2 oral GLP-1s are now available: What matters most for real-world prescribing
Industry Buzz
The jury is still out in terms of what people are really going to achieve with these pills. I mean, 12% is weak compared to what you're going to see with Wegovy and Zepbound.
—Jody Dushay, MD, via NBC News
Given it is in a pill and not an injection, which reduces supply chain needs around plastics and cold storage, and that it does not have special instructions to take it, it is likely to become a popular choice for primary care [physicians] as they won't have to demonstrate pen usage.
—Deborah Horn, DO, to Vox
The US Food and Drug Administration has approved Foundayo (orforglipron), Eli Lilly’s GLP-1 receptor agonist pill, the company announced on April 1.[]
Foundayo stands out among popular GLP-1 options, as it can be taken at any time of day without food or water restrictions.
With two major oral GLP-1 contenders now on the market, the inevitable question follows: How do they stack up?
Fast-tracked approval
Lilly plans to offer the pill through its drug purchasing platform LillyDirect, and is accepting prescriptions immediately, with shipping scheduled to begin on April 6, and is expected to hit pharmacy shelves shortly after.[]
“People living with obesity need treatment options that meet them where they are… and for many, a once-daily pull that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,” Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, said in Lilly’s press release.[]
Foundayo’s approved indications:
In combination with a reduced-calorie diet and physical activity to reduce excess body weight
For maintaining weight loss long-term in adults with obesity; or overweight adults with at least one weight-related comorbidity.[]
The FDA’s decision is the first new molecular entity (NME) approved under the FDA Commissioner’s National Priority Voucher (CNPV) pilot program. The program grants speedy reviews for drugs that are considered national priorities. It is the fastest approval of an NME since 2002, according to the FDA.[]
The program, which launched in 2025, has awarded 18 vouchers and issued six decisions so far. The FDA’s target timeline for decisions under the program is 2 months.[]
This particular decision comes just a few months after Lilly submitted the drug to the FDA for approval. This puts Foundayo just 3 months after rival drugmaker Novo Nordisk’s Wegovy pill, which launched in early January 2026.[]
The FDA based its approval on data from Lily’s ATTAIN clinical trial. In the study, patients on the highest dose of Foundayo who took the treatment as intended lost an average of 27.3 pounds, or 12.4% of their average body weight, compared to 2.2 pounds for those who received placebo.[]
Related: 5-year GLP-1 data raises red flags for bone and joint health. What now?Which GLP-1 pill is best?
With two major oral GLP-1 contenders now on the market, the inevitable question follows: How do they stack up? There are a few key differences.
For one, Foundayo comes with no food or water restrictions, which could widen the pool of potential patients. The Wegovy pill, on the other hand, must be taken first thing in the morning, 30 minutes before food or drink, which can interfere with its absorption.[]
There has not been a head-to-head trial comparing the efficacy of orforglipron and semaglutide, but the Wegovy pill has demonstrated more significant weight loss than any other oral GLP-1 obesity drug in a Phase 3 study. The pill gained its FDA approval based on data showing an average 16.6% weight loss among patients who took it as intended.[]
"The jury is still out in terms of what people are really going to achieve with these pills. I mean, 12% is weak compared to what you're going to see with Wegovy and Zepbound," Jody Dushay, MD, an endocrinologist and obesity expert at Harvard Medical School, told NBC News.[]
"Not all GLP-1s are the same," Jamey Millar, Novo's EVP of US operations, told Fierce Pharma.[] Millar added that Wegovy is the only GLP-1 with "proven" claims that it reduces the risk of major adverse cardiovascular events, including death, heart attack, or stroke.[]
Regardless, more options for once-daily pills could capture a broader cohort of patients who have been reluctant to use injectable GLP-1s for weight loss, as oral treatments remove a common barrier to entry.
"Given it is in a pill and not an injection, which reduces supply chain needs around plastics and cold storage, and that it does not have special instructions to take it, it is likely to become a popular choice for primary care [physicians] as they won't have to demonstrate pen usage," Dr. Horn told Vox.[]
Related: Play Now: GLP-1s, Hype vs Hard Evidence