Novo Nordisk’s Oral Wegovy Gains FDA Approval, 25mg Semaglutide Tablet Launches for Weight Management

The U.S. Food and Drug Administration approved Novo Nordisk’s Wegovy oral tablet, containing 25 mg of semaglutide, for weight management in adults, with the launch expected in early January 2026. The approval was based on the OASIS 4 trial, which showed an average weight loss of about 17% among participants using the daily pill alongside lifestyle interventions, officials said.

The approval marks the first time the FDA has authorized an oral glucagon-like peptide-1 (GLP-1) receptor agonist specifically for weight management in adults, officials said. The FDA’s decision was based on data from the OASIS 4 clinical trial, which included 307 participants randomized in a 2:1 ratio to receive either the 25 mg semaglutide oral tablet or placebo, alongside lifestyle interventions involving diet and physical activity, according to Novo Nordisk. The trial’s 64-week treatment period incorporated a 12-week dose escalation protocol, with participants achieving an average weight loss of approximately 17% if they remained on the 25 mg dose throughout the study. When accounting for all participants regardless of adherence, the average weight loss was about 14%, company records show.

Participants achieving an average weight loss of approximately 17% if they remained on the 25 mg dose throughout the study.

The OASIS 4 trial excluded individuals with diabetes and included a seven-week off-treatment follow-up phase, according to the FDA’s review documents. The safety profile observed was consistent with known semaglutide side effects, including gastrointestinal symptoms such as nausea, vomiting, diarrhea, constipation, and abdominal pain, the agency noted. Reports of altered skin sensation were more frequent at higher doses but generally resolved over time, officials added. The FDA has issued a boxed warning highlighting the risk of thyroid C-cell tumors based on rodent studies, although the relevance to humans remains unknown, according to prescribing information.

Novo Nordisk plans to launch the oral Wegovy tablet in the United States in early January 2026, with an initial 1.5 mg starting dose priced at $149 per month, company representatives confirmed. The 25 mg once-daily dose will be available following the dose escalation period outlined in the clinical trial. The tablets are produced domestically in the U.S., ensuring a robust supply at launch, according to company sources. Novo Nordisk emphasized that concomitant use of oral Wegovy with other semaglutide products or GLP-1 receptor agonists is not recommended due to potential safety concerns and lack of additional benefit, the FDA prescribing information states.

Timothy Garvey, MD, a professor at the University of Alabama at Birmingham, commented on the approval, saying it equips healthcare professionals with more options to tailor weight management treatments for patients. “Oral Wegovy expands the delivery formats of semaglutide, providing additional flexibility for patients and clinicians,” Garvey said in a statement provided by Novo Nordisk. The company highlighted that the approval broadens patient choices in managing excess weight and underscores the ability to meet diverse patient needs with efficacious therapies.

Wegovy is indicated for adults with obesity or overweight who have at least one weight-related comorbidity, such as hypertension or type 2 diabetes, and is intended to be used in conjunction with a reduced-calorie diet and increased physical activity, according to FDA labeling. The medication is also approved to reduce the risk of major cardiovascular events in certain adults and carries an accelerated approval for treating metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis. Healthcare providers are advised to monitor blood glucose levels in patients with diabetes before and during treatment with Wegovy tablets.

The FDA’s approval of the oral semaglutide tablet adds to the existing portfolio of semaglutide products, which includes injectable formulations previously approved for weight management and diabetes treatment. The original approval for Wegovy injection dates back to 2017, and the oral tablet represents an extension of that indication, officials said. The prescribing information now covers both the injectable and oral formulations, providing guidance on dosing, safety, and contraindications.

Regulatory authorities emphasized that the oral Wegovy tablet is currently approved only in the United States. The approval followed a separate authorization of Wegovy HD injection (7.2 mg) under the Critical to New Product Vitality (CNPV) program, which expedites review of innovative therapies addressing critical health priorities, according to FDA announcements. The CNPV program aims to facilitate faster access to treatments that improve affordability and patient outcomes.

Post-approval monitoring will continue to assess the safety profile of oral semaglutide, including reports of skin reactions that the FDA is investigating further. The agency also advises against combining oral Wegovy with other GLP-1 receptor agonists to minimize risks. As the medication becomes available, healthcare professionals will have an additional therapeutic option to support patients in achieving and maintaining weight loss, officials said.