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By Anna Commander and Simon Crerar
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The U.S. Food and Drug Administration (FDA) has approved its first oral glucagon-like peptide (GLP)-1 pill for weight management, a news release from Novo Nordisk announced on Monday.
The pill, Wegovy, is a once-daily oral semaglutide of 25 mg used to "reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events," Novo Nordisk says in part.
The press release notes that in an OASIS 4 trial, participants taking the oral semaglutide of 25 mg saw a 16.6 percent mean weight loss while "treatment was adhered to."
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Why It Matters
Until now, the most widely used GLP-1 medicines for weight loss have been injections. Novo Nordisk is pitching the newly approved Wegovy pill as a more convenient, once-daily option that could broaden uptake — especially among patients who prefer not to use injectables.
There has been intense demand for GLP-1 medications and the industry-wide push toward oral versions that may be easier for some patients to start and stay on: the moniker "Ozempic 2.0" has been floating around on social media as a trending nickname for the next generation of weight loss drugs in the works for 2026.
What To Know
Novo Nordisk said the Wegovy pill is approved “to reduce excess body weight and maintain weight reduction long term” and “to reduce the risk of major adverse cardiovascular events.”
The company said the approval is based on its OASIS trial program and the SELECT trial. n the OASIS 4 trial, adults with obesity — or overweight with at least one comorbidity — who took oral semaglutide 25 mg once daily achieved a 16.6 percent mean weight loss “when treatment was adhered to,” Novo Nordisk said.
The company also said one in three trial participants experienced 20 percent or greater weight loss, and that the safety and tolerability profile was consistent with prior semaglutide trials.
In earlier reporting on the race to develop effective weight-loss tablets, experts told Newsweek that oral options could appeal to people who are reluctant to inject a medication and could help expand treatment overall.
What People Are Saying
Novo Nordisk President and CEO Mike Doustdar: "The pill is here...patients will have a convenient, once daily pill that can help them lose as much weight as the original injection. The pill provides a new, convenient treatment option that can help patients start or continue their weight loss journey."
Novo Nordisk's stock soared in after hours trading:
What Happens Next
Novo Nordisk said it expects to launch Wegovy pill in the U.S. in early January 2026. The company submitted oral semaglutide 25 mg to the European Medicines Agency and other regulators in the second half of 2025.
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