On April 1, the FDA approved Foundayo (orforglipron), Eli Lilly’s once-daily oral GLP-1 receptor agonist for obesity, which is the first oral GLP-1 approved for weight management and the fastest new molecular entity approval since 2002. Foundayo was cleared under the FDA’s Commissioner’s National Priority Voucher program just 50 days after filing, nearly 10 months ahead of its scheduled review date.
The approval arrives at a surreal moment for Lilly. The company just overtook every other pharmaceutical company on the planet by revenue. Its stock, meanwhile, has fallen nearly 14% since January 1.
Lilly’s rise to No. 1
Lilly posted $65.18 billion in FY2025 revenue, up 44.7% year-over-year, the largest growth rate among the top 20 pharma companies. That vaulted it past Merck ($65.01B), Pfizer ($62.58B), and AbbVie ($61.16B) into the No. 1 spot for the first time. The margin over Merck was only $170 million, but the growth gap was far wider: Lilly expanded at 44.7% while Merck managed 1.3%.
| Rank | Company | FY2025 revenue | YoY growth |
| 1 | Eli Lilly | $65.18B | 44.7% |
| 2 | Merck & Co. | $65.01B | 1.3% |
| 3 | Pfizer | $62.58B | -1.7% |
| 4 | AbbVie | $61.16B | 8.6% |
| 5 | Johnson & Johnson | $60.40B | 5.8% |
The engine behind that surge? Largely traditional injectable GLP-1s. Mounjaro generated $9.0 billion in H1 2025 alone, up 90% year-over-year. Zepbound, the obesity-indication version of tirzepatide, added $5.7 billion in H1 2025, a product that was not launched until late 2023 and is now available in a multi-dose KwikPen. Together, GLP-1s are on pace to exceed $30 billion annualized.
Why Foundayo matters
Until recently, every current GLP-1 blockbuster apart from Rybelsus, including Ozempic, Wegovy, Mounjaro, Zepbound, was injectable. Novo Nordisk’s oral Wegovy, approved in December 2025, was the first oral GLP-1 to hit the obesity market. But it is a peptide formulation that must be taken on an empty stomach with restricted water intake. Foundayo is a small molecule that can be taken at any time of day without food or water restrictions.
Lilly CEO Dave Ricks recently noted that Foundayo is “not more effective” than the company’s injectable Zepbound, he told CNBC, “but it’s more accessible, it’s easier to fit into your daily routine.” In ATTAIN-1 trials, patients on the highest dose lost an average of 12.4% of their body weight over 72 weeks, compared to the 20%-plus weight loss typically seen with injectable tirzepatide. But Ricks framed the drug as complementary, not competitive: “We want people to be on the medicine that meets their health goals. If it has Lilly on the box, that’s the goal we have.”
The GLP-1 market has expanded from under $12 billion in 2022 to a roughly $65 billion annualized run rate by mid-2025. An oral option for obesity could expand the addressable population. Lilly has submitted orforglipron for approval in more than 40 countries.
Lilly originally licensed orforglipron from Japanese drugmaker Chugai in 2018 for $50 million upfront.