The WHO's first global guidance on childhood obesity draws a hard line at age 10 for GLP-1 drugs, and allows them in teens only after a six-month lifestyle program fails.
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RSSThe WHO's first global guidance on childhood obesity draws a hard line at age 10 for GLP-1 drugs, and allows them in teens only after a six-month lifestyle program fails.
A European committee wants to give the peptide-drug conjugate Pepaxti to myeloma patients earlier in their care, based on the same Phase 3 trial that led the FDA to pull the drug from the US market in 2024.
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.
Lilly's Onswik cuts basal insulin from a daily shot to a weekly one. The QWINT trials show it matches daily insulin on blood sugar and lowers dangerous lows, but only in type 2 diabetes and only as a non-inferior result.
Among 92 million US adults with no FDA-approved reason to be on a GLP-1 drug, prescribing climbed from 0.1 to 1.5 percent in four years. Recipients skewed female, White, privately insured, and often not overweight at all.
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.
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.
The FDA's compounding advisers scheduled a second peptide meeting for before the end of February 2027, covering melanotan II, GHK-Cu, LL-37, dihexa, and PEG-MGF. There is no date and no docket yet, and the panel's last round cleared peptides with zero human trials.
Novo Nordisk ran compounded and follow-on copies of semaglutide and liraglutide through immune-response assays and reported they carry different impurities. The chemistry is real. So is the conflict of interest.
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.
After BPC-157 and KPV, the compounding committee voted 8-6 for TB-500 and 7-5 for MOTS-c. Both are banned in sport. Neither has ever been tested in a person.
The Pharmacy Compounding Advisory Committee recommended adding BPC-157 and KPV to the 503A bulks list, overruling FDA career scientists who said neither peptide had human safety or efficacy data. The vote is a recommendation, not a final rule.
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.
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.
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.