FDA Approves First Oral GLP-1 Drug from Eli Lilly
▼ Summary
– The FDA approved Eli Lilly’s new once-daily obesity pill, Foundayo, which is a GLP-1 medication similar to Ozempic and Wegovy.
– It is the second GLP-1 weight-loss pill on the market, differing from Novo Nordisk’s Wegovy pill as it can be taken any time of day without food restrictions.
– Pills are being developed to meet high demand, as they may be preferable to injections for some patients and are easier to manufacture, which could alleviate shortages.
– In an 18-month trial, the highest dose of Foundayo led to an average weight loss of 27 pounds, and it helped maintain weight loss for people switching from injectable GLP-1 drugs.
– Foundayo was approved under an expedited FDA review program and is available through LillyDirect, with broader pharmacy availability coming soon.
A new oral medication for chronic weight management has received clearance from US regulators, marking a significant shift in the treatment landscape. The Food and Drug Administration has approved Eli Lilly’s Foundayo, a once-daily pill that represents the company’s first oral entry into the competitive GLP-1 drug category. This approval introduces a convenient alternative to the injectable therapies, like Lilly’s own Zepbound, that have surged in popularity.
Foundayo functions as a GLP-1 receptor agonist, mimicking a natural hormone that helps regulate blood sugar, slows stomach emptying, and promotes feelings of fullness. It becomes the second oral GLP-1 option for weight loss, following the approval of Novo Nordisk’s pill version of Wegovy in December. A key differentiator is administration; while the Wegovy pill requires a morning dose on an empty stomach, Foundayo can be taken at any time of day without food or water restrictions.
The development of oral formulations addresses several critical challenges. The massive demand for injectable GLP-1s led to severe shortages from late 2022 into early 2025, straining manufacturing capacity. Pills are generally easier to produce at scale, which could help ensure more reliable patient access. Perhaps more importantly, an oral option may overcome patient reluctance toward injections. “Beyond supply and affordability, one of the bigger barriers to adoption has been that some patients just don’t want to take an injection,” said Ken Custer, an executive vice president at Eli Lilly. “For patients looking to get started with their weight management journey, maybe a pill is an easier place for them to start.”
The safety and dosing profile mirrors that of injectables. Treatment with Foundayo begins at a low dose, which is gradually increased over time to help mitigate common gastrointestinal side effects such as nausea and diarrhea. In a pivotal clinical trial, participants taking the highest dose over 18 months lost an average of 27 pounds, or 12.4 percent of their starting body weight. Those on a placebo lost only 2 pounds. For context, Novo Nordisk’s oral Wegovy demonstrated an average weight loss of 13.6 percent over 16 months in its studies, though no direct comparative trials between the two pills have been conducted.
Research also indicates Foundayo can help maintain weight loss for individuals switching from an injectable therapy. A Lilly study found that patients who switched from injectable Wegovy to Foundayo regained an average of only 2 pounds. Those switching from Lilly’s more potent injectable Zepbound regained an average of 11 pounds. The active ingredient in Foundayo, orforglipron, is also under investigation as a potential treatment for type 2 diabetes, obstructive sleep apnea, and osteoarthritis knee pain.
The FDA reviewed Foundayo under an accelerated pilot program designed to fast-track drugs that align with national health priorities, granting approval in just 50 days compared to the typical six to 10 month review period. The pill is now available through Lilly’s direct-to-consumer platform, LillyDirect, with shipments starting April 6. A broader rollout to US retail pharmacies and telehealth providers will follow shortly. Foundayo was also included in a November 2025 agreement to be offered via the TrumpRx platform, expanding its potential distribution channels.
(Source: Wired)
