Oral semaglutide cleared
The FDA approved oral semaglutide as the first GLP‑1 pill for weight loss, creating a non‑injectable pathway for patients who need incretin‑based therapy for obesity. This approval could reshape access and prescribing patterns for weight management. (ajmc.com)
The phase 3 OASIS 4 trial enrolled 307 adults and reported a 16.6% mean weight loss with on‑treatment analysis and a 13.6% treatment‑policy mean weight loss at 64 weeks for oral semaglutide 25 mg versus ~2–3% with placebo. (nejm.org ) One in three participants on the 25 mg regimen lost ≥20% of body weight in OASIS 4, and the trial also showed improvements in physical function and cardiometabolic risk factors. (prnewswire.com ) The cardiovascular risk‑reduction indication in the label traces to the SELECT cardiovascular outcomes program, which enrolled about 17,604 adults with established CVD and found a roughly 20% relative reduction in major adverse cardiovascular events with semaglutide 2.4 mg. (nejm.org ) OASIS 4 reported mostly gastrointestinal adverse events as the most common side effects, with trial publications noting that adverse events occurred in >90% of participants on oral semaglutide and serious adverse events were reported less frequently with the drug (e.g., 3.9% vs 8.8% in one analysis). (ajmc.com ) (appliedclinicaltrialsonline.com ) Novo Nordisk announced a planned full U.S. launch in early January 2026, with manufacturing underway at North Carolina sites and an initial self‑pay starter price of $149 per month for the 1.5 mg starter dose cited in the company release. (prnewswire.com ) The product label lists contraindications including a personal or family history of medullary thyroid carcinoma or MEN 2, details dosing and administration guidance for the tablet formulation, and includes an accelerated‑approval pathway for a MASH (NASH) indication pending confirmatory data. (accessdata.fda.gov )
