Key Takeaways:
Novo Nordisk won EU approval for the first oral GLP-1 obesity pill, expanding Wegovy's reach as competition from Eli Lilly intensifies.
The European Commission cleared once-daily oral semaglutide 25 mg for adults with a body mass index of at least 30 kg/m² or at least 27 kg/m² with one or more weight-related comorbidities, to be used alongside a reduced-calorie diet and increased physical activity, the company said. The decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in May.
The approval was supported by the OASIS clinical trial program, including the OASIS 4 study, in which participants receiving oral semaglutide achieved approximately 17% weight loss compared with 3% for those on placebo when combined with lifestyle interventions. About one-third of patients treated with the drug lost 20% or more of their body weight. The safety and tolerability profile was consistent with the established injectable version, with adverse event-related discontinuation rates of 6.9% for oral semaglutide versus 5.9% for placebo.
The EU nod marks the fifth regulatory approval for the Wegovy pill after previous authorizations in the US, the UK, the United Arab Emirates and Bahrain. Novo Nordisk also secured EU approval for the Wegovy 7.2 mg injection in a single-dose pen. The company plans to introduce the oral treatment in additional countries during the second half of 2026.
The approval comes as Novo Nordisk faces mounting pressure from Eli Lilly, whose Zepbound (tirzepatide) overtook Wegovy in weekly US prescriptions earlier this year. Novo Nordisk has guided for 2026 sales to decline between 5% and 13% as competitive dynamics shift. The oral formulation gives Novo Nordisk a differentiated product in the tablet segment, but Eli Lilly and other rivals are advancing their own oral GLP-1 candidates. Outside the US, generic manufacturers in India and China are preparing to enter the market as semaglutide patents expire, with more than 10 Indian companies including Sun Pharma and Dr Reddy's seeking clearance for Phase III trials of oral semaglutide.
For Novo Nordisk holders, the EU approval provides a near-term development in a market that is becoming increasingly contested. Investors will watch the rollout in additional EU countries through the second half of 2026 and monitor whether oral Wegovy can help stem market share losses to tirzepatide.
This article is for informational purposes only and does not constitute investment advice.
