FDA OKs oral Wegovy
The FDA has approved the first oral form of Wegovy (semaglutide) for chronic weight management — a pill based on Phase III OASIS 4 data that Novo Nordisk plans to roll out in the US with manufacturing in North Carolina and a January 2026 full launch. Novo is marketing the pill as the most affordable self-pay GLP‑1 option to widen access beyond injections. FDA Approves Oral Wegovy Following Positive Phase III OASIS 4 Trial Results
OASIS [4 reported]nejm.org a mean weight reduction of 16.6% at 64 weeks with full adherence, and the trial’s treatment‑policy analysis still showed 13.6% weight loss versus roughly 2–3% for placebo. appliedclinicaltrialsonline.com Gastrointestinal side effects were the most common adverse events: nausea occurred in 46.6% of oral‑semaglutide recipients versus 18.6% with placebo, and vomiting in 30.9% versus 5.9%; serious adverse events were reported in 3.9% of the semaglutide group versus 8.8% of placebo in the trial data. biospace.com The randomized OASIS 4 cohort totaled 307 adults (205 assigned to oral semaglutide, 102 to placebo), the study excluded people with diabetes, and the enrolled population was about 79% women with a mean age near 48 years. clinicaltrials.gov Novo Nordisk has been scaling U.S. manufacturing ahead of rollout, investing roughly $4.1 billion in a second fill‑finish plant at its Clayton, North Carolina campus that will add about 1.4 million square feet of capacity. fiercepharma.com For initial U.S. self‑pay channels, Novo and partners rolled out introductory cash pricing in early January 2026 at roughly $149–$299 per month depending on dose, a $149 limited‑time offer also appeared through WeightWatchers Med+ promotions, and Novo signed distribution arrangements with telehealth platforms including Hims & Hers to broaden access. prismnews.com
