The U.S. Food and Drug Administration granted approval on Wednesday to Eli Lilly’s weight-loss medication, Foundayo, marking a significant step in the competition against Novo Nordisk for the growing market of GLP-1-based obesity treatments. Foundayo, scientifically known as orforglipron, is a once-daily oral pill that targets the GLP-1 hormone, helping patients lose between 12% and 15% of their body weight in clinical trials.
Lilly announced that Foundayo will be available starting April 6 through its LillyDirect program at a price of $149 per month for the lowest dose for self-paying customers, matching the cost of Novo Nordisk’s oral pill. Shortly after, the drug will be accessible via retail pharmacies and telehealth providers. David Ricks, Lilly’s CEO, described the medication as a practical, once-daily oral option that delivers substantial weight loss, designed to meet real-world obesity care needs.
In a notable development, the FDA fast-tracked Foundayo’s approval under its new voucher program, positioning Lilly directly against Danish pharmaceutical giant Novo Nordisk. Novo was the pioneer in GLP-1 treatments with its injectable drugs Ozempic for diabetes and Wegovy for obesity, and it currently leads the U.S. market for these medications. Novo also secured the first-to-market advantage for oral GLP-1 drugs by launching oral Wegovy in January, which has seen strong demand.
Foundayo offers greater convenience compared to oral Wegovy, as it can be taken at any time of day without restrictions, whereas Wegovy must be taken first thing in the morning on an empty stomach, 30 minutes before food, water, or other medications. BMO analyst Evan Seigerman noted that investors will closely watch whether Foundayo’s lack of food-related restrictions influences patient adoption during the early stages of its launch. Following the approval announcement, Lilly’s shares rose by 6%, while Novo’s U.S.-listed shares experienced a slight decline.
Regarding the market dynamics between pills and injectables, Novo Nordisk’s U.S. operations executive Jamey Millar highlighted that most oral Wegovy users are new to GLP-1 treatments, indicating that oral pills may attract patients who have not previously used injectables. Millar emphasized that affordability and side effects tend to be more decisive factors for patients when selecting a medication. Although oral weight-loss drugs are not expected to replace injectables entirely—since injectables generally produce greater weight loss—analysts project that pills could capture about 20% of the market by 2030.
In clinical trials, orforglipron demonstrated significant efficacy. A 72-week late-stage study showed an average weight loss of approximately 12%, with most patients reaching a plateau. An earlier 36-week mid-stage trial revealed nearly 15% weight reduction. The most common side effects reported were mild to moderate gastrointestinal symptoms, including nausea and vomiting.
Foundayo carries a boxed warning—the FDA’s most serious label caution—alerting users to an increased risk of thyroid C-cell tumors, a warning also present on both oral and injectable versions of Novo’s Wegovy. The drug’s approval was expedited through the Commissioner’s National Priority voucher program, which accelerates FDA decisions for drugs deemed critical to public health or national security.
Lilly obtained this voucher as part of an agreement with the Trump administration to reduce prices of its weight-loss medications for government programs and patients paying out of pocket. FDA Commissioner Marty Makary assured that the review process for Foundayo was as comprehensive as the traditional, lengthier evaluations. He explained that the agency coordinated among various review teams to ensure thorough assessment of the application.
