The FDA approves the first GLP-1 weight loss pill

The FDA has approved the pill version of Novo Nordisk's blockbuster injectable weight loss drug Wegovy on Monday, making it the first oral GLP-1 therapy cleared to treat obesity in the United States.

The regulatory decision allows the Wegovy pill to be used in adults to support long-term weight loss and weight maintenance, as well as to reduce the risk of major adverse cardiovascular events.

An FDA-approved weight loss pill provides greater flexibility and expands patient choice by offering a GLP-1 option that is easier to take than injectables.

"The pill is here," Mike Doustdar, president and CEO of Novo Nordisk said in a press release. "With [the] approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection."

Wegovy pills are expected to hit the U.S. market within weeks, the company said.

As part of the "Most Favored Nation" deal made with Trump and his administration, the starting dose (1.5 mg) will be available in pharmacies and through select telehealth providers, including TrumpRx, for a monthly price of $149.

However, Novo has not yet specified the direct-to-consumer pricing of higher maintenance doses.

The approval also puts Novo Nordisk slightly ahead of its top competitor, Eli Lilly, which filed for FDA approval for its own obesity pill less than a week ago.

As the two rival titans fight for dominance in the booming GLP-1 space, oral therapies have become their next battleground. By 2030, oral options alone are expected to capture roughly 20% of the $80 billion obesity GLP-1 market.

Under the National Priority program, both Novo and Lilly were awarded a fast-track voucher for their GLP-1 pills last month. The vouchers speed up the FDA review timeline, shortening the process from 10-12 months to just 1-2 months.

Based on clinical data, Novo's pill appears to deliver slightly better weight loss results than Lilly's obesity pill, orforglipron, but has dosing restrictions.

Because Lilly's pill is not a peptide, it can be more easily absorbed by the body and can be taken without food or water. This gives it a convenience advantage over Novo's Wegovy pill, which must be taken on an empty stomach with a sip of water, followed by a 30-minute waiting period before eating or drinking.

"As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey," Doustdar concluded. "No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill."

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.