The Food and Drug Administration approved Eli Lilly’s new oral obesity drug, Foundayo, on April 1. The company said prescriptions for the pill are now being accepted through LillyDirect, with shipping to begin on April 6. Foundayo will be available at $25 per month for those with commercial coverage and $149 per month for self-pay customers.
Foundayo is the fifth medication to receive approval under the FDA’s Commissioner’s National Priority Voucher Program, which was introduced in June 2025 to speed up review times for drugs that meet certain national priorities. According to the FDA, Foundayo was approved just 50 days after filing—294 days before its official target date of January 20, 2027.
The launch of Foundayo is expected to strengthen Lilly’s position in the weight loss and diabetes market alongside its other products Mounjaro and Zepbound. Truist Securities estimated in November that these three drugs could generate $101 billion in peak worldwide revenue if all eligible patients are treated at an average price of $200 per month.
Pricing discussions between pharmaceutical companies and government officials have also played a role in shaping market competition. In November, a deal between Lilly, Novo Nordisk, and the White House set initial doses of both Foundayo and Novo's oral Wegovy at $150 each. Oral Wegovy entered the U.S. market earlier this year but faces new competition from Foundayo as clinical data suggest it may offer greater weight loss benefits.
Clinical trials supported Foundayo's approval: In Phase 3 studies, patients taking the highest dose lost an average of over 27 pounds after more than a year of treatment. The drug also improved key cardiometabolic risk factors according to company press releases. However, there have been no direct head-to-head trials comparing it with Novo Nordisk's oral Wegovy so far.
The FDA noted that Foundayo carries a boxed warning about thyroid C-cell tumors and should not be used by individuals with certain medical histories involving thyroid cancer or endocrine syndromes.
As both companies compete for dominance in this growing sector—Lilly reported nearly $23 billion in sales last year from Mounjaro alone—the introduction of another major product like Foundayo signals ongoing changes ahead for obesity treatment options.
