The FDA has approved once-daily oral semaglutide 25 mg (Wegovy Pill, Novo Nordisk) as the first GLP-1 agonist pill for weight management. 

The new indication is “to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events,” Novo Nordisk announced in a December 22, 2025, statement.

The Wegovy pill is a higher dose of the oral semaglutide Rybelsus (7 mg and 14 mg), FDA-approved in 2019 for treating type 2 diabetes (T2D) and in October 2025 for cardiovascular risk reduction in those with T2D at high risk. 

The new approval was based on results from Novo Nordisk’s OASIS trial program and the SELECT trial. 

OASIS 4 was a randomized phase 3b trial of 307 participants with overweight/obesity, first reported in November 2024 and published in The New England Journal of Medicine in September 2025. There was a 13.6% weight drop with oral semaglutide at 64 weeks vs just 2.2% with placebo regardless of adherence, and 16.6% vs 2.7% for those who adhered the entire time. Both differences were significant, at P < .0001.

“The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy pill in the OASIS-4 trial, which was comparable to previous trials with semaglutide for weight management,” Novo Nordisk said in the statement. 

The company expects to launch the Wegovy pill for obesity in the US in January 2026. 

Asked to comment, Simeon Taylor, MD, PhD, professor of medicine at the University of Maryland School of Medicine, Baltimore, told Medscape Medical News, “The oral formulation of semaglutide provided impressive weight loss requiring a dose of 25 mg/d, or 175 mg/wk. This dose represents more than 70 times the dose on a weekly basis as compared to subcutaneously administered semaglutide. It is likely that some patients may prefer an oral formulation. However, the large dose may have implications for the challenges to manufacture the amount of drug required to treat all the patients who would benefit from a weight-loss drug.”

A Different Kind of GLP-1 Pill May be Next 

Still awaiting an FDA decision is a different type of oral GLP-1 drug: Eli Lilly’s orforglipron, for both weight management and T2D. It is a once-daily small molecule (nonpeptide) that, unlike semaglutide, can be taken any time of day without restrictions on food and water intake or need for refrigeration. Full phase 3 data for orforglipron in people with both obesity and T2D were reported in November 2025 and for obesity without diabetes in September 2025. 

Lilly has submitted orforglipron for regulatory review for treating overweight/obesity in 2025 and plans to submit for T2D in 2026, the company said in a December 18, 2025, statement. 

The nonpeptide “nutrient-stimulated hormone” molecules in development for obesity such as orforglipron are thought to be easier to manufacture and ship, and to be potentially less costly than semaglutide and other peptide GLP-1s. However, they are also metabolized differently. “A head-to-head trial may be required to compare effectiveness,” Taylor said. 

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social