Eli Lilly wins FDA approval for weight loss pill, boosts rival Novo – Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Eli Lilly’s orforglipron pill for weight loss, ending Novo Nordisk’s first mover profits in the US after just three months.

Oral glucagon-like peptide-1 receptor agonist (GLP-1RA) will be branded under the name Foundayo. Lilly expects to launch the drug in the direct-to-consumer channel by April 6, with availability to retail pharmacies and telehealth providers soon after.

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The FDA based its decision on the results of the ATTAIN clinical program, which showed that patients taking the highest dose of Foundayo who remained on treatment lost an average of 12.4% of their body weight.

The approval marks the first new molecular entity (NME) approved under the FDA’s national priority voucher (CNPV) program. The regulatory path launched by Commissioner Marty Makary to speed up approval for drugs that show potential is centered in the US.

GlobalData senior analyst Shehroz Mahmood said: “The FDA approval of Foundayo (orforglipron) marks a pivotal moment in the oral GLP-1RA obesity space and validates the CNPV program, which has led to the approval of new molecular entities since 2002.”

Oral GLP-1RA competitors continue

FDA approval for Foundayo brings it into direct competition with Novo’s pill Wegovy (semaglutide), which was launched in the US in January 2026. While uptake for Novo’s products has been strong, analysts say market dynamics will hinge on several key factors.

First, the advantage of Foundayo is that it does not have food restrictions with the administration. Oral Wegovy, on the other hand, should be taken on an empty stomach every morning. Lilly also has an edge in supply chain logistics. As a small molecule, Foundayo has a more straightforward manufacturing process and scalability compared to Wegovy, which is a peptide-based therapy. However, Novo does not have the upper hand in the efficacy front. While no head-to-head direct trials have been conducted, the Wegovy pill on average causes 2.2% better weight loss.

Mahmood commented: “In general, Lilly faces different competitive challenges than the era of injectables, where the efficacy advantage allows Zepbound to overcome Wegovy’s first mover advantage – the oral battlefield instead of depending on manufacturing scalability, direct-to-patient marketing reach, and cash-price strategy, among others, each of which carries strategic weight.

The oral GLP-1RA market represents the next battleground for Lilly and Novo. The former won out in the injectable arena due to high efficacy and strong uptake for Mounjaro and Zepbound. Driven by obesity drug sales, Lilly’s growth is expected to rise 45% in 2025, in contrast to less favorable financial results for Novo. Despite reaching the US oral obesity market first, Citi analysts predict that Foundayo’s lack of fasting requirements will put it in pole position to continue Lilly’s cardiometabolic dominance.

Citi analysts said in a research note: “Despite launching second behind Novo’s Wegovy pill, we think that Foundayo is easier to use than offset its 2.2% efficacy deficit and position it to capture the lion’s share of this fast-growing market.”

GlobalData’s patient-based forecast predicts that Foundayo will generate $14.8bn in global obesity sales in 2031.

GlobalData is the parent company of Pharmaceutical Technology.

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