Novo Nordisk (NVO) announced that the FDA has approved Wegovy HD (semaglutide 7.2 mg), a higher-dose, once-weekly injectable version of its blockbuster obesity drug Wegovy, offering patients an average of 20.7% weight loss based on results from the STEP UP trial. The company expects to launch the new single-dose pen in the U.S. in April 2026.
Wegovy HD is the first GLP-1 therapy to receive approval under the FDA Commissioner's National Priority Voucher pilot program, which accelerates review for products addressing major U.S. health priorities. The new dose complements the existing 2.4 mg formulation already approved for chronic weight management and cardiovascular risk reduction.
Wegovy (semaglutide) was first approved by the FDA in June 2021 as an injectable treatment for chronic weight management in adults with obesity or overweight.STEP UP Trail Results
In the pivotal 72-week STEP UP and STEP UP T2D trials, Wegovy HD was evaluated in adults with obesity with or without type 2 diabetes. The higher dose formulation delivered 20.7% mean weight loss, with about one-third of patients achieving =25% weight loss.
Wegovy continues to be one of Novo Nordisk's strongest growth drivers. In 2025, sales within obesity and diabetic care rose 7%, driven largely by obesity-care growth 26%. Wegovy pill prescriptions reached approximately 50,000 weekly shortly after its January 2026 launch of the oral formulation.
Novo Nordisk said the approval of Wegovy HD strengthens its obesity portfolio as competition intensifies and pricing pressure increase in the U.S. market. The company expects the new higher-dose option to help more patients achieve meaningful weight-loss goals and expand overall treatment.
Wegovy 7.2 mg is already approved for adults with obesity in the EU and the UK. Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.
NVO has traded between $35.85 and $81.44 over the past year. The stock closed Thursday's trading at $37.08, down 0.99%. During the overnight trading, the stock rose to $37.37, up 0.78%.
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