FDA Approves Foundayo, Lilly’s GLP-1 Weight Loss Pill

On April 1, the U.S. Food and Drug Administration (FDA) approved Foundayo, Eli Lilly’s oral glucagon-like peptide-1 (GLP-1) pill, for chronic weight management.

Weekly injections that can spur significant weight loss currently dominate the market; however, this latest approval makes Foundayo the second GLP-1 pill cleared for weight loss, following Novo Nordisk’s oral Wegovy, which entered the market in January.

Foundayo contains the active ingredient orforglipron. Unlike oral Wegovy, which must be taken on an empty stomach with water, Foundayo can be taken at any time of day without food or drink restrictions, a feature Lilly says may improve adherence and broaden use.

Adults taking Foundayo lost an average of 27.3 pounds on the highest dose in the clinical trial.

The FDA’s decision was based on data from Lilly’s Phase III ATTAIN clinical trial program, which enrolled more than 4,500 adults. In ATTAIN-1, participants taking the highest dose of Foundayo lost 12.4% of their body weight over 72 weeks, compared with a 0.9% loss in the placebo group. Weight loss results were dose-dependent and accompanied by improvements in several cardiometabolic risk markers, including blood pressure and cholesterol. While the pill forms of GLP-1 drugs appear to be somewhat less potent, they are likely more convenient to take, which could substantially broaden the use of GLP-1s for weight loss.

Beginning April 6, Foundayo will be available through LillyDirect, the manufacturer’s direct-to-consumer platform, with broader availability at retail pharmacies and telehealth providers shortly afterward. People with commercial insurance could have monthly copayments as low as $25 with a savings program, according to the drug manufacturer. For self-pay consumers, prices are expected to range from $149 to $349 per month, depending on dosage. Additionally, eligible Medicare Part D individuals may be able to get Foundayo for $50 per month, beginning as soon as July 1.

Why It Matters

Foundayo’s approval marks another milestone in the rapidly expanding obesity drug market. Injectable GLP-1 medications such as Wegovy and Zepbound remain more potent on average, but daily pills remove the barrier of injections and are easier to distribute, store and scale globally. Health analysts expect oral GLP-1s to significantly expand the overall market by attracting patients who have been hesitant to start injectable therapies. In fact, Wall Street analysts predict that GLP-1 drugs—both injectable and oral—will generate annual sales exceeding $100 billion by 2030.

For employers and health plans, the arrival of a second oral GLP-1 option may intensify pricing competition, accelerate member demand, and further complicate coverage and utilization management strategies already under pressure from GLP-1 adoption.

Employers can stay up to date on emerging trends in the prescription drug market to remain informed and guide their benefits decisions. We’ll keep you updated with any notable developments.