FDA Approves Eli Lilly's Obesity Pill
People turning to GLP-1 medications for weight loss now have another option. On April 1, the U.S. Food and Drug Administration (FDA) approved Foundayo (orforglipron), a new daily pill to treat obesity made by Eli Lilly. The drug is approved for people who are overweight or obese and have at least one weight-related health issue, such as high blood pressure or heart or kidney issues.
Wegovy pill, from Novo Nordisk, was the first oral GLP-1 drug to be approved by the FDA, in December 2025. Foundayo is the second. The first versions of GLP-1s were injectable drugs that people had to give themselves weekly.
The FDA approved Foundayo based on two trials conducted by Lilly in those who were overweight or obese. They showed that people taking the drug lost on average 11% of their body weight, or 25 pounds, over more than a year compared to people taking placebo, who lost on average of 5.3 pounds. By comparison, Wegovy pill, which the FDA approved in December 2025, helps people lose 16% to 17% of their starting body weight compared to those taking placebo. The two pills target different GLP-1 hormones involved in weight.
How Foundayo works
As with the injectable forms of GLP-1s, Foundayo is available in six doses, ranging from 0.8mg to 17.2mg. In consultation with their doctors, patients start with the lowest dose and gradually work up to higher doses; not everyone may need to reach the highest dose.
Foundayo targets a different GLP-1 from the ones in Lilly’s injectable forms (Mounjaro and Zepbound), says Dr. Dan Skovronsky, the company's chief scientific and product officer. Lilly licensed orforglipron from a Japanese pharmaceutical company in 2018. At the time, Lilly was focused on advancing tirzepatide, which became Mounjaro for diabetes and Zepbound for weight loss, but continued to develop orforglipron as a pill.
People taking orforglipron do not need to restrict food or drink after taking the pill, says Skovronsky. (Wegovy pill is a peptide, and people taking the drug need to avoid eating or drinking for 30 minutes after taking the pill.) Orforglipron is a small molecule that the body can absorb quickly and get into the blood, where it reaches the necessary tissues, Skovronsky explains.
He says the side effects seen with Foundayo are similar to those observed with injectable GLP-1 medications—including nausea, constipation, vomiting, diarrhea, and indigestion, as well as the rarer increased risk of thyroid cancer.
The promise of a pill
“We see Foundayo as a foundational GLP-1 therapy,” said Eli Lilly CEO David Ricks during a press briefing, explaining the name of the drug. Lilly’s studies show that Foundayo could be an effective maintenance therapy for people looking to sustain weight loss after using the injectable GLP-1s to reach a target weight, and Ricks said the company has “broad ambitions” for seeking additional indications for the drug, including sleep apnea, hypertension, and stress urinary incontinence, for which it plans to submit to the FDA in coming months and years.
A daily pill could make GLP-1 drugs more accessible to people. Studies show that about half of people currently using them in the injectable form stop taking them either temporarily or permanently. For some, the high cost is a barrier; for others, it's the stigma and hassle of injections. Because it’s cheaper to manufacture pills compared to injectable medications, both Lilly and Novo Nordisk have agreed with the White House to roll out the initial doses of their pills at $149 a month for people who are uninsured and for Medicare beneficiaries who have diabetes. Later this summer, more Medicare beneficiaries will become eligible for coverage under a new program, including those with other obesity-related health conditions such as hypertension or kidney or heart disease, and their cost would be $50 a month. Prices increase with increasing doses, and Ricks said those costs would be capped at $299 a month if people participate in the company’s Self-Pay Journey program, and renew their prescriptions within 45 days of the previous one. If people don’t participate in the program, the cost would be $349 a month for the highest dose.
For people covered by insurance, Ricks said the drug would cost no more than $25 for every prescription as long as people download a savings card from the company’s website.
Foundayo is the first drug approved under the FDA’s new Commissioner’s National Priority Voucher program, which expedites review of new medications. It only took 100 days from when Lilly submitted its request until its approval, and Ricks said the review was “thorough and deep with no differences other than time scale.” Under the traditional review system, the FDA would have had until January 2027 to make a decision.
The quick action means Foundayo will be available next week on Lilly Direct and in pharmacies. “Obesity is a massively scaled problem and affects 100 million people in the U.S. and up to 1 billion around the world,” says Skovronsky. “This is a population health problem and it needs a population health solution. We want to impact human health, and we have the opportunity to do that with this pill.”