Lilly launches Foundayo with $1.5B pre-stocked; FDA escalates compounding crackdown; Merck oral peptide PCSK9 inhibitor impresses; Reddit study reveals GLP-1 side effects.
10 stories · Covering industry, regulatory, clinical-trials, research
The oral GLP-1 race officially heats up as Eli Lilly launches Foundayo (orforglipron) just eight days after FDA approval with $1.5B pre-stocked, competing directly with Novo Nordisk's oral Wegovy. Regulatory pressure intensifies—the FDA escalates its crackdown on compounded GLP-1 telehealth operations while Health Canada issues a stark warning against unauthorized injectable peptides. On the research front, Merck's oral peptide PCSK9 inhibitor delivers injectable-level cholesterol lowering in pill form, and a 410K-post Reddit analysis reveals real-world GLP-1 side effect patterns far beyond clinical trial data.
Eli Lilly formally launched Foundayo (orforglipron) eight days after FDA approval, having pre-stocked $1.5 billion worth of the drug. The oral obesity market now features a direct Lilly vs Novo Nordisk competition.
The FDA is intensifying enforcement against compounding pharmacies selling unapproved GLP-1 products, threatening seizure and injunction. Hims & Hers was specifically named following the February 2026 TrumpRx launch.
Merck's investigational oral macrocyclic peptide PCSK9 inhibitor demonstrated significantly greater LDL-C reductions at 8 weeks vs guideline-recommended oral non-statin therapies, delivering injectable-level cholesterol lowering in pill form.
Researchers analyzed 410,198 Reddit posts mentioning semaglutide or tirzepatide, finding 43.5% of 67,008 self-reported users described at least one side effect extending beyond clinical trial data.
Health Canada warned Canadians against injecting unauthorized peptides purchased online, citing risks of organ damage and infection from products misleadingly labeled 'For Research Use Only.'
Semaglutide injections officially removed from the FDA drug shortage list, though localized availability issues persist. Tirzepatide shortage status remains contested by the Outsourcing Facilities Association.
Clarivate projects orforglipron and retatrutide as the defining GLP-1 drugs of the next decade. Retatrutide is projected for 2028 launch after seven additional Phase III readouts expected this year.
MetaVia dosed the first patient in a higher-dose Phase 1 study of DA-1726, its GLP-1 and glucagon dual agonist for obesity treatment, marking continued advancement in next-gen weight loss drugs.
UC launched a clinical trial using Peptilogics' peptide-based antimicrobial agent to treat prosthetic joint infections by targeting bacterial biofilms that have resisted traditional therapies.
A new review highlights GLP-1 RAs achieving a 55% reduction in apnea-hypopnea index and 14.9% mean weight loss in non-diabetic populations, with pleiotropic effects across cardiovascular, renal, and skeletal systems.