Novo's Wegovy pill cleared for weight loss in EU
Novo Nordisk
The European Commission has approved Novo Nordisk's pill formulation of weight-loss therapy Wegovy, making it the first oral GLP-1 agonist for obesity and overweight in the EU.
The green light, which follows an approval recommendation from the EMA's human medicines committee in May, keeps the Danish drugmaker on course to meet its plan of launching Wegovy (semaglutide) in several markets outside the US – where it was launched in January – in the latter half of this year.
The new product has already been introduced in the UK, its first European market, and is also available in the UAE and approved in Bahrain.
EU approval also helps Novo Nordisk to maintain its lead in the oral obesity therapy category over Eli Lilly, which is in hot pursuit with its oral GLP-1 drug Foundayo (orforglipron). Regulatory reviews of Foundayo are still ongoing in EU countries, and Lilly has said it does not expect to launch its drug there until 2027.
The once-daily, oral 25 mg pill has been cleared for the treatment of adults with a BMI of 30 or more, putting them into the category for obesity, as well as individuals considered overweight with a BMI of 27 or over.
Novo Nordisk maintains that the Wegovy pill provides best-in-class efficacy in the oral category, achieving 17% average weight loss compared with 3% with placebo when used alongside lifestyle interventions like diet and exercise.
The company has reported that the Wegovy pill launch is the strongest of any GLP-1-based weight-loss product to date, bringing in sales of $355 million in the first quarter of 2026.
And in a second piece of good news for Novo Nordisk, which is fighting to stay in contention with Lilly in the fast-growing GLP-1 category overall, the Commission also approved a new high-strength version of Wegovy injection in a single-dose pen.
The high-dose version is already marketed in the EU in a vial formulation under the Wegovy HD brand name, and is another important line extension for Novo Nordisk as it tries to protect its weight-loss franchise from Lilly's injectable GIP/GLP-1 agonist Zepbound/Mounjaro (tirzepatide), which has been growing at a phenomenal pace after besting Wegovy in a head-to-head trial.
Boehringer takes obesity triple into phase 2
In other weight-loss news this week, Boehringer has started a phase 2 trial of a new triple agonist, BI 3034701, which stimulates GLP-1, GIP, and NPY2, a new target the company believes plays a role in controlling hunger, appetite, and food intake.
That ties in with a trend among obesity drug developers to bundle multiple activities in a single molecule. Other triple agonists in development include Lilly's highly anticipated retatrutide – targeting GLP-1, GIP and glucagon and being prepared for regulatory filings later this year – and Novo Nordisk's similarly acting UBT251 in phase 2.
