The FDA has approved Eli Lilly's oral GLP-1, Foundayo. Let the heated rivalry with oral Wegovy begin

Now it will be Foundayo (orforglipron) versus Wegovy (semaglutide) for market share in the market oral glucagon-like peptide 1 (GLP-1s).

Eli Lilly announced this morning that the FDA has, as was expected, approved its oral GLP-1, orforglipron, as treatment for obesity and that it will market the pill as Foundayo. The pill version of Novo Nordisk’s Wegovy was approved by the FDA in December 2025.

The products will compete on price. In today’s news release, Lilly said that Foundayo could cost as little as $25 per month with a Lilly-issued savings card and $149 per month for lowest dose for people paying out of pocket. The company says people with Medicare Part D coverage may be able to get Foundayo for $50 per month beginning in July.

Lilly and Novo Nordisk have transformed the landscape of chronic weight loss management with GLP-1 drugs while high demand has stressed payer budgets. The GLP-1s are incretin mimetics that, as the name suggests, imitate the action of the incretin hormone GLP-1 and, consequently, slow gastric emptying, stimulate insulin release and decrease glucose production by the liver while increasing its uptake by the muscles. Initially developed to treat type 2 diabetes, GLP-1s’ claim to fame lies in their ability to promote and maintain significant weight loss.

Available as a pill

Until recently, all the GLP-1 drugs approved by the FDA for weight management in patients with obesity or overweight have been formulated as subcutaneous injections that require temperature-sensitive storage and transportation. The self-administered injections are intended to be injected into the fatty tissue just under the skin. The recommended injection sites are the front of the thigh, the lower abdomen and the upper arm. The unprecedented popularity of the GLP-1s shows that the delivery route has not been a significant obstacle.

Even so, Foundayo and oral Wegovy pill might supercharge the demand for GLP-1s for weight loss. The Wegovy pill isn’t the first oral GLP-1. The FDA approved Novo Nordisk’s Rybelsus, a pill form of semaglutide, back in 2019.

Oral Wegovy offers an alternative to weekly injections in a convenient tablet formulation that is easier to store and distribute. GLP-1 injections must be stored and transported under refrigeration. The Wegovy tablets may be kept at room temperature. For the needle-averse, the new product offers an oral option with once-daily dosing.

In clinical trials, patients who took Wegovy tablets achieved an average 13.6% weight loss, with 79% of patients experiencing at least a 5% weight loss. Common side effects included nausea, diarrhea, vomiting, constipation and abdominal pain.

The wholesale acquisition cost for all doses of Wegovy tablets is $1,349.02 for a 30-day supply, the same as for a 4-week supply of the injections. In February, Novo Nordisk, a Danish company, announced it would cut the list prices of its semaglutide products in half next year as competition among GLP-1s heats up.

Currently, self-paying patients may be able to buy a one-month supply of Wegovy 1.5-mg or 4-mg tablets for $149 through the manufacturer’s direct-to-consumer NovoCare program. But that lower price is available only for new patients, and fine print on the website in late February said the discounted $149 price for the 4-mg pill would only last until April 15, 2026, when it would go up to $199. The $149 price for the 1.5-mg pill, which is not discounted, will stay the same.

Foundayo enters the fray

Foundayo differs from the Wegovy tablet in that it is a small nonpeptide molecule designed to be easier to manufacture and more readily absorbed by the body. In contrast, semaglutide, the active ingredient in Wegovy tablets, is a large peptide molecule that requires morning dosing with food and liquid restrictions for optimal absorption. In clinical trials, Foundayo was taken at any time of the day without regard to meals or liquids.

The ATTAIN-1 study was a phase 3 multinational, double-blind trial in which 3,127 participants were randomly assigned to receive once-daily doses of Foundayo 6-, 12-, or 36-mg tablets or placebo. The study evaluated the safety and efficacy of Foundayo in adults with obesity without diabetes. The primary end point was the percent change in body weight after 72 weeks. Secondary end points included the percentage of participants who had a body weight reduction of at least 5%, 10%, 15% or 20%.

Patients who took Foundayo were started at a dose of 1 mg and titrated up every four weeks until they reached their assigned dose. Each participant received counseling on eating a balanced diet and physical activity.

At 72 weeks, patients taking the 6-mg dose of the study drug lost a mean of 7.5% of their body weight, those taking the 12-mg dose lost a mean of 8.4% and patients in the 36-mg group lost a mean of 11.2%. In comparison, participants taking a placebo lost an average of 2.1% of their body weight. Additionally, a significantly greater percentage of participants who received any dose of Foundayo achieved at least a 5% decrease in body weight. Of those taking the highest dose (36 mg), 71.8% experienced weight loss of at least 5% compared with 26.8% in the placebo group.

Common adverse effects were mild to moderate and primarily gastrointestinal. The most frequent resembled those experienced with GLP-1s administered subcutaneously and included nausea, constipation, diarrhea, vomiting and dyspepsia. Five cases of mild pancreatitis were reported in the Foundayo groups, and no cases of medullary thyroid cancer. It is not talked about much, but all the FDA-approved GLP-1s have boxed warnings for the potential risk of medullary thyroid cancer.

Pills vs. injections

As more oral GLP-1s enter the market, they are predicted to capture over one-third of the GLP-1 weight management market. Although individual trials do not show that tablets are superior to injections for promoting weight loss, some patients may gravitate toward oral GLP-1s simply because of their ease of use and storage. This may be especially true given the similarities in side effect profiles.