Quick Facts

• FDA approved Eli Lilly’s Foundayo obesity pill in 50 days, the fastest approval for a new drug class since 2002
• Clinical trials show patients lost average of 25 pounds (11% body weight) on highest dose over 16 months
• Unlike competing pills, Foundayo can be taken anytime without food or water restrictions

The FDA approved Eli Lilly’s obesity pill Foundayo on April 1, marking the fastest approval for a new drug class in over two decades. The agency fast-tracked the medication under its new Commissioner’s National Priority Voucher program in just 50 days.

Foundayo targets adults with obesity through a once-daily pill containing orforglipron, a GLP-1 receptor agonist. The drug offers a more convenient alternative to existing obesity treatments that require injections or strict dosing schedules.

Clinical Results Show Significant Weight Loss

In the ATTAIN-1 clinical trial involving more than 3,000 adults with obesity, participants taking the highest 36-milligram dose lost an average of 25 pounds over 16 months. This represents 11.2% of their total body weight compared to 2.1% weight loss in the placebo group.

Patients who stayed on treatment throughout the study achieved even better results, losing an average of 27.3 pounds (12.4% of body weight) versus 2.2 pounds (0.9%) with placebo.

The results position Foundayo between injectable options and other oral alternatives. Eli Lilly’s injectable Zepbound achieves 21% average weight loss, while Novo Nordisk’s injectable Wegovy averages 15%. Among oral options, Novo’s Wegovy pill shows 14% weight loss compared to Foundayo’s 11%.

Pricing and Market Access

Foundayo will cost between $149 and $349 monthly for cash-paying patients, depending on dose. Insured patients may pay as little as $25 monthly with Eli Lilly’s coupon program. Medicare patients will have access starting July with potential $50 monthly copays.

The drug ships Monday through Eli Lilly’s direct-to-consumer platform LillyDirect, with pharmacy and telehealth availability following shortly after.

Analysts project Foundayo sales will reach $14.79 billion by 2030, according to FactSet. This compares to expected sales of $24.68 billion for Zepbound and $44.87 billion for Eli Lilly’s diabetes drug Mounjaro.

Convenience Factor Sets Foundayo Apart

Unlike Novo Nordisk’s oral Wegovy pill, which requires taking with water on an empty stomach followed by a 30-minute wait before eating, Foundayo has no food or water restrictions. Patients can take it any time of day.

“We’ve created a small molecule chemical which gets in your body very well. It can mimic the effects of the peptide and can be taken more conveniently any time of day,” said Daniel Skovronsky, Eli Lilly’s chief scientific and product officer.

Dr. Catherine Varney, obesity medicine director at UVA Health, expects the convenience factor may help patients achieve better results. “This pill is easier to take, especially for people with complex medical regimens or people who struggle with strict dosing,” she said.

The approval intensifies competition between Eli Lilly and Novo Nordisk in the rapidly growing obesity treatment market. Foundayo launches just three months after Novo’s oral Wegovy pill, setting up direct competition in the oral GLP-1 space.

Read more: The FDA approves a new obesity pill, giving patients another option