US EditionNovo Nordisk wins US approval for weight-loss pill
The FDA approved the first oral GLP-1 pill for obesity, showing 16.6% average weight loss in trials, with U.S. launch planned for January 2026 by Novo Nordisk.
- 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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The US FDA has approved the weight loss drug Wegovy in pill form, marking a new era for weight loss drugs that have previously been available in injectable form.
Danish pharmaceutical giant Novo Nordisk announced on Monday that the U.S. Food and Drug Administration (FDA) has approved tablets of its popular GLP-1 anti-obesity drug Wegovy for weight loss.
The FDA has now given the nod to Novo Nordisk's drug, which could hit shelves in the United States in 2026.
FDA approves first weight-loss pill
The Food and Drug Administration approved the first-ever weight-loss pill on Monday, a move that is set to greatly expand the industry. Novo Nordisk’s GLP-1 weight-loss pill is a tablet formulation of the popular Ozempic and Wegovy. The drugs previously could only be taken via injection, a discomforting method for many users. Its transformation into a convenient pill is almost certain to lead to increased usage of the drug. In its announcement, …
Tablets are not only cheaper, but also easier for many people to use in their daily lives than weight-loss injections. However, pills also have their drawbacks.
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