Lilly's Foundayo pill cuts sleep apnea severity by up to 44% in late-stage trial, with an FDA filing planned by year-end
Eli Lilly (LLY) said on Monday that its daily obesity pill Foundayo eased obstructive sleep apnea in a late-stage trial.
The company plans to ask the Food and Drug Administration by the end of 2026 to approve the pill for adults with moderate-to-severe sleep apnea who have obesity or are overweight. Lilly's injection Zepbound became the first drug approved for the condition in December 2024.
In sleep apnea, the airway keeps collapsing during sleep. Oxygen levels drop and blood pressure rises, which is linked to heart failure and stroke. Lilly puts the number of adults with the condition at 936 million worldwide, most of them undiagnosed.
The Phase 3 program ran two year-long studies against a placebo. One enrolled 363 people who could not or would not use a breathing machine, known as PAP therapy. The other enrolled 349 people who kept using one.
| After one year | No breathing machine | With breathing machine |
|---|---|---|
| Fewer breathing interruptions, Foundayo | 43.8% | 27.5% |
| Fewer breathing interruptions, placebo | 6.3% | 3% |
| Remission or mild disease, Foundayo | 31.5% | 19.6% |
| Weight loss, Foundayo | 11.5% | 11.2% |
The trial measured how often breathing stops or turns shallow each hour of sleep. Foundayo cut that count by roughly seven times as much as the placebo in the group without a machine.
The side effects were mostly mild to moderate stomach problems such as nausea and diarrhea. In the group without a machine, 12.2% of patients on Foundayo stopped taking it because of side effects, against 3.8% on placebo.
Thomas Seck, who leads product development for Lilly's cardiometabolic drugs, called sleep apnea "one of the most serious complications of obesity." He added that Foundayo "is already making a difference for people living with obesity."
The pill went on sale in the U.S. in April. It brought in $184M in the third quarter, a small part of Lilly's $24.4B in total revenue.
Lilly shares were up 1.8% at 9:46 a.m. ET, a little ahead of the S&P 500's 1.5% gain.
The results were presented at the American Heart Association's annual meeting and published in the medical journal JAMA.
Sources & Further Reading
- "Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss." Eli Lilly and Company. November 9, 2026.
- "Eli Lilly's Foundayo obesity pill eases sleep apnea in late-stage trial, paving way for approval." CNBC. November 9, 2026.
- "Eli Lilly Q3 2026 Earnings Release." Eli Lilly and Company. October 29, 2026.
- "Orforglipron for Obstructive Sleep Apnea: Results From 2 Randomized Clinical Trials." JAMA. November 9, 2026.
This article was drafted with the help of AI. Kris Gunnars fact-checked, edited and published the article and is responsible for its accuracy and quality. How we use AI
