Novo Nordisk Seeks FDA Approval for Higher-Dose Semaglutide 7.2 mg for Chronic Weight Management

Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a higher-dose formulation of semaglutide injection 7.2 mg (Wegovy®) for chronic weight management in adults with obesity. The investigational dose would be used in combination with reduced-calorie diet and increased physical activity. Review of the filing will occur under the FDA Commissioner’s National Priority Voucher (CNPV) pilot, which is designed to accelerate evaluation of products addressing major national health priorities. Review is expected within 1–2 months following FDA acceptance of the submission.

“Our pipeline is rapidly expanding to meet the needs of people living with obesity,” Anna Windle, PhD, senior vice president, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said in a press release. She noted that the expedited review reflects the program’s potential to expand treatment options.

Phase 3 STEP UP Findings: Higher Dose Produced Greater Weight Loss

The sNDA includes data from the STEP UP trial, a 72-week, randomized, double-blind, placebo- and active-controlled phase 3 study evaluating semaglutide 7.2 mg vs placebo and semaglutide 2.4 mg in 1 407 adults with obesity and without diabetes. Participants received lifestyle intervention in addition to study treatment.

Key findings include:

• Mean baseline weight: 249 lb
• Mean weight loss with semaglutide 7.2 mg: 20.7% at 72 weeks (trial product estimand)
• Comparators: 17.5% with semaglutide 2.4 mg; 2.4% with placebo
• When accounting for discontinuations (treatment policy estimand), weight loss was 18.7% with semaglutide 7.2 mg vs 15.6% with semaglutide 2.4 mg and 3.9% with placebo
• ≥5% weight loss: 90.7% with semaglutide 7.2 mg; 89.9% with semaglutide 2.4 mg; 36.8% with placebo
• ≥25% weight loss: 33.2% (trial product estimand) and 31.2% (treatment policy estimand) with semaglutide 7.2 mg compared with 16.7% and 15.3% with semaglutide 2.4 mg; 0.0% with placebo

Gastrointestinal adverse events were more frequent with semaglutide 7.2 mg than with semaglutide 2.4 mg or placebo, as was dysaesthesia. Serious adverse events occurred in 6.8% of participants receiving semaglutide 7.2 mg, 10.9% of those receiving semaglutide 2.4 mg, and 5.5% of those receiving placebo.

Regulatory Status and Next Steps

The 7.2 mg dose is also under review by the European Medicines Agency, the UK, and several additional regulatory authorities. A decision in the EU is expected in early 2026.

Novo Nordisk noted that obesity remains a chronic, progressive disease shaped by biological, genetic, environmental, and social factors, requiring long-term management and individualized treatment approaches.

Reference: Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg. News release. Novo Nordisk. November 26, 2025. Accessed November 26, 2025. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916464#