FDA approves oral semaglutide for weight loss

The U.S. Food and Drug Administration approved Wegovy tablets for chronic weight management in adults on January 5, 2026, according to the agency’s approval letter. The decision added an oral version of semaglutide to a market that had been led by weekly injections for obesity treatment. Novo Nordisk markets injectable Wegovy and diabetes pill and injection versions of semaglutide in the United States. FDA labeling shows the tablet is approved for adults with obesity, or adults with overweight who have at least one weight-related comorbid condition. ### When did the FDA actually approve the pill? The FDA approval letter for Wegovy tablets says the application was approved effective on the date of the letter, which was tied to Novo Nordisk’s filing for the tablet formulation. A later FDA supplement approval dated January 5, 2026 aligned the labeling for Wegovy injection and Wegovy tablets, confirming the oral product was part of the approved Wegovy franchise. (accessdata.fda.gov) JAMA Medical News reported the FDA approved oral semaglutide for weight reduction in late December 2025, and a New England Journal of Medicine clinician update also described the approval as occurring in December 2025. Those accounts match the FDA records showing the product was approved before the January 2026 labeling alignment. ### Who can get the new oral version? (accessdata.fda.gov) FDA prescribing information says Wegovy tablets are indicated with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight and at least one weight-related comorbid condition. The same labeling also includes a cardiovascular risk-reduction indication in adults with established cardiovascular disease and either obesity or overweight. (jamanetwork.com) The tablet is for oral use, while Wegovy injection remains the subcutaneous version. FDA labeling lists a boxed warning about thyroid C-cell tumors based on rodent findings and says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) ### What dose and evidence supported the oral approval? The Lancet published the OASIS 1 phase 3 trial of once-daily oral semaglutide 50 mg in adults with overweight or obesity in 2023. The trial reported a 15.1% mean body-weight reduction under the treatment-policy analysis at 68 weeks for oral semaglutide, compared with 2.4% for placebo. A Novo Nordisk trial backgrounder reported a 17.4% reduction under the trial-product estimand and said gastrointestinal side effects were the most common adverse events. (accessdata.fda.gov) The New England Journal of Medicine later published OASIS 4 data on a 25 mg once-daily oral semaglutide dose in adults with overweight or obesity. NEJM’s summary says the 25 mg dose produced greater mean weight reduction than placebo, and a January 2026 NEJM clinician update said the newly approved maintenance dose for weight reduction is 25 mg daily. (thelancet.com) ### How does this fit with Novo Nordisk’s broader semaglutide lineup? Novo Nordisk’s U.S. news archive said on May 1, 2026 that its Ozempic pill was becoming available in the United States for adults with type 2 diabetes, describing it as the only FDA-approved oral peptide GLP-1 medicine for that condition. The company separately announced Wegovy HD injection in March and said it was available nationwide in April, expanding the injectable side of its obesity portfolio as well. (nejm.org) JAMA Cardiology said semaglutide remains the only GLP-1 agent with an approved oral formulation and noted recent FDA approval for weight management on January 5, 2026. That leaves Novo Nordisk with the first oral GLP-1 cleared in the United States for obesity treatment, based on currently available FDA and journal records. ### What happens next for doctors and patients? (novonordisk-us.com) FDA’s January 5, 2026 supplement approval letter told Novo Nordisk to submit updated structured product labeling as soon as possible and no later than 14 days after the letter. The agency also required the company to amend pending supplemental applications that include labeling changes so the public labeling repositories reflect the approved text. (jamanetwork.com) Novo Nordisk said in January that the Wegovy pill was broadly available by prescription through more than 70,000 pharmacies nationwide, according to JAMA Medical News. The next concrete step in FDA records was the labeling submission deadline that followed the January 5, 2026 supplement approval. (jamanetwork.com) (accessdata.fda.gov)