FDA Approves Novo Nordisk’s Wegovy® HD For Long-Term Weight Management, Delivers Up To 20.7% Weight Loss; US Launch Planned For April 2026

Novo Nordisk announced that the U.S. Food and Drug Administration has approved Wegovy® HD, a once-weekly injectable formulation of semaglutide 7.2 mg, for chronic weight management and long-term weight maintenance. The therapy also received a Commissioner’s National Priority Voucher, expediting its regulatory review and highlighting its relevance to major public health needs in the United States.

The approval is supported by findings from the STEP UP clinical programme. In the STEP UP trial involving people with obesity, once-weekly semaglutide 7.2 mg achieved an average weight reduction of 20.7%, with roughly one-third of participants losing at least a quarter of their body weight. In the STEP UP Type 2 diabetes study, participants with both obesity and type 2 diabetes achieved a mean weight loss of 14.1%.

“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO of Novo Nordisk. “Earlier this year, we launched the Wegovy® pill, and with the accelerated approval of Wegovy® HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”

Safety outcomes were consistent with the established tolerability profile of semaglutide used in earlier weight management studies. The higher-dose formulation did not reveal new safety concerns and demonstrated tolerability comparable to that of previous semaglutide regimens.

Novo Nordisk plans to introduce Wegovy® HD in the United States in April 2026 using a single-dose pen presentation. The 7.2 mg dose is already authorized in the European Union and the United Kingdom for adults with obesity, and additional regulatory decisions regarding the single-dose pen format are anticipated in those regions in the second half of 2026.