Eli Lilly's weight loss drug pill just got FDA approval

The Food and Drug Administration approved Eli Lilly $LLY's new oral weight loss drug Foundayo, the company said Wednesday, making it the market's only GLP-1 pill that can be taken at any time of day without restrictions on food or water.

The drug, generically known as orforglipron, will be sold as a once-daily tablet. Lilly said it will first launch through LillyDirect before rolling out to traditional pharmacies and telehealth platforms in the weeks that follow.

For those without insurance, the monthly price varies by dosage tier, running anywhere from $149 to $349. Lilly is offering a coupon that could bring monthly out-of-pocket costs down to $25 for commercially insured patients.

In the ATTAIN-1 Phase 3 trial, participants who remained on the highest dose of Foundayo lost an average of 27.3 pounds, or 12.4% of body weight, compared with 2.2 pounds for those on placebo. The trial enrolled more than 3,100 participants across multiple countries over 72 weeks.

Unlike injectable GLP-1 therapies such as Zepbound, which require complex production methods, Foundayo belongs to a class of small molecules that are easier to manufacture and scale worldwide, Eli Lilly CEO Dave Ricks told CNBC. Ricks said the company has sought clearance from regulators in dozens of countries ahead of a wider global release.

The drug's FDA approval positions it as a direct competitor to Novo Nordisk's Wegovy pill, which exceeded 600,000 prescriptions in March, according to CNBC. The two companies matched each other on entry-level pricing, setting their lowest dose at $149 a month for uninsured patients following an agreement with the Trump administration.

Foundayo's clinical weight loss performance, at about 12.4% of body weight, trails the roughly 16.6% reduction Novo's pill achieved in its own late-stage study. By contrast, Wegovy's pill comes with strict intake instructions, requiring patients to fast and limit their water intake before taking it at the start of their day.

"We want people to be on the medicine that meets their health goals," Ricks said. "If it has Lilly on the box, that's the goal we have."

FactSet consensus figures reported by CNBC project the drug will bring in $14.79 billion annually within five years, roughly half the $24.68 billion forecast for Lilly's injectable Zepbound.

Foundayo carries warnings including a potential risk of thyroid tumors and thyroid cancer. The most common side effects include constipation, diarrhea, headache, nausea, and vomiting.