US FDA approves first GLP-1 pill for weight loss

The United States’ Food and Drugs Administration (FDA) has approved the first GLP-1 once-a-day Wegovy pill for weight loss and reducing cardiovascular risks in adults, the manufacturer Novo Nordisk announced on Monday. This represents a major milestone in the expansion of these medications. 

The oral version enhances accessibility for patients averse to injections, with  CEO Mike Doustdar declaring, “The pill is here.” Wegovy is expected to encounter competition from Eli Lilly’s pending FDA approval for its own weight-loss pill.

As per reports, Novo Nordisk will  start selling its starting dose of its pill in early January, but there is no information when the other doses will be available until the launch.

The company had launched the injectable Wegovy in March 2022, with overwhelming demand outstripping supply, landing it on the FDA’s shortage list for over two years and enabling compounding pharmacies to produce cheaper alternatives that eroded the drugmaker’s blockbuster revenue.

Wegovy pill'’s starting dose of 1.5 mg will cost $149 per month, while prices for the three higher doses remain undisclosed.

This initial dose undercuts the injectable Wegovy’s entry-level pens, priced at $199 monthly for new cash-paying customers through March’s end, before rising to $349 or more, as per reports.

The Novo Nordisk’s headline weight-loss claims driving the pill’s approval stem from trials using the top 25 mg dose, not this entry-level option.

Trial participants on that maximum dose have shed about 14% of body weight over 64 weeks, outperforming placebo by 11% and matching injectable Wegovy’s results, though trailing Eli Lilly’s Zepbound at 20%.

Novo also offers Rybelsus, a GLP-1 pill for diabetes with the same semaglutide base but a lower 14 mg cap versus Wegovy's 25 mg max tailored for weight loss.

Eli Lilly recently sought FDA nod for its obesity pill Orforglipron, backed by a fast-track voucher like Novo Nordisk’s. Analysts predict approval and launch by mid-2026.

Orforglipron showed slightly less weight loss than Wegovy in trials (designs vary), but boasts fewer rules and no need for empty-stomach morning dosing with limited water, unlike Wegovy’s restrictions.