Novo Nordisk (NYSE: NVO) gains FDA nod for Wegovy oral pill for obesity
Rhea-AI Filing Summary
Novo Nordisk reports that the US FDA has approved the once-daily Wegovy® pill, an oral semaglutide 25 mg tablet, as the first oral GLP-1 therapy for weight management. The pill is approved to reduce excess body weight, help maintain weight loss long term and 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. In the OASIS 4 phase 3b trial, adults with obesity or overweight with at least one comorbidity who adhered to treatment achieved a 16.6% mean weight loss, and about one in three achieved weight loss of 20% or more. The weight loss from the Wegovy® pill was similar to that of injectable Wegovy® 2.4 mg, and the safety profile was consistent with prior semaglutide trials. Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026 and has submitted the oral formulation for obesity to the European Medicines Agency and other regulators where approval is still pending.
Positive
- FDA approval of Wegovy® pill: First once-daily oral GLP-1 therapy for weight management and reduction of major adverse cardiovascular events in adults with obesity or overweight and heart disease.
- Strong efficacy data: In the OASIS 4 trial, adults adhering to oral semaglutide 25 mg achieved 16.6% mean weight loss, with about one in three reaching at least 20% weight loss, similar to injectable Wegovy® 2.4 mg.
- Near-term US launch: Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026, adding an oral option alongside the existing injection formulation.
Negative
- None.
Insights
FDA approval of the Wegovy® pill broadens Novo Nordisk's obesity and cardiovascular risk-reduction franchise.
The FDA has approved Wegovy® pill, a once-daily 25 mg oral semaglutide, as the first oral GLP-1 for weight management and reduction of major adverse cardiovascular events in adults with obesity or overweight and known heart disease. This adds an important new dosage form alongside the existing once-weekly Wegovy® injection and may appeal to patients who prefer pills over injections.
In the OASIS 4 phase 3b trial, adults with obesity or overweight plus comorbidities achieved a
Novo Nordisk plans to launch the Wegovy® pill in the US in early
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
December 22, 2025
________________
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé 1
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
| Form 20-F ☒ | Form 40-F ☐ |
Wegovy® pill approved in the US as first oral GLP-1 for weight management
| · | 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
*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
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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
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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 Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
| Media: | |
| Ambre James-Brown | Liz Skrbkova (US) |
| +45 3079 9289 | +1 609 917 0632 |
| globalmedia@novonordisk.com | lzsk@novonordisk.com |
| Investors: | |
| Jacob Martin Wiborg Rode | Sina Meyer |
| +45 3075 5956 | +45 3079 6656 |
| jrde@novonordisk.com | azey@novonordisk.com |
| Max Ung | Christoffer Sho Togo Tullin |
| +45 3077 6414 | +45 3079 1471 |
| mxun@novonordisk.com | cftu@novonordisk.com |
| Alex Bruce | Frederik Taylor Pitter |
| +45 34 44 26 13 | +1 609 613 0568 |
| axeu@novonordisk.com | fptr@novonordisk.com |
Novo Nordisk A/S Investor Relations | Novo Allé 1 2880 Bagsværd Denmark | Telephone: +45 4444 8888 | www.novonordisk.com |
| Company announcement No 39 / 2025 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| Date: December 22, 2025 |
NOVO NORDISK A/S
Maziar Mike Doustdar Chief Executive Officer |
FAQ
What did Novo Nordisk (NVO) announce about the Wegovy ae pill in the US?
Novo Nordisk announced that the US FDA has approved the once-daily Wegovy ae pill, an oral semaglutide 25 mg tablet, as the first oral GLP-1 receptor agonist for weight management and to reduce the risk of major adverse cardiovascular events in adults with obesity or overweight and known heart disease.
How effective is the Wegovy ae pill according to Novo Nordisk's data?
In the OASIS 4 phase 3b trial, adults with obesity or overweight and at least one comorbidity who adhered to once-daily oral semaglutide 25 mg achieved a 16.6% mean weight loss, and about one in three participants achieved 20% or more weight loss. Novo Nordisk states that this is similar to the weight loss seen with injectable Wegovy ae 2.4 mg.
When will Novo Nordisk (NVO) launch the Wegovy ae pill in the US?
Novo Nordisk expects to launch the Wegovy ae pill in the US in early January 2026, providing a once-daily oral alternative to the existing once-weekly Wegovy ae injection.
For which patients is the Wegovy ae pill indicated?
The Wegovy ae pill is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and at least one weight-related medical condition. It is also 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.
How does the safety profile of the Wegovy ae pill compare to previous semaglutide trials?
Novo Nordisk reports that the safety and tolerability profile of semaglutide was reaffirmed in the OASIS 4 trial for the Wegovy ae pill and was comparable to previous trials of semaglutide for weight management.
What is the regulatory status of the Wegovy ae pill outside the US?
Wegovy ae is already approved as a once-weekly injection by the EMA and other regulators. Novo Nordisk has submitted the once-daily oral semaglutide 25 mg for obesity to the EMA and other regulatory authorities during the second half of 2025, and the Wegovy ae pill is currently pending marketing approval in those regions.
