermatology (GHK-Cu, Melanotan II), antimicrobial activity (LL-37), neuroprotection (Dihexa), and growth-factor-mediated tissue regeneration (PEG-MGF).

Industry · View digest

Umbrella Labs Dihexa Peptide Documentation and Traceability Update (May 19) — Reference-Material Standardization Ahead of February 2027 PCAC Review

Umbrella Labs announced Tuesday May 19 a documentation and traceability update for its dihexa peptide reference material, provided strictly for laboratory developmental research use. The update is part of the company's ongoing standardization initiative focused on identity-field consistency, record continuity, and reproducibility support for research laboratories. The timing aligns with the FDA-confirmed February 2027 PCAC meeting that will review dihexa acetate for potential 503A bulks-list inclusion alongside GHK-Cu, Melanotan II, LL-37, and PEG-MGF. Dihexa is a small angiotensin IV-derived peptide originally studied at Washington State University for hepatocyte growth factor activation and neuroprotection. Reference-material traceability standards are a soft signal of the regulatory cycle compounding pharmacies and supply chains are preparing for ahead of the PCAC review.