OASIS‑4 backed approval

The Food and Drug Administration cleared Novo Nordisk’s Wegovy pill in December 2025 after Phase 3 OASIS 4 data showed strong weight loss and a safety profile regulators said matched earlier semaglutide studies. (fda.gov) (appliedclinicaltrialsonline.com) Wegovy tablets are once-daily oral semaglutide 25 milligrams, approved to reduce excess body weight and maintain weight loss long term in adults with obesity or overweight, and to reduce major cardiovascular events in certain adults with established cardiovascular disease. (fda.gov) (biospace.com) OASIS 4 enrolled 307 adults without diabetes and compared oral semaglutide 25 milligrams with placebo over 64 weeks, after a 12-week dose-escalation period and alongside lifestyle changes. (acc.org) In the trial’s primary analysis, body weight fell 14.0% with oral semaglutide versus 2.0% with placebo at week 64; 30% of treated participants lost at least 20% of body weight, compared with 3% on placebo. (acc.org) Novo Nordisk said the adherence-based analysis showed 16.6% mean weight loss, the figure it highlighted in its approval announcement and that trade publications cited in coverage of the decision. (biospace.com) (appliedclinicaltrialsonline.com) The safety picture in OASIS 4 looked like other glucagon-like peptide-1 drugs: stomach-related side effects were most common, affecting 74% of the semaglutide group versus 42% of placebo, and discontinuations were 7% versus 6%. (acc.org) The label carries the same boxed warning already used for semaglutide products, cautioning about thyroid C-cell tumors seen in rodents and barring use in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) Regulators also had data beyond the scale. Post hoc OASIS 4 analyses found bigger improvements than placebo in blood sugar measures, triglycerides, C-reactive protein, and other cardiovascular risk markers. (novonordisk.mediaroom.com) (appliedclinicaltrialsonline.com) Among participants who started with prediabetes, 71.1% on oral semaglutide had normal blood glucose at week 64, versus 33.3% on placebo in the company’s ObesityWeek 2025 analysis. (novonordisk.mediaroom.com) The approval gave Novo Nordisk a pill option for patients who do not want weekly injections, while keeping the same semaglutide franchise that already underpins injectable Wegovy and Ozempic. Novo Nordisk said it expected a full United States launch in early January 2026. (biospace.com) OASIS 4 did not settle every question about oral obesity drugs, but it gave the Food and Drug Administration a 64-week Phase 3 record showing that a daily pill could deliver double-digit weight loss with familiar semaglutide risks. (acc.org) (appliedclinicaltrialsonline.com)