Novo Nordisk asks FDA to approve a higher dose of Wegovy, 7.2 mg

Novo Nordisk submitted a supplemental New Drug Application to the U.S. Food and Drug Administration on Nov. 26, 2025, seeking approval of a 7.2 mg dose of injectable semaglutide, the drug sold as Wegovy, for chronic weight management in adults with obesity ^[1].

The filing covers use of the higher dose alongside a reduced-calorie diet and increased physical activity ^[1]. The 7.2 mg dose is investigational; the Wegovy injectable dose currently on the market is 2.4 mg ^[1]. The application will be reviewed under the FDA's Commissioner's National Priority voucher (CNPV) pilot, a program that accelerates review for products addressing major national health priorities. Novo Nordisk says review is expected within one to two months after the FDA accepts the filing ^[1]. The company has not disclosed a price for the higher dose or how insurance coverage might work.

What the STEP UP trial found

The application includes results from STEP UP, a 72-week phase 3 trial that randomized 1,407 adults with obesity (BMI of 30 or higher) to once-weekly semaglutide 7.2 mg, semaglutide 2.4 mg or placebo. People with diabetes were excluded ^[1].

Participants started at an average body weight of 249 pounds. Among those who adhered to treatment, average weight loss after 72 weeks was 20.7% with 7.2 mg, compared with 17.5% on 2.4 mg and 2.4% on placebo ^[1]. In that same analysis, 33.2% of people taking 7.2 mg lost 25% or more of their body weight, compared with 16.7% on 2.4 mg and 0.0% on placebo ^[1].

When the trial counted everyone who enrolled, including those who stopped treatment, average weight loss was 18.7% with 7.2 mg, 15.6% with 2.4 mg and 3.9% with placebo ^[1]. In that analysis, 90.7% of the 7.2 mg group lost at least 5% of body weight, compared with 89.9% on 2.4 mg and 36.8% on placebo, and 31.2% of the 7.2 mg group lost 25% or more, compared with 15.3% and 0.0% ^[1].

Gastrointestinal adverse events were more common with 7.2 mg than with 2.4 mg or placebo, as was dysaesthesia, an abnormal burning or prickling sensation ^[1]. Serious adverse events were reported by 6.8% of participants on 7.2 mg, 10.9% on 2.4 mg and 5.5% on placebo ^[1]. The trial results were presented in a poster at the American Diabetes Association's 85th Scientific Sessions in Chicago in June 2025 ^[1].

"If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential," said Anna Windle, PhD, senior vice president for clinical development, medical and regulatory affairs at Novo Nordisk ^[1].

Why it matters for patients

For people already taking semaglutide, the filing points to a possible third step above the 2.4 mg dose. In the trial, the extra average weight loss from 7.2 mg over 2.4 mg was about 3 percentage points in the adherence analysis, and the share of people reaching 25% weight loss roughly doubled ^[1].

The data also show that the higher dose did not work the same way for everyone. On 7.2 mg, about two-thirds of participants in the adherence analysis did not reach 25% weight loss, and gastrointestinal side effects were more frequent than at 2.4 mg ^[1]. Because STEP UP excluded people with diabetes, the results do not directly describe how the 7.2 mg dose performs in that group ^[1].

Nothing in the filing suggests the 2.4 mg dose is being withdrawn, and the company has not said whether people currently on 2.4 mg could move to 7.2 mg, or under what conditions. That has not been reported.

What happens next

The FDA must first accept the filing; after that, Novo Nordisk expects a review decision within one to two months under the CNPV pilot ^[1]. The 7.2 mg dose is also under review by the European Medicines Agency, in the UK and in several other countries, with an EU decision expected in the first quarter of 2026 ^[1]. Whether the higher dose wins approval in the US, and when it would reach pharmacies, has not been disclosed.