Regulatory and Evidence updates for Peptides & more

An FDA panel backed six peptides for compounding — against the FDA's own reviewers. On July 23 the Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157, KPV and TB-500 (8–6, one abstention each) and MOTS-c (7–5, two abstentions) to the 503A compounding list. On July 24 it added semax (8–5) and epitalon (7–4), and rejected emideltide — better known as DSIP. FDA's own reviewers had recommended against every one. In June the agency seated eight temporary voting members nominated by the HHS Secretary's office; six had sold peptide products themselves, per STAT.

Centanafadine is approved. The FDA cleared centanafadine on July 24 as SIMTRIYO, for ADHD in adults and children 6+ weighing at least 20 kg. It's the first approved ADHD drug to block norepinephrine, dopamine and serotonin reuptake at once, and it isn't a scheduled drug. Most common side effects: decreased appetite, rash, vomiting.

Semaglutide showed a mortality benefit; tirzepatide cost the most lean mass. An independent 262-trial network meta-analysis in The BMJ found tirzepatide produced the largest fat loss and the largest lean-mass loss (−8.3%), while semaglutide was the only agent showing a standalone all-cause mortality benefit (RR 0.81) outside its own SELECT trial.

Retatrutide finally has a peer-reviewed Phase 3. TRANSCEND-T2D-1 in The Lancet (537 people with type 2 diabetes): HbA1c down 1.94% and 15.3% body weight lost at 40 weeks on the top dose — ending a year of press-release-only claims. → retatrutide

Survodutide normalized liver fat in 6 of 10 patients. SYNCHRONIZE-MASLD in Nature Medicine was built specifically to test whether the drug's glucagon arm burns liver fat directly: 60% of participants with obesity and fatty liver disease reached liver-fat normalization at 48 weeks. → survodutide

Oveporexton (TAK-861). The first drug of its kind for wakefulness; FDA decision due this quarter.

GHK-Cu is next. A second compounding-committee meeting covering GHK-Cu and five more peptides is expected by February 2027.Watchlist