FDA approved the first daily Wegovy tablet to treat obesity. The 25 mg semaglutide pill produced an average 13.6% weight loss in trials over ~15 months, close to injectable results. The tablet requires morning dosing on an empty stomach with a 30-minute wait before eating to allow a protective ingredient to work. Novo Nordisk expects availability within weeks and some providers will offer a starter dose for $149/month, potentially widening access and lowering costs.
FDA Approves Wegovy Oral Pill — First Daily Tablet for Obesity, Promising Wider Access and Lower Costs
FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File)
The U.S. Food and Drug Administration has approved a daily oral version of Wegovy, making it the first tablet authorized to treat obesity. The decision gives Novo Nordisk an early commercial advantage over rival Eli Lilly, whose oral candidate, orforglipron, remains under FDA review.
What the Approval Means
The newly approved Wegovy pill contains 25 mg of semaglutide, the same active ingredient found in the injectable drugs Wegovy and Ozempic and in Rybelsus, a lower-dose oral semaglutide approved for diabetes. Novo Nordisk says the tablets should be available within weeks.
Clinical Results
In clinical trials, participants taking oral Wegovy lost an average of 13.6% of total body weight over about 15 months, compared with a 2.2% average loss for those on placebo — results nearly equivalent to the injectable Wegovy (~15% average loss).
Lilly’s highest-dose oral candidate, orforglipron, produced an average weight loss of 11.2% over nearly 17 months in trials. By comparison, Lilly’s injectable Zepbound (tirzepatide), which targets both GLP-1 and GIP hormones, achieved roughly 21% average weight loss in trials.
Dosage, Convenience and How the Pill Works
The Wegovy tablet must be taken in the morning on an empty stomach with a small sip of water, followed by a 30-minute wait before eating or drinking. Novo Nordisk added a protective ingredient so the semaglutide can survive the stomach long enough to be absorbed. Lilly says its oral candidate has no such dosing restrictions.
Side Effects and Safety
Oral and injectable GLP-1 drugs share common side effects, most often nausea and diarrhea. Patients should discuss potential risks and benefits with their clinicians.
Cost and Access
Pills are generally cheaper to produce than injectables, which could lower treatment costs and broaden access. Novo Nordisk said some providers will offer a starting dose for $149 per month, with more pricing details expected in January. Earlier this year, U.S. officials said they had engaged manufacturers to negotiate lower prices for GLP-1 drugs, which can otherwise cost more than $1,000 per month.
Voices From Experts and Patients
“There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, an obesity specialist at Massachusetts General Hospital. “It’s not just about who gets there first; it’s about having options.”
Chris Mertens, a trial participant and pediatric pulmonologist, reported losing about 40 pounds on the Wegovy pill and described reduced appetite and intrusive food thoughts. After the trial ended and some weight returned, he switched to an injectable GLP-1.
Market Impact
About 100 million Americans live with obesity; roughly 1 in 8 have used injectable GLP-1 drugs, according to KFF. The availability of an effective daily pill could broaden the pool of patients able to access treatment and expand the fast-growing market for weight-loss therapies.
Regulatory Note: Lilly’s orforglipron is being reviewed under an FDA priority program that aims to speed approvals; a decision was expected by spring.
Reporting adapted from the Associated Press. The AP is solely responsible for all content.
