FDA Approves First Oral GLP-1 Receptor Agonist for Chronic Weight Management

The US FDA has approved once-daily oral semaglutide 25 mg for chronic weight management and long-term weight maintenance in adults with obesity or overweight, Novo Nordisk announced December 22, 2025. The oral formulation is also approved to reduce the risk of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, in eligible adults.

According to Novo Nordisk, the approval makes oral semaglutide the first oral glucagon-like peptide-1 receptor agonist therapy approved in the United States for weight management. The decision was based on data from the OASIS clinical trial program and the cardiovascular outcomes SELECT trial.

In the phase 3b OASIS 4 trial, once-daily oral semaglutide 25 mg demonstrated a mean weight loss of 16.6% among adults with obesity or overweight and at least one weight-related comorbidity when treatment was adhered to, based on the trial product estimand. The company reported that weight loss achieved with the oral formulation was similar to that observed with the once-weekly injectable semaglutide 2.4 mg. In OASIS 4, one in three participants experienced at least 20% weight loss.

The safety and tolerability profile of oral semaglutide in OASIS 4 was reported to be consistent with prior trials of semaglutide for weight management. Novo Nordisk stated that no new safety signals were identified in the trial.

“The pill is here. With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” Mike Doustdar, president and CEO of Novo Nordisk, said in the company announcement.

Novo Nordisk expects to launch the oral formulation in the US in early January 2026. The company has also submitted once-daily oral semaglutide 25 mg for obesity to the European Medicines Agency and other regulatory authorities during the second half of 2025.

The OASIS program was a global phase 3 clinical development program evaluating oral semaglutide 25 mg and 50 mg in adults with obesity or overweight and one or more comorbidities. The program consisted of 4 trials enrolling approximately 1 300 participants. OASIS 4 enrolled 307 adults and compared oral semaglutide 25 mg with placebo over 64 weeks.

With the current approval, semaglutide is now available in the US as both a once-daily oral formulation for weight management and a once-weekly injectable formulation. The oral formulation is approved for adults with obesity or overweight and at least one weight-related medical condition, and to reduce the risk of major adverse cardiovascular events in adults with known cardiovascular disease who also have obesity or overweight, according to Novo Nordisk.

Reference: Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management. News release. Novo Nordisk. December 22, 2025. Accessed December 23, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472#