The European Commission (EC) has granted marketing authorization to Novo Nordisk for a new, higher dosage of Wegovy (semaglutide) for the treatment of obesity in adults. The approval, announced on February 17, 2026, introduces a 7.2 mg once-weekly maintenance dose, significantly increasing the therapeutic ceiling from the previously approved 2.4 mg standard. This regulatory milestone makes the 7.2 mg dose the highest approved strength of semaglutide for weight management to date, positioning it as a potent option for patients requiring additional efficacy. The approval is based on clinical data demonstrating that the 7.2 mg dose can deliver weight loss approaching outcomes seen with bariatric surgery.
The new 7.2 mg dose is indicated for chronic weight management in adults with a Body Mass Index (BMI) of ≥30 kg/m² (obesity), or ≥27 kg/m² (overweight) in the presence of at least one weight-related comorbidity. Currently, the 7.2 mg dose is administered as three 2.4 mg injections in a single sitting, though Novo Nordisk has applied for a single-dose pen device which may become available later in 2026. The approval allows physicians to escalate treatment to 7.2 mg for patients who have not achieved sufficient weight loss on the standard 2.4 mg maintenance dose. While this approval covers all 27 European Union member states, the US FDA is currently reviewing a supplemental New Drug Application (sNDA) for the 7.2 mg dose, with a decision still pending.
The approval is supported by results from the Phase IIIb STEP UP trial, a randomized, double-blind, placebo-controlled study involving 1,407 adults with obesity. The trial evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to the standard 2.4 mg dose and placebo. The study met its primary endpoint, with patients in the 7.2 mg arm achieving a mean weight loss of approximately 21% over 72 weeks, compared to roughly 17.5% for the 2.4 mg dose and minimal reduction in the placebo group. Around one-third of participants on the high dose lost 25% or more of their body weight. The safety profile was consistent with the GLP-1 receptor agonist class, with gastrointestinal adverse events being the most common, though slightly more frequent at the higher dose.
Scientific & market context
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that regulates appetite and caloric intake. The rationale for the 7.2 mg dose addresses a key clinical challenge: the “weight loss plateau” observed in some patients on the standard 2.4 mg dose. By tripling the dosage, Novo Nordisk aims to push the boundaries of pharmacological weight loss, bringing efficacy closer to the 25-30% range historically reserved for metabolic surgery or multi-agonist therapies.
Novo Nordisk adds a high-efficacy option to defend against Eli Lilly’s Zepbound (tirzepatide), a dual GLP-1/GIP agonist that has demonstrated high weight-loss figures in clinical settings. The 7.2 mg semaglutide dose joins a landscape that includes rapidly advancing pipeline assets such as Novo Nordisk’s own CagriSema (semaglutide and cagrilintide) and oral amycretin, as well as Lilly’s retatrutide. While the 7.2 mg dose offers superior efficacy to the 2.4 mg version, the requirement for three simultaneous injections pending the single-pen launch may impact initial uptake compared to single-injection competitors.