Eli Lilly’s Orforglipron passed the FDA green light on Wednesday, ending Novo Nordisk’s Wigovy tablet’s short reign as the only oral GLP-1 approved to treat obesity.
Now named Foundayo, the FDA has approved Lilly’s GLP-1 receptor agonist tablets as the first novel molecular entity approved under the regulator’s controversial National Priority Voucher (CNPV) program, according to an April 1 FDA announcement.
Lilly plans to offer the pill through LillyDirect, a cash-pay consumer drug purchasing platform, with an agreement to provide Foundayo to obese adults and adults who are overweight with weight-related medical problems in conjunction with a reduced-calorie diet and increased physical activity, with prescriptions being accepted immediately and shipments expected to begin April 6, according to a company press release.
Lilly said it expects the drug to be widely available through retail pharmacies and telemedicine providers in the U.S. “shortly after” LillyDirect’s launch.
Both Lilly and Novo have made strides in recent years to improve the affordability of incretin drugs for diabetes and weight loss, and that strategy is fully reflected in Lilly’s Foundayo pricing strategy.
For patients with commercial insurance, patients can use their savings cards to pay for the pills for as little as $25 a month, Lilly said, and those who choose to pay out-of-pocket can get the lowest dose of Foundayo for $149 a month. The advertised price for Foundayo is in line with Novo’s Wegovy tablets, which went on sale on January 5th.
“Currently, fewer than 1 in 10 people who could benefit from GLP-1 are not taking GLP-1 due to access, stigma, perceived complexity, or a belief that their condition is not serious enough to require treatment,” Lilly CEO David Rix said in a statement. “We believe that Foundayo will help level the playing field for people living with obesity, or those who are overweight and live with weight-related complications.”
The FDA based its approval on data from Lilly’s ATTAIN clinical program. In the ATTAIN-1 study, patients who received the highest dose of Foundayo and treated as intended lost an average of 27.3 pounds (12.4% of their mean body weight) compared to 2.2 pounds (0.9%) in weight for patients who received a placebo, Lilly said in the approval announcement.
Despite inherent flaws in comparisons between trials, Novo’s Wigovy tablets received the green light in the United States based on data showing an average weight loss of 16.6% in patients who adhered to treatment.
In Lilly’s program, regardless of trial completion, patients who took Foundayo lost an average of 25 pounds (11.1%) of their body weight, compared with 5.3 pounds (2.1%) for patients in the control group. Lilly’s clinical program also notes that Foundayo may reduce markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure “across all doses,” the company said.
Novo itself addressed the inevitable comparisons Wednesday between Foundayo and its Wegovy pill.
“Not all GLP-1s are the same. Any report claiming that orforglipron is more effective than Wegovy tablets in weight management is inaccurate and misleading,” Jamie Miller, Novo’s vice president of U.S. operations, said in an emailed statement. “No studies have directly compared the efficacy of orforglipron and Wegovy pills, and Wegovy pills demonstrated in a Phase 3 trial, alone as a single molecule, without the benefit of other drugs, that no other oral GLP-1 obesity drug candidate has demonstrated.”
Miller added that among the approved obesity drugs, Wegoby is currently the only one that can boast a “proven” claim that it also reduces the risk of serious adverse cardiovascular events such as death, heart and stroke in obese and overweight patients.
The most common side effects associated with Foundayo mirror those well-known to the GLP-1 class, including nausea, constipation, diarrhea, vomiting, and other gastrointestinal issues. The drug also includes a boxed warning about C-cell thyroid tumors and should not be used in patients with a personal or family history of medullary thyroid cancer or multiple endocrine tumor syndrome type 2, the FDA said in a statement.
According to the regulator, Foundayo is now the fifth product approved under the FDA’s new CNPV program and the first for the new molecular entity. The agency said the decision was “the earliest approval of a (new molecular entity) since 2002.”
The FDA introduced the program last year with the aim of significantly speeding up the review schedule for products that are in the U.S. national interest, but the pathway has already drawn scrutiny from lawmakers for potential corruption and rushed reviews. The FDA has scheduled a public hearing in June to solicit feedback on the program.
Eli Lilly and Novo Nordisk have made tens of billions of dollars in recent years with their respective metabolic blockbusters, and a series of new approvals for 2026 are now shaking up the field. Apart from the oral approval of the companies’ obesity drugs, Novo last month also won FDA approval for a higher-dose 7.2 mg form of injectable Wegovy. The company hopes it will help patients achieve better weight loss and plans to launch it in April.
Novo was the first to market both the injectable Wegovy and its tablet Wegovy, but the company has since ceded its lion’s share of the obesity market in the United States to Lilly.
Meanwhile, Lilly has been preparing for the launch of Foundayo for some time, indicating earlier this year that it had secured “pre-launch inventory” of investigational drugs worth $1.5 billion as of December 31, 2025, with much of that supply related to orforglipron.
