First oral GLP‑1 pill cleared

The FDA issued its approval for oral Wegovy (semaglutide) on December 22, 2025, and Novo Nordisk planned a full U.S. launch of the once‑daily 25 mg tablet in early January 2026. (ajmc.com ) The phase 3 OASIS‑4 program randomized 307 adults in a 64‑week trial and reported a primary‑estimand mean weight change of −13.6% for oral semaglutide versus −2.2% for placebo at week 64. (ajmc.com ) Under a trial‑product (hypothetical) estimand in OASIS‑4 the mean treatment effect was −16.6% weight change, and trial publications reported that roughly 34.4% of treated participants achieved ≥20% weight loss. (biospace.com ) The updated U.S. prescribing information lists tablet indications to reduce major adverse cardiovascular events (MACE) in adults with established cardiovascular disease and to reduce and maintain body weight in adults with obesity or overweight, and it retains a boxed warning about risk of thyroid C‑cell tumors with contraindication in patients with personal or family history of medullary thyroid carcinoma or MEN2. (accessdata.fda.gov ) Novo Nordisk said the initial starter dose (1.5 mg) would be available through pharmacies and select telehealth providers, and the company promoted a self‑pay savings offer at $149 per month for the introductory dose. (cnbc.com ) Manufacturing for the Wegovy pill was reported to be underway at Novo Nordisk’s North Carolina facilities and the company announced the product became broadly available across the United States in early January 2026. (prnewswire.com ) Novo’s injectable Wegovy generated about $7.1 billion in global sales in 2025, giving the company a sizeable existing obesity franchise as it brings the oral format to market. (beckershospitalreview.com ) Eli Lilly’s oral GLP‑1 candidate orforglipron remains in regulatory review with the FDA’s target action date pushed to April 10, 2026, a timing that gives Novo an early commercial window in the oral obesity category. (biospace.com )