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Rats grow thyroid tumors on GLP-1 drugs. A new analysis says humans are built differently.

The boxed warning on every GLP-1 drug traces to thyroid C-cell tumors in rats and mice. A new weight-of-evidence analysis in Regulatory Toxicology and Pharmacology runs seven approved GLP-1 receptor agonists through the ICH S1B(R1) framework and concludes the rodent tumors arise through a mechanism largely absent in humans, where thyroid C-cells carry very few GLP-1 receptors, so further two-year rat bioassays add no value. It is an argument to test less, not new human data, authored by a consulting firm with a Novartis co-author, and the boxed warning plus the MTC and MEN2 contraindication still stand.

13d ago · Regulatory · @pavel GLP-1RGIPR 4 min read
Retatrutide stays in the blood for weeks and never reaches the urine

A Brazilian doping-control lab dosed four volunteers with the experimental triple-agonist and tracked it in both fluids. Plasma held a detectable signal for about 56 days. Urine, the workhorse of sports testing, came up empty every time, which closes off the cheap screen for a drug that has no regulatory approval anywhere.

24d ago · Regulatory · @pavel GLP-1RGIPRGCGR 4 min read
FDA approved rusfertide, the first hepcidin-mimicking peptide, for polycythemia vera

Rusfertide (MIMRYLO) imitates hepcidin, the body's iron-traffic hormone, starving overactive marrow of the iron it needs to build red cells. In the 293-patient VERIFY trial it cut the need for bloodletting and held hematocrit down. The endpoint is disease burden, not the clots and cancers that make the disease dangerous.

Sep 1, 2026 · Regulatory · @pavel 4 min read
The FDA Panel Cleared Six Peptides and Rejected the Seventh

The FDA's compounding advisory committee closed a two-day peptide session Friday by recommending Semax (8 to 5) and Epitalon (7 to 4), then rejecting Emideltide, or DSIP, 6 to 7. It was the only no vote across seven peptides. Six now head toward a rulemaking that could take up to 18 months, every one of them over the objection of the FDA's own scientists.

Jul 25, 2026 · Regulatory · @pavel NEUROPROTECTIVELONGEVITYANTI-AGING 3 min read
Off the shortage list, compounded GLP-1 knockoffs kept selling in two states

A JAMA Health Forum secret-shopper study found 75 clinics in West Virginia and Oklahoma still selling compounded copies of Ozempic and Mounjaro after the shortages ended, more than half mixed with B vitamins and nearly one in five suppliers unlicensed to compound sterile injectables.

Jul 18, 2026 · Regulatory · @pavel GLP-1RGIPR 3 min read
The first oral PCSK9 pill is approved, matching the shots at a third the price

The FDA approved Merck's LIPFENDRA (enlicitide) on July 16 as the first oral PCSK9 inhibitor, a once-daily macrocyclic peptide tablet that cut LDL cholesterol 56 and 59 percent against placebo in two Phase 3 trials, matching injectable antibodies at a $315-a-month list price, roughly a third of the injections. The approval rests on LDL, not heart-attack prevention; the cardiovascular outcomes trial does not report until 2029. An approved, priced, once-daily macrocyclic peptide is the clearest sign yet the oral-peptide class has cleared its chemistry problem.

Jul 17, 2026 · Regulatory · @pavel 4 min read
China approved the first cAMP-biased GLP-1. Its weight-loss edge is unproven.

Ecnoglutide, from Sciwind Biosciences, is the first GLP-1 drug built to drive one signaling arm and ease off another. China cleared it for diabetes and obesity six weeks apart, and Pfizer paid up to $495 million for the China rights. Its roughly 15 percent weight loss has not yet beaten the incumbents.

Jul 8, 2026 · Regulatory · @pavel GLP-1R 3 min read
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