FDA Approves First Daily Pill for Weight Loss Treatment
The FDA approved the first daily oral GLP-1 drug for weight management, with clinical trials showing up to 16.6% average weight loss, expanding treatment options for adults with obesity.
- On Dec. 22, 2025 the U.S. Food and Drug Administration approved a pill version of Wegovy, Novo Nordisk A/S's first oral GLP-1 therapy cleared for weight management in the United States.
- In the 64-week OASIS 4 trial, 307 adult participants randomized to oral semaglutide 25 mg showed mean weight loss of about 17% when treatment was adhered to.
- Among trial participants, 76% achieved at least 5% weight loss; a 1.5 mg starting dose will be available in early January for $149 per month, and production is underway at Novo Nordisk North Carolina manufacturing sites.
- Novo Nordisk plans a U.S. launch in early January 2026, including an indication to reduce major adverse cardiovascular events, while pricing and demand remain key market factors.
- Facing competition from Eli Lilly, Novo Nordisk struggles to regain share as more patients choose Zepbound, while it argues a convenient GLP-1 pill without cold storage could boost interest but unclear if market share will rise.
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Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss
Beyond weight reduction and long-term maintenance of weight loss, the FDA decision for oral Wegovy covers use of the once-daily pill for reducing the risk of major cardiovascular events. Novo Nordisk expects the Wegovy tablet will launch in early January. The post Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss appeared first on MedCity News.
Novo Nordisk Strikes First With Oral Wegovy -- But Can It Outrun Lilly's Looming Pill?
Quick Read Novo Nordisk (NVO) received FDA approval for the first oral Wegovy pill. The once-daily tablet delivered 16.6% average weight loss over 64 weeks. Novo Nordisk priced the oral Wegovy at $149 per month for the lowest dose. The injectable version costs $349 monthly. Eli Lilly could win approval for its oral GLP-1 drug orforglipron in early 2026. Lilly’s injectables have already captured market share from Novo Nordisk despite launching…
The U.S. Food and Drug Administration (FDA) has approved a tablet version of its weight-loss drug Wegovy, according to pharmaceutical giant Novo Nordisk. It is the first such tablet to receive regulatory approval and could usher in a new era in the history of weight-loss drugs. Wegovy's Danish maker, Novo Nordisk, said the once-daily tablet is a "convenient alternative" to the weekly injectable drug and produces the same weight loss. The approva…
The U.S. Food and Drug Administration Agency has approved the use in pill form of Wegovy slimming drug from the pharmaceutical company...
An approval from the US Food and Drug Administration (FDA) of Novo Nordisk's weight loss drug Wegovy in pill form left its mark on the share today. The status at the close of trading is an increase of 9.2 pc...
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