The U.S. FDA has approved Novo Nordisk’s Wegovy HD (semaglutide 7.2 mg), a once-weekly injectable therapy for long-term weight management, after Phase 3 STEP UP trials showed up to 20.7% mean weight loss in adults with obesity.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
U.S. Food and Drug Administration has approved Wegovy® HD (semaglutide 7.2 mg) from Novo Nordisk for reducing excess body weight and maintaining long-term weight loss in adults with obesity or overweight. The once-weekly injectable therapy received a Commissioner’s National Priority Voucher, accelerating its regulatory review and highlighting its potential role in addressing major public health needs in the United States.
Novo Nordisk filed sNDA for Wegovy HD (semaglutide 7.2 mg) with the U.S. Food and Drug Administration in November 2025.
The approval is based on data from the Phase 3 STEP UP clinical trial programme (NCT05646706), which evaluated the efficacy and safety of higher-dose semaglutide. In the 72-week STEP UP trial, participants with obesity receiving semaglutide 7.2 mg achieved a mean weight reduction of 20.7%, while nearly one-third of patients experienced at least 25% weight loss. In the STEP UP T2D trial, which enrolled adults with obesity and type 2 diabetes, the therapy produced a mean weight loss of 14.1%.
Across both trials, the safety and tolerability profile of semaglutide 7.2 mg remained consistent with previously reported data for semaglutide-based weight management therapies.
“Since its launch in 2021, Wegovy has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and cardiometabolic benefits, including reductions in cardiovascular risk,” said Mike Doustdar. He noted that the new higher-dose option is expected to deliver approximately 21% average weight loss, expanding treatment choices for people with obesity.
Novo Nordisk plans to launch Wegovy HD in the United States in April 2026, supplied in a single-dose pen for once-weekly administration.
Regulatory momentum for the higher-dose formulation is also expanding internationally. Semaglutide 7.2 mg is already approved for adults with obesity in the European Union and the United Kingdom, and the company expects additional regulatory decisions for the single-dose pen formulation in the second half of 2026.
Novo Nordisk’s latest approval further expands the Wegovy franchise, which has rapidly become one of the company’s key growth drivers in the global obesity treatment market. The introduction of a higher-dose injectable formulation follows the recent rollout of the oral Wegovy pill in the United States and reflects Novo Nordisk’s strategy to broaden treatment options and sustain strong demand for semaglutide-based therapies. With weight loss approaching 21% in clinical trials, the 7.2 mg formulation could further strengthen Wegovy’s commercial momentum as demand for incretin-based obesity medicines continues to rise worldwide.
Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist, is approved as a once-weekly injection for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity. In the US, it is also approved to reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or cardiovascular death in adults with obesity or overweight and established cardiovascular disease, and for weight management in pediatric patients aged 12 years and older.
References
Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss, 19 March 2026, News Details
Wharton S, Freitas P, Hjelmesæth J et al., Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial, The Lancet Diabetes & Endocrinology, 2025; 13, 949-963, https://doi.org/10.1016/S2213-8587(25)00226-8
A Research Study to See How Semaglutide Helps People with Excess Weight, Lose Weight (STEP UP) (STEP UP), ClinicalTrials.gov ID NCT05646706, https://clinicaltrials.gov/study/NCT05646706
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.