Eli Lilly’s Oral Obesity Pill Approved, Kicking Off Renewed Novo Rivalry

 

The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.

Look out, Novo Nordisk, the competition has arrived. Wednesday, the FDA signed off on one of the most anticipated new drugs of 2026: Eli Lilly’s obesity pill orforglipron, now to be known as Foundayo.

Lilly, which has already amassed $1.5 billion worth of Foundayo, plans to launch the product quickly. In its announcement on Wednesday, the company said Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning on April 6. The drug will be available for $25 per month with commercial coverage, and $149 per month for those who choose the self-pay option.

Notably, Foundayo is also the fifth drug to be approved under the FDA’s new Commissioner’s National Priority Voucher Program. Introduced in June 2025, the CNPV program is intended to expedite the usual 10–12 month review time to 1–2 months for products that align with certain national priorities. By this timeline, Foundayo should have been approved by March 28, according to reporting from Reuters in January.

In its announcement, the FDA noted that Foundayo was approved 50 days after filing, and 294 days before the PDUFA date of January 20, 2027.

The approval of Foundayo is expected to be a pillar of Lilly’s weight loss and diabetes franchise, which consists of the diabetes drug Mounjaro, the weight management brand Zepbound and now Foundayo. The trio could net Lilly $101 billion in peak worldwide revenue, Truist Securities said in November 2025. This estimate is based on 17.6 million people around the world eligible for one of the therapies and assumes a price of $200 per month.

The firm’s estimate followed a deal with the White House struck by Lilly and Novo in November, part of which would see initial doses of Foundayo sold at $150. That price was also meant to be applied to Novo’s oral Wegovy, which won approval the following month and entered the U.S. market in January.

The pricing scheme appeared to be effective for Novo as oral Wegovy got off to a strong start, with nearly 3,100 patients reached in its first week of sales. Despite the strong launch, analysts warned upon the product’s approval that oral Wegovy would soon see competition in the form of Lilly’s forthcoming product and other oral candidates.

Recent clinical results suggest Foundayo could ultimately overtake Novo’s oral offering. In the Phase 3 ACHIEVE-3 study, reported in February, Foundayo elicited greater weight loss and better glycemic control than oral semaglutide—marketed as Rybelsus for diabetes—in patients with type 2 diabetes whose condition is inadequately controlled by metformin.

Foundayo also holds a manufacturing advantage over its key competitor. As a small molecule, Foundayo is easier to manufacture than oral Wegovy, which is a peptide. A small molecule “could be potentially influential in the fight for the oral obesity market,” Evan Seigerman told BioSpace in August 2025.”

The approval of Foundayo was supported by data from the Phase 3 ATTAIN-1 trial, in which the highest 36 mg dose produced an average weight loss of 27.3 lbs at 72 weeks. The drug also led to “significant improvements across key cardiometabolic risk factors,” according to a September 16 press release issued by Lilly. In comparison, 25 mg of oral Wegovy elicited 16.6% mean weight loss in the OASIS 4 trial, according to Novo’s approval announcement. in which the highest 36 mg dose of Foundayo produced an average weight loss of 27.3 lbs at 72 weeks. The drug also led to “significant improvements across key cardiometabolic risk factors,” according to a September 16 press release issued by Lilly. In comparison, 25 mg of oral Wegovy elicited 16.6% mean weight loss in the OASIS 4 trial, according to Novo’s approval announcement.

The drug’s label includes a boxed warning for thyroid C-cell tumors, according to the FDA’s announcement, which also said Foundayo should not be used in patients with a personal or family history of medullary thyroid cancer or in those with Multiple Endocrine Neoplasia syndrome type 2.

Foundayo’s approval is the latest factor in a tight market battle between Novo and Lilly. It’s a race Lilly is currently winning, as Mounjaro earned $22.965 billion in sales last year, compared to Ozempic’s $20.1 billion.

https://www.biospace.com/fda/eli-lillys-oral-obesity-pill-approved-kicking-off-renewed-novo-rivalry