FDA Approves Novo Nordisk’s Wegovy Pill for Weight Management
Key Takeaways
- Wegovy pill is the first oral GLP-1 receptor agonist approved for weight management, offering a convenient alternative to injections.
- FDA approval is based on successful OASIS and SELECT trials, showing significant weight loss and safety.
The approval marks the first agency-cleared oral formulation of a GLP-1 drug for obesity.
The FDA has approved Novo Nordisk’s Wegovy pill to reduce excess body weight, support weight management, and maintain weight reduction long term, reducing the risk of major cardiovascular events.
This marks the third formulation of Wegovy to be approved by FDA. The agonist was initially cleared in June 2021 for chronic weight management in those with obesity or overweight and at least one weight-related condition, including high blood pressure, type 2 diabetes, or high cholesterol, in addition to diet and increased exercise. In 2024, the FDA approved an
The Wegovy pill’s approval as the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy cleared for weight management ends the race between Novo and other company’spushing their similar versions for approval, such as Eli Lilly’s, which recently announced
On the heels of the approval announcement, Novo Nordisk shares jumped 7%.2
What is FDA’s approval based on?
The Wegovy pill’s approval is based on results gathered during both the OASIS trial program and the SELECT trial.1
OASIS was a Phase III clinical development program for once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical Phase III program was comprised of four trials that enrolled an estimated 1,300 adults with obesity or overweight with one or more comorbidities. The OASIS 4 trial was a Phase IIIb study conducted over a 64-week period, evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight with one or more comorbidities.1
During the OASIS 4 trial, the Wegovy pill (oral semaglutide 25 mg) taken once daily demonstrated a 16.6% mean weight loss when administered in adult participants diagnosed with obesity or as being overweight and having one or more comorbidities.1
The weight loss achieved with the Wegovy pill is comparable to that of the injectable version of Wegovy 2.4 mg, with one in three people experiencing 20% or greater weight loss in the OASIS 4 trial.
Wegovy’s previously established safety and tolerability profile was reaffirmed with the Wegovy pill in the OASIS-4 trial, including comparable results to previous trials with semaglutide for weight management.1
“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,” said Mike Doustdar, president and CEO of Novo Nordisk. “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US.”
When will the Wegovy pill be available?
Novo Nordisk is expecting to launch the oral formulation in the US market in early January 2026, and submitted the pill version for approval in the European Medicines Agency (EMA) and other regulatory authorities during the second half of this year.1
Sources
1. Novo Nordisk A/S: Wegovy pill approved in the US as first oral GLP-1 for weight management Novo Nordisk December 22, 2025
2. Novo Nordisk Jumps 7% After FDA Approves First Ever GLP-1 Pill Yahoo Finance December 23, 2025
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