FDA Approves Wegovy in a Pill, Opening New Front in Obesity Drug Race
Novo Nordisk wins approval for the first oral GLP-1 weight loss medication, launching in January at $149 per month as Eli Lilly races to catch up.
The needle is now optional.
The FDA approved Novo Nordisk's Wegovy pill on Sunday, making it the first oral GLP-1 medication cleared for weight management. The Danish drugmaker plans to launch in early January at $149 per month for the starting dose—a price point that emerged from November negotiations with the Trump administration.
Novo Nordisk's U.S.-listed shares jumped in premarket trading Monday.
The Clinical Results
In the OASIS 4 trial, oral semaglutide 25 mg delivered 16.6% mean weight loss when patients adhered to treatment. One in three participants achieved 20% or greater weight loss—results comparable to injectable Wegovy.
That's a significant milestone. The pill version removes the psychological and practical barriers of weekly injections, potentially expanding the addressable market substantially.
The Catch
There's a tradeoff for convenience. The Wegovy pill must be taken on an empty stomach with a small amount of water, and patients need to wait 30 minutes before eating, drinking, or taking other medications.
That's more demanding than a weekly shot, which patients can administer and forget. Whether the pill's convenience outweighs its daily ritual requirements will vary by patient.
Competition Heating Up
The approval gives Novo Nordisk a head start over Eli Lilly, which is developing its own obesity pill called orforglipron. Lilly's drug is expected to receive FDA clearance by summer.
For Novo, the timing is critical. The company has faced supply constraints on injectable Wegovy and watched Lilly's Zepbound gain ground in the obesity market. An oral option diversifies its portfolio and addresses patients who resist injections.
The Market Opportunity
The obesity drug market is projected to reach $130 billion by 2030. Both companies are racing to serve demand that far exceeds current supply—and to establish dominant positions before generics arrive.
For patients, the approval means more choices. For investors, it means the GLP-1 competition is entering a new phase where convenience may matter as much as efficacy.