Regulatory updates & industry news
Tracking enforcement actions, reclassification developments, and market shifts in the peptide space.
FDA Proposes to Permanently Exclude Compounded Semaglutide, Tirzepatide, and Liraglutide
FDA's May 1, 2026 proposal would strike the three leading GLP-1s from the 503B outsourcing-facility bulks list on a 'no clinical need' finding — a permanent step beyond the shortage-list dynamics. The public comment period was extended to July 30, 2026.
8 min readResearch Peptides Are Entering Registered Trials — by One Sponsor, at One Site
BPC-157, TB-500, GHK-Cu, and MOTS-c now have registered human trials. But they trace to a single sponsor at a single hospital, and a registration is not evidence. A skeptical look at what these filings do and don't mean.
7 min readNew Study Finds No Definitive Signal of Harm From First-Trimester GLP-1 Exposure
A June 2026 Annals of Internal Medicine study of 3,572 pregnancies found similar outcomes whether women continued or stopped a GLP-1 at conception — measured reassurance for accidental exposure, though label guidance to discontinue in pregnancy still stands.
7 min readRetatrutide's Pivotal Obesity Trial Reports at ADA 2026 — and a New Safety Signal
TRIUMPH-1, retatrutide's largest trial, showed 28.3% average weight loss at 80 weeks and improved sleep apnea and knee pain — but also surfaced a urinary tract infection signal, mostly in women, that had not appeared in earlier trials.
7 min readDoes This Mean BPC-157 Is Legal Now?
FDA review does not mean approval, 503A is not over-the-counter access, and compounding is not FDA approval. A precise answer to the BPC-157 legal-status confusion.
6 min readJuly 2026 PCAC Peptide Hub: BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon
The FDA's Pharmacy Compounding Advisory Committee will review seven peptide bulk drug substances in July 2026. Track the status, evaluated uses, evidence grades, and what yes or no votes would mean.
5 min readFDA Calls July PCAC Meeting on Seven Category 2 Peptides
On April 15, 2026, the FDA issued a Federal Register notice convening the Pharmacy Compounding Advisory Committee in July to review seven Category 2 peptides — including BPC-157 — for possible return to Category 1.
6 min readRetatrutide Clears First Late-Stage Diabetes Trial: TRANSCEND-T2D-1 Results
Eli Lilly's triple agonist retatrutide showed A1C reductions of up to 2.0% and weight loss of up to 16.8% in the TRANSCEND-T2D-1 Phase 3 trial — with dysesthesia rates dramatically lower than TRIUMPH-4.
7 min readFirst Randomized Controlled Trial for BPC-157: What to Expect
A landmark RCT for BPC-157 began recruiting in February 2026 — the first rigorous human trial for one of the most popular peptides. Here's what it will and won't tell us.
6 min readSemaglutide Compounding Under Scrutiny: The Novo Nordisk Supply Update
As GLP-1 supply normalizes and lawsuits mount, compounded semaglutide faces an uncertain future. What consumers need to know.
7 min readFDA Enforcement and the Gray Market: What's Happening in 2026
From criminal prosecutions to warehouse raids, the FDA is cracking down on unregistered peptide sellers. A timeline of enforcement actions and what they signal.
8 min readWhat Happened to Peptide Sciences
The largest gray-market peptide vendor shut down on March 6, 2026. Here's what happened, why it matters, and what comes next.
6 min readWhat Are Compounding Pharmacies and Why Do They Matter for Peptides?
Compounding pharmacies are central to legal peptide access. Here's how they work, the 503A vs 503B distinction, and what reclassification means for the industry.
8 min readKennedy Peptide Reclassification: What Changed and What It Means
On February 27, 2026, HHS Secretary Kennedy signaled that ~14 peptides could move from Category 2 to Category 1. Here's what that means for access, clinics, and consumers.
7 min readUnderstanding Peptide Categories: FDA's Classification System Explained
The FDA's Category 1, 2, and 3 system determines which peptides can be compounded. Here's how it works, what's in each category, and why reclassification matters.
7 min read