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Lilly's Foundayo enters oral GLP-1 market

Lilly's Foundayo enters oral GLP-1 market

Lilly's FDA approval of Foundayo puts it in direct competition with Novo Nordisk's oral Wegovy. Back home, Indian companies are lining up their own GLP-1 bets from generics to novel molecules

Neetu Chandra Sharma
Neetu Chandra Sharma
  • Updated Apr 3, 2026 2:56 PM IST
Lilly's Foundayo enters oral GLP-1 marketLilly's Foundayo approved by FDA, escalating the race with Novo Nordisk in the obesity drug market

The US Food and Drug Administration approved Eli Lilly's Foundayo (orforglipron) on April 1, 2026, a once-daily oral GLP-1 pill for weight loss, intensifying the competition between Lilly and Danish drug maker Novo Nordisk that has defined the obesity drug market for the past several years.

Novo Nordisk had moved first, winning FDA approval for the Wegovy pill, once-daily oral semaglutide 25 mg in December 2025, making it the first oral GLP-1 receptor agonist approved for weight management. Novo launched in January 2026. Lilly's approval, roughly three months later, now puts two oral pills in the same market, and the two companies are wasting no time drawing distinctions.

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The sharpest one is on dosing convenience. The Wegovy pill must be taken on an empty stomach with a small amount of water, and patients are directed not to eat, drink or take other medicines for 30 minutes after taking it, a restriction that doctors say has already limited uptake of Rybelsus, Novo's older oral semaglutide approved for diabetes. Foundayo, a small molecule non-peptide drug structurally different from semaglutide, carries no such restriction. It can be taken at any time of day, with or without food.

"For many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," said Deborah Horn, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston.

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On efficacy, Novo's trial data hold an edge. Oral Wegovy demonstrated 16.6% mean weight loss when treatment was adhered to in the OASIS 4 trial. Foundayo's ATTAIN-1 trial showed 12.4% average weight loss on the highest dose among patients who stayed on treatment, with an average loss of 27.3 pounds compared to 2.2 pounds on placebo.

On price, both companies have anchored their lowest dose at $149 per month for self-pay patients, though Novo's $149 price for the 4 mg tablet is only available until April 15, 2026, after which it rises to $199. Lilly has said patients with commercial insurance can access Foundayo for as little as $25 per month and has flagged a $50 per month Medicare Part D option from July 2026. Lilly has also submitted orforglipron for approval in more than 40 countries, with plans to launch in each market shortly after clearance.

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The competition between the two is not just about pills. Both companies have spent the last two years dominating the injectable GLP-1 market, Novo with Wegovy and Ozempic, Lilly with Zepbound and Mounjaro, and their oral entries are an extension of that rivalry into a format that could reach patients who were unwilling or unable to self-inject. David Ricks, chair and CEO of Eli Lilly, noted at the time of approval that fewer than one in ten people who could benefit from a GLP-1 are currently taking one.

In India, the GLP-1 story is playing out on a different timeline. The immediate opportunity for domestic companies is generic semaglutide, unlocked by patent expiry in early 2026. Torrent Pharmaceuticals moved first. In March 2026, the company announced the launch of its semaglutide brands Sembolic and Semalix  in both oral and injectable formulations, becoming the first Indian company to offer semaglutide across both forms. Amal Kelshikar, CEO, India Business, Torrent Pharma, said, "We are the first Indian company to offer this treatment across oral and injectable formulations, giving healthcare professionals a holistic choice for treating patients." Torrent priced its injectable formulation at Rs 3,999 per month, a significant reduction from the Rs 17,000–26,000 monthly price of branded semaglutide.

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It is pertinent to note that Torrent's oral semaglutide generic still carries the same food and water restrictions as Rybelsus; it is the molecule, not just the brand, that requires fasting. As of early 2026, oral semaglutide in India is approved only for the management of type 2 diabetes, not for weight loss.

Beyond generics, a handful of Indian companies are working on novel molecules. Mankind Pharma is developing MKP10241, a small-molecule oral obesity drug. The drug is currently in Phase 2 trials in Australia. Arjun Juneja, COO at Mankind Pharma, told Business Today: "We have seen very promising Phase 1 results and have recently started Phase 2 trials in Australia. If successful, this product could become the first small-molecule drug for obesity treatment, as all existing options are peptides. Moreover, it would be the only orally available product in this category, with no food-related restrictions."

Sun Pharma, meanwhile, is advancing its investigational GLP-1 molecule Utreglutide, with a target launch horizon of four to five years and has secured Phase 3 approval for semaglutide trials in India.

Published on: Apr 3, 2026 2:56 PM IST
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