Novo Nordisk Secures EU Regulatory Boost for Oral Wegovy as Eli Lilly Raises the Obesity Bar

EU recommends Novo's oral semaglutide for weight loss, but Eli Lilly's Retatrutide achieves 28.3% weight reduction in Phase 3, intensifying the $100B obesity drug race.

The battle for dominance in the weight-loss drug market intensified this week after Novo Nordisk won a crucial European endorsement for its oral semaglutide formulation, even as rival Eli Lilly unveiled Phase 3 data that set a new efficacy benchmark. The Danish drugmaker announced on 22 May 2026 that the European Medicines Agency’s human medicines committee had recommended approval of a 25 mg Wegovy tablet for weight management, positioning it as the first oral GLP-1 receptor agonist to receive a positive CHMP opinion in the EU.

The recommendation marks a strategic milestone for Novo, which has been racing to expand beyond injectable therapies. Oral administration offers a simpler daily routine for patients, a factor the company hopes will unlock a broader segment of the obesity market. In the OASIS 4 clinical trial, patients who adhered to the oral regimen achieved an average weight reduction of 16.6%, with roughly one-third shedding at least 20% of their body weight. The application also incorporates data from the SELECT study, which demonstrated that Wegovy lowers the risk of major adverse cardiovascular events.

Yet the regulatory tailwind arrives as Eli Lilly raises the competitive stakes. The US drugmaker reported that its triple-agonist Retatrutide delivered an average weight loss of 28.3% — approximately 32 kilograms — in a Phase 3 study of 2,500 participants. The placebo group lost just 2.2%. Nearly 45% of patients on Retatrutide lost 30% or more of their body weight. Retatrutide targets three receptors — GLP-1, GIP and glucagon — whereas Novo’s semaglutide acts only on GLP-1. A US approval is not expected before 2027, but the data have sharpened the focus on Novo’s ability to defend its market position in a sector analysts estimate could be worth $100 billion.

Novo’s oral Wegovy has been available in the US since January 2026, and CEO Mike Doustdar described the early trajectory as a “turnaround situation.” Weekly prescriptions for the pill exceeded 200,000 in the week ending 17 April, and cumulative prescriptions since launch have topped 2 million. First-quarter 2026 injectable Wegovy sales rose 12% to 18.2 billion Danish kroner, just shy of consensus estimates, while US new-prescription market share held at 65%. In April, Eli Lilly launched its own oral obesity drug Foundayo in the US, ending Novo’s brief monopoly in the oral segment there.

On the Copenhagen exchange, Novo Nordisk’s Class B shares closed at 38.74 euros on Friday, up 1.25% on the day. The stock has rallied 16.20% over the past 30 days but remains 35.79% lower year-on-year and trades 8.17% below its 200-day moving average. The relative strength index stands at 47.3, indicating neither overbought nor oversold conditions. Analysts tracked by S&P Global maintain a consensus “Buy” rating based on 14 recommendations, with an average price target of $46.72 and a high of $64.19.

Management is also signalling confidence through a share buyback programme of up to 15 billion kroner. By 13 May, Novo had repurchased B-shares worth roughly 4.17 billion kroner at an average price of around 35 euros per share. The repurchases have so far failed to provide lasting support for the stock price, but they underscore the company’s view that the equity is undervalued.

Beyond obesity, Novo is working to broaden the therapeutic reach of semaglutide. The ESSENCE programme has already shown that a 2.4 mg dose can significantly reduce liver inflammation and fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH), a condition affecting an estimated 250 million people globally. New subgroup analyses are examining liver safety, postmenopausal women and Japanese patients — populations often underrepresented in liver research. Confirming benefit in these groups would strengthen the drug’s claim to address a disease where nine out of ten cases remain undiagnosed.

Operationally, Novo delivered a first-quarter surprise. Adjusted operating profit came in at 32.86 billion kroner, well above the market consensus of 28.74 billion kroner. The company narrowed its full-year guidance to a 4% to 12% decline in both revenue and operating profit at constant exchange rates, reinforcing the view that 2026 will be a transitional year. The next major catalysts include the formal European Commission decision on the oral Wegovy tablet — which typically follows a positive CHMP opinion — and a rollout in selected markets outside the US in the second half of the year. Novo also continues to advance pipeline candidates such as combinations with Cagrilintid, now in clinical trials. The half-year results due on 5 August 2026 will provide the clearest indication yet whether the company can turn its pipeline promise into market momentum.