- FDA approved Wegovy HD (semaglutide 7.2 mg) and awarded a Commissioner’s National Priority Voucher
- In the 72-week STEP UP trial (~1,400 participants) semaglutide 7.2 mg produced 20.7% mean weight loss and 31.2% of participants achieved ≥25% loss
- In the 72-week STEP UP T2D trial (~500 participants) semaglutide 7.2 mg produced 14.1% mean weight loss
- US launch of Wegovy HD in a single-dose pen is expected April 2026
Approval and launch
The US FDA granted accelerated approval for Wegovy HD (once‑weekly semaglutide 7.2 mg) to reduce excess body weight and maintain long‑term weight reduction and awarded a Commissioner’s National Priority Voucher; US launch in a single‑dose pen is expected April 2026.
STEP UP trial outcomes
The 72‑week STEP UP trial (~1,400 participants) showed a 20.7% mean weight loss (efficacy estimand) with 31.2% of participants achieving ≥25% loss; the 72‑week STEP UP T2D trial (~500 participants) showed a 14.1% mean loss; treatment‑regimen estimands were 18.7% and 13.2%, respectively.
Safety and product positioning
Safety and tolerability for semaglutide 7.2 mg were consistent with prior semaglutide weight‑management trials; Wegovy HD is positioned as a higher‑dose injectable complement to existing Wegovy 2.4 mg therapy.
Regulatory status and indications
Semaglutide 7.2 mg is already approved for adults with obesity in the EU and UK, with further EU/UK decisions on a single‑dose pen expected in H2 2026; FDA labels for Wegovy include weight reduction and maintenance in adults with obesity or overweight plus comorbidity, pediatric use from age 12, FDA approval to reduce major adverse cardiovascular events in adults with known heart disease and obesity/overweight, and approval for MASH in adults with moderate to advanced fibrosis (excluding cirrhosis).
