For the first time, regulators have approved a small-molecule pill targeting glucagon-like peptide1 (GLP-1) for weight loss. The once-daily oral medicine, developed by Eli Lilly and Company, will be an option for people who may not want to take the popular range of GLP-1 injections.
The pill contains the active ingredient orforglipron and will be sold under the brand name Foundayo. It will be shipped to patients with prescriptions starting April 6, the company says in a press statement.
Chemical structure of orforglipron.
Foundayo’s most direct competitor will be an oral version of Novo Nordisk’s Wegovy that the US Food and Drug Administration approved in December. Its active ingredient is the peptide semaglutide, the same molecule used in Novo Nordisk’s injectable weight-loss drug.
Foundayo can be taken at any time of day without food or water restrictions, Lilly says. In contrast, the Wegovy pill needs to be taken on an empty stomach immediately upon waking, with no more than about 118 mL of water, and the patient must wait half an hour before eating, drinking, or taking other medication.
“We think on-time approval and no food effect restrictions make orforglipron slightly more favorable vs oral [Wegovy] pill, which does have a food effect, but again net-net both are similar and can help expand and split the market,” UBS Bank analysts wrote to clients on April 1.
The FDA’s approval of Lilly’s molecule is based on the company’s Phase 3 clinical trials, which showed that participants lost an average of 12.0% of their body weight after 72 weeks on the highest dose, compared with just 0.9% for those on a placebo.
The agency approved the Wegovy pill after Novo Nordisk submitted Phase 3 clinical data showing that the highest dose elicited an average weight loss of 16.0%. Still, the weight loss from the highest doses of both Lilly and Novo Nordisk’s injectables is greater than that from their respective pill forms.
Lilly is the first across the finish line in a multicompany race to develop small-molecule GLP-1 weight-loss pills. Though peptide-based drugs are a natural choice for treating hormonal conditions, experts say small molecules offer several advantages, including easy absorption by gut cells, since they are vastly smaller than peptides. Other benefits include ease of manufacturing and thus lower cost than peptides.
Foundayo was approved under the controversial Commissioner’s National Priority Voucher pilot program, which shortens the review time for selected molecules from the standard 10–12 month period to 1–2 months. The approval was the fastest for a new molecular entity since 2002, the FDA says.
Lilly says the cost of the new pill could be as low as $25 per month for people with commercial insurance. For those who self-pay, prices could start at $149 per month.
This year, Lilly became the first pharmaceutical company to reach a $1 trillion stock market value, largely fueled by sales of Zepbound and Mounjaro, its peptide weight-loss and antidiabetes injectables. In anticipation of orforglipron’s approval, the company announced several manufacturing investments and had stockpiled close to $1.5 billion worth of the active ingredient as of the end of 2025, according to Lilly’s latest regulatory filings.
Lilly is already working on a new range of weight-loss drugs that target receptors other than GLP-1. They include eloralintide, a peptide that mimics a hormone called amylin, and retatrutide, a once-weekly injectable that targets three receptors at once: glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon.
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