- Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial1
- Wegovy pill is indicated to reduce excess body weight and maintain weight reduction long-term and to reduce the risk of major adverse cardiovascular events*
- Novo Nordisk expects to launch Wegovy pill in the US in early January 2026
Bagsværd, Denmark, 22 December 2025 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events*.
The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management. The approval is based on the OASIS trial programme and the SELECT trial2. In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities1. The weight loss achieved with the Wegovy pill is similar to that of injectable Wegovy 2.4 mg. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial1. The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy pill in the OASIS-4 trial, which was comparable to previous trials with semaglutide for weight management.
"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".
Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.
About the OASIS trial programme
OASIS was a phase 3 clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase 3 programme consisted of four trials, enrolling approximately 1,300 adults with obesity or overweight with one or more comorbidities.
OASIS 4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight with one or more comorbidities.
About Wegovy
Wegovy is now approved as once-daily Wegovy pill (semaglutide tablet 25 mg) and once-weekly Wegovy injection (semaglutide injectable 2.4 mg) by the FDA. The approval of Wegovy pill is based on a New Drug Application to reduce excess body weight in adults with obesity or overweight with at least one weight-related medical condition.
Wegovy is approved as a once-weekly injection by the EMA and widely by other regulatory authorities. The Wegovy pill is currently pending marketing approval from the EMA and other regulatory authorities.
Wegovy is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy injection is indicated to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older, and approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq CopenhagenFacebook, Instagram, X, LinkedIn andYouTube.
Contacts for further information
| Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com (mailto:globalmedia@novonordisk.com) | Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com (mailto:lzsk@novonordisk.com) |
| Investors: | |
| Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com (mailto:jrde@novonordisk.com) | Sina Meyer +45 3079 6656 azey@novonordisk.com (mailto:azey@novonordisk.com) |
| Max Ung +45 3077 6414 mxun@novonordisk.com (mailto:mxun@novonordisk.com) | Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com (mailto:cftu@novonordisk.com) |
| Alex Bruce +45 34 44 26 13 axeu@novonordisk.com (mailto:axeu@novonordisk.com) | Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com (mailto:fptr@novonordisk.com) |
Company announcement No 39 / 2025
*CV death, non-fatal myocardial infarction, or non-fatal stroke
1Based on the trial product estimand: treatment effect if all people adhered to treatment
2Supported with data from the STEP trial programme and the PIONEER PLUS trial
Attachment
- CA251222-Oral-sema-FDA-approval (https://ml-eu.globenewswire.com/Resource/Download/196625f0-ac22-4f02-8b59-1b78a6093847)
