Oral Wegovy approved
The FDA approved oral semaglutide as the first GLP‑1 pill for weight loss, and AJMC reports the OASIS‑4 trial showed mean weight loss of 13.6% at 64 weeks — with Novo Nordisk planning a U.S. launch of once‑daily Wegovy 25 mg. ( | ).
Wegovy is now approved in the United States as a pill, giving obesity patients the first glucagon-like peptide-1 weight-loss drug that does not require an injection. (fda.gov) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel fuller and eat less. The new oral version is semaglutide 25 milligrams taken once a day, while the older Wegovy product is a once-weekly shot. (fda.gov | nejm.org) The Food and Drug Administration label says Wegovy tablets are approved with a reduced-calorie diet and increased physical activity for adults with obesity, or adults with overweight plus at least one weight-related condition. The same label also lists use to reduce major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. (fda.gov) The main evidence came from OASIS 4, a 71-week randomized trial at 22 sites in four countries. Researchers enrolled 307 adults without diabetes and found mean weight change at week 64 was minus 13.6 percent with oral semaglutide versus minus 2.2 percent with placebo. (nejm.org) In that trial, 205 participants received oral semaglutide and 102 received placebo, both alongside lifestyle counseling. Patients taking the pill were also more likely to lose at least 5 percent, 10 percent, 15 percent, and 20 percent of body weight. (nejm.org) The tradeoff was stomach-related side effects, which are common across this drug class. Gastrointestinal adverse events were reported in 74.0 percent of the oral semaglutide group and 42.2 percent of the placebo group in OASIS 4. (nejm.org) The Food and Drug Administration label carries the same boxed warning already used on semaglutide products about thyroid C-cell tumors seen in rodents. The drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) The approval also extends Novo Nordisk’s semaglutide franchise at a time when demand for obesity drugs has pushed manufacturers to add new doses, formats, and supply. In March 2026, the Food and Drug Administration also approved a higher-dose Wegovy injection, 7.2 milligrams, marketed as Wegovy HD. (fda.gov | fda.gov) Novo Nordisk told American Journal of Managed Care it planned a United States launch in early January 2026, and the company’s United States news archive later highlighted post-approval promotion for the Wegovy pill in April 2026. The practical change is simple: patients and prescribers now have a second semaglutide format to choose from, pill or shot. (ajmc.com | novonordisk-us.com)
