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FDA Approves First GLP-1 Weight Loss Pill

Novo Nordisk’s Wegovy pill, the first weight-loss drug to win approval from the agency, is expected to launch in the US in early 2026.
Research showed that taking Novo's new anti-obesity pill can result in almost as much weight loss as its Wegovy jab.
Research showed that taking Novo's new anti-obesity pill can result in almost as much weight loss as its Wegovy jab. (Shutterstock)

The US Food and Drug Administration approved Novo Nordisk’s weight-loss pill on Monday, giving the Danish drugmaker a leg up in the race to market a potent oral medication for shedding pounds as it looks to regain lost ground from rival Eli Lilly.

The pill is 25 milligrams of semaglutide, the same active ingredient in injectable Wegovy and Ozempic, and will be sold under the brand name Wegovy. Novo already sells an oral semaglutide for type 2 diabetes, Rybelsus.

The approval could help spur a turnaround for Novo after a rocky year of sliding shares, profit warnings and slowing sales of its injectable Wegovy amid intense competition from Lilly and pressure from compounded versions.

A 64-week, late-stage study showed participants who took 25 mg of oral semaglutide once daily lost an average of 16.6 percent of their body weight, compared with 2.7 percent for those on a placebo.

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The pill was approved for chronic weight management in adults with obesity or overweight and at least one related health condition, broadening the potential patient pool at a time when insurers, employers and governments are wrestling with spiralling healthcare costs related to obesity.

It could help open the door to tens of millions of untapped patients in a global market, forecast to be worth some $150 billion a year by next decade.

By Maggie Fick

Learn more:

The GLP-1 Arms Race, Explained

The pharmaceutical boom in weight-loss drugs has put companies like Novo Nordisk and Eli Lilly in ever-fiercer competition. Now more heavyweights, like Pfizer and Astrazeneca, are entering the ring. Who will come out on top?

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