RFK Jr. signals FDA will lift restrictions on ~14 peptides, Lilly and Novo strike MFN pricing deals, and orforglipron outperforms oral semaglutide.
10 stories · Covering regulatory, industry, clinical-trials, research
Today's peptide news is dominated by a seismic regulatory shift: Health Secretary RFK Jr. has signaled that the FDA will soon lift restrictions on roughly 14 popular peptides — including BPC-157, ipamorelin, and MOTS-c — allowing compounding pharmacies to produce them again. This announcement, made on the Joe Rogan podcast, set off a firestorm of coverage across NPR, CBS, and financial media. Meanwhile, Eli Lilly and Novo Nordisk struck MFN pricing deals with the Trump Administration to lower GLP-1 drug costs, orforglipron showed superiority over oral semaglutide in ACHIEVE-3, and the EMA approved semaglutide as the first GLP-1 with formal cardiovascular and stroke benefits in Europe.
Health Secretary Kennedy announced on Joe Rogan's podcast that the FDA will soon reclassify about 14 peptides currently restricted from compounding pharmacies, aiming to curb gray-market sourcing.
Both pharma giants reached most-favored-nation pricing agreements with the Trump Administration to reduce costs of tirzepatide and semaglutide for American consumers.
Eli Lilly's oral orforglipron demonstrated superior HbA1c reduction and weight loss vs oral semaglutide in Phase 3, strengthening the case ahead of an April FDA decision.
Viking enrolled ~1,000 adults in the 78-week trial of VK2735, a GLP-1/GIP dual agonist. Phase 2 showed up to 14.7% body weight reduction in just 13 weeks.
The European Medicines Agency formally approved semaglutide with cardiovascular and stroke-related benefits — a first for any GLP-1 receptor agonist in Europe.
Companies are rushing to upgrade from gray-market research-grade to medical-grade peptide standards to supply doctors' offices as deregulation approaches.
Pinnacle closed an oversubscribed $89M Series B (total $134M) to advance AI-driven oral peptide therapeutics into clinical trials, focusing on immunology and cardiometabolic diseases.
New research finds approximately 25% of weight lost persists after GLP-1 discontinuation. Trajectories were similar across semaglutide, liraglutide, and tirzepatide.
Hims & Hers announced Novo Nordisk's approved GLP-1 medications including Wegovy injections/pills and Ozempic are now available through its platform at lower-than-retail rates.
CBS warns that viral peptide claims on social media far outpace clinical evidence, with 60% of 10.1M monthly searches related to GLP-1 drugs and many trending peptides lacking FDA approval.