With a planned US launch in early 2026, the approval expands treatment options following strong late-stage trial results.
History has been made, as the FDA has officially approved Novo Nordisk’s Wegovy pill (a once-daily oral semaglutide 25 mg), intended to limit excess body weight and help with weight maintenance.1
This new version of Wegovy in pill form represents the first ever oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy that’s been approved for weight management. It also now marks the third formulation of Wegovy, expanding its available options.2
The industry may recall that the GLP-1 agonist was initially approved in June 2021 for chronic weight management in adults with obesity or overweight who have at least one related condition, such as hypertension, type 2 diabetes, or high cholesterol, alongside diet and exercise. In 2024, its label was further expanded to include adults with cardiovascular disease.
The approval is linked to results pertaining to both the OASIS trial program and the SELECT trial.1 The OASIS 4 trial—a 64-week, phase IIIb program—indicated that oral semaglutide 25 mg consumed once daily resulted in 16.6% mean weight loss when the treatment was followed by adult participants with either obesity or overweight with one or more comorbidities. One in three participants also saw 20% or greater weight loss, and Novo notes that the weight loss is comparable to what was achieved via Wegovy’s injectable 2.4 mg version.
As for the pill, it’s expected to hit the US market in January 2026. The company sought approval from the European Medicines Agency, along with other regulatory bodies—during H2 2025.
“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,” commented Mike Doustdar, Novo Nordisk’s president and CEO. “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovypill 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.”
It’s also expected that customers will also be able to order the new oral GLP-1 via WeightWatchers shortly thereafter, as the telehealth company indicated this past November.
"We have been working with Novo Nordisk ahead of time to support the launch of oral weight-loss medication," Tara Comonte, the company’s CEO, commented to Reuters.3 "A lot of people don't want an injection. And the convenience of a pill is going to be huge," she said.
For those who prefer the injectable version, Wegovy was one of various products that was added to the Commissioner’s National Priority Voucher (CNPV) program, an initiative that tackles public health and national security priorities.4
Per this pilot CNPV program, qualifying sponsors can obtain a voucher that allows the FDA to complete its review in as little as one to two months, compared to the standard 10–12-month review window that normally follows the final submission process.
References
1. Novo Nordisk A/S: Wegovy pill Approved in the US as First oral GLP-1 for weight management. Novo Nordisk. December 22, 2025. Accessed December 23, 2025.
2. Jacobus N. FDA Approves Novo Nordisk’s Wegovy Pill for Weight Management. Pharmaceutical Executive. December 22, 2025. Accessed December 23, 2025.
3. Saraceno N. WeightWatchers to Offer Novo Nordisk’s Oral Wegovy, if Approved Next Year. Pharmaceutical Commerce. November 13, 2025. Accessed December 23, 2025.
4. James D. FDA Continues to Expand National Priority Voucher Program. Pharmaceutical Executive. November 7, 2025. Accessed December 23, 2025.
