Novo Nordisk receives European Commission approval of Wegovy® pill as first oral GLP-1 for weight management in the EU; single, ready-to-use pen for higher dose 7.2 mg also approved

• First GLP-1 pill approved in the European Union for the treatment of obesity and overweight
• Only Wegovy^® pill demonstrates 17%^* mean weight loss¹ and cardiovascular benefits
• Wegovy^® 7.2 mg injection in a single-dose pen, delivering 21%^* weight loss, has now been approved in EU
  
  

Bagsværd, Denmark, 15 July 2026 – Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Wegovy^® pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. This follows the positive opinion issued by the European Medicines Agency 's (EMA) Committee for Medicinal Products for Human Use (CHMP) in May 2026.

The Wegovy^® pill approval is a landmark moment in the treatment of obesity in Europe, making it the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states. It marks the fifth regulatory approval of Wegovy^® pill, after the US, UK, UAE and Bahrain.

“Today’s European Commission approval of Wegovy^® as a once-daily pill brings another important treatment option to people living with obesity,” said Mike Doustdar, president and CEO of Novo Nordisk. “Obesity is a serious chronic disease, and choice can make a real difference. For many people, a tablet may be a simpler and more acceptable way to start and continue treatment. This is more than a regulatory milestone - it is a step toward better and lasting health for people with obesity and a strong societal response to one of Europe’s most significant health challenges.”

The Wegovy^® pill approval is based on the extensive OASIS clinical trial programme, including OASIS 4, which evaluated once-daily oral semaglutide 25 mg in adults with obesity or overweight with at least one weight-related comorbidity. In the trial, oral semaglutide 25 mg demonstrated clinically meaningful and statistically significant weight loss of approximately 17% compared with 3% with placebo when used alongside lifestyle intervention. Around one in three individuals achieved 20% weight loss or more^1*.

The safety and tolerability profile of oral semaglutide is consistent with the established injectable semaglutide profile, which is based on many years of patient experience, with adverse-event–related discontinuations nearly comparable to placebo at 6.9% vs 5.9%^1*.

The European Commission (EC) also granted approval for Wegovy^® 7.2 mg injection in a single-dose pen for people living with obesity.

Wegovy^® pill is currently available in the US, UK and UAE, and Novo Nordisk is committed to launching Wegovy^® pill in more countries in the second half of 2026.

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 comorbidities¹.

About Wegovy^®
Once-weekly Wegovy^® injection (2.4 mg and 7.2 mg) and once-daily Wegovy^® pill (semaglutide
25 mg) are approved by the FDA, EMA and other regulatory authorities worldwide.

In the EU, Wegovy^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with obesity or overweight and in the presence of at least one weight-related comorbidity condition.
In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity 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. It is also indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older, as well in adults with overweight in the presence of at least one weight related comorbid condition. Further, it is approved for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.

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 67,900 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.  

Contacts for further information

_______________________

References

1. Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969. PMID: 40934115.
   
   

* Based on the trial product estimand, i.e. treatment effect if all people adhered to treatment.

Attachment

• PR260715_Wegovy Pill EC approval

© 2026 GlobeNewswire, Inc. All Rights Reserved.

Read More..

The news, reports, views and opinions of authors (or source) expressed are their own and do not necessarily represent the views of CRWE World.