The United States Food and Drug Administration has given approval to a pill version of the weight-loss medication Wegovy, its manufacturer Novo Nordisk has announced, marking a major milestone in obesity treatment.
The approval makes Wegovy the first weight-loss drug of its kind to be cleared by the FDA in pill form, signalling a significant shift away from injectable-only treatments.
Novo Nordisk, the Danish pharmaceutical company behind Wegovy, described the once-daily tablet as a more user-friendly alternative to injections, saying it delivers the same level of weight loss as the shot. Wegovy had previously received FDA approval specifically for weight management.
Other drugs with similar effects, such as Ozempic, were initially authorised for treating Type 2 diabetes, even though they later became popular for weight loss.
According to Novo Nordisk, clinical trials showed the Wegovy pill led to an average weight reduction of 16.6%. The company said in a statement released on Monday that about one-third of the roughly 1,300 trial participants lost at least 20% of their body weight.
The company plans to roll out the pill in the United States in early January 2026.
“Patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, the firm’s chief executive.
The pill’s approval could help revive Novo Nordisk’s sales after a difficult year in which the company warned about profits and saw its share price decline.
The firm has been under growing pressure from competitors in the booming weight-loss drug market, particularly US rival Eli Lilly.
Following the announcement, Novo Nordisk’s shares jumped nearly 10% in after-hours trading in New York.
