The brief reign of Novo Nordisk’s Wegovy pill as the lone oral GLP-1 approved for obesity has ended as Eli Lilly’s orforglipron cruised past an FDA green light Wednesday.
Now christened Foundayo, the FDA has approved Lilly’s GLP-1 receptor agonist pill as the first new molecular entity cleared under the regulator’s controversial Commissioner’s National Priority Voucher (CNPV) program, according to an April 1 announcement from the agency.
With the nod—which covers Foundayo alongside a reduced-calorie diet and increased exercise in adults with obesity or who are overweight with weight-related medical problems—Lilly plans to offer the pill via its cash-pay consumer drug purchasing platform LillyDirect and is accepting prescriptions immediately, with shipping slated to begin on April 6, according to a company press release.
Lilly said it expects the drug to be broadly available through U.S. retail pharmacies and telehealth providers “shortly after” the LillyDirect launch.
Both Lilly and Novo have been making strides to improve the affordability of their incretin meds for diabetes and weight loss in recent years, and that strategy is on full display in Lilly’s Foundayo pricing strategy.
For those with commercial insurance, patients could pay as little as $25 per month for the pill with a savings card, and people choosing to self-pay can access the lowest Foundayo dose at $149 a month, per Lilly. That Foundayo price point, as advertised, matches up with Novo’s Wegovy pill, which launched on Jan. 5.
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment,” Lilly CEO David Ricks said in a statement. “We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications.”
The FDA based its approval on data from Lilly’s ATTAIN clinical program. In the ATTAIN-1 study, patients on the highest dose of Foundayo and who took the treatment as intended lost an average of 27.3 pounds, or 12.4% of their average body weight, versus 2.2 pounds (0.9%) for those who received placebo, Lilly noted in its approval announcement.
Though comparisons across trials carry inherent flaws, Novo’s Wegovy pill won a U.S. green light based on data showing an average 16.6% weight loss among patients who adhered to treatment.
In Lilly’s program, patients taking Foundayo regardless of trial completion lost an average of 25 pounds or 11.1% of their average body weight versus 5.3 pounds (2.1%) among their counterparts in the control arm. Lilly’s clinical program also pointed to Foundayo’s potential to 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 between Foundayo and its own Wegovy pill on Wednesday.
“Not all GLP-1s are the same. Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading,” Novo’s EVP of U.S. operations, Jamey Millar, said in an emailed statement. “There is no head-to-head trial comparing the efficacy of orforglipron and Wegovy pill, and Wegovy pill has demonstrated a magnitude of weight loss no other oral GLP-1 obesity candidate by itself, as a singular molecule, has shown in a Phase 3 study without the benefit of another agent.”
Millar added that, among approved obesity meds, only Wegovy can currently boast “proven” claims that it also reduces the risk of major adverse cardiovascular events like death, heart or stroke in patients with obesity or who are overweight.
The most common side effects associated with Foundayo mirror those familiar to the GLP-1 class, including nausea, constipation, diarrhea, vomiting and other gastrointestinal issues. The drug also includes a boxed warning for thyroid C-cell tumors and shouldn’t be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2, the FDA cautioned in its release.
Foundayo now marks the fifth product approved under the FDA’s new CNPV program and the first for a new molecular entity, according to the regulator. The decision also marks the “fastest approval of a [new molecular entity] since 2002,” per the agency.
The FDA introduced the program last year in a bid to significantly accelerate review timelines for products aligned with U.S. national interests, but the pathway has already attracted lawmaker scrutiny about the potential for corruption and rushed reviews. The FDA has scheduled a public hearing for June to solicit feedback on the program.
As Eli Lilly and Novo Nordisk have raked in tens of billions of dollars with their respective metabolic blockbusters in recent years, a series of new approvals in 2026 is now shaking up the field. Aside from the companies’ respective oral approvals in obesity, Novo last month also won an FDA nod for a high dose, 7.2-mg format of injectable Wegovy, which the company is hoping can help patients achieve superior weight loss, with plans to launch in April.
While Novo was first to market with both injectable Wegovy and its Wegovy pill, the company has subsequently ceded its superior obesity market share in the U.S. to Lilly.
For its part, Lilly has been gearing up for its Foundayo launch for some time, indicating earlier this year that it had secured “pre-launch inventories” of investigational meds worth $1.5 billion as of Dec. 31, 2025, with much of that supply tied to orforglipron.
