Federal regulators on Wednesday approved orforglipron, a GLP-1 drug developed by Eli Lilly to treat obesity and related conditions. The medication, which will be sold under the brand name Foundayo, is designed to mimic hormones that regulate appetite and feelings of fullness.

The FDA approved a faster review timeline, completing its evaluation in approximately 50 days as part of a program intended to accelerate drug approvals.

Eli Lilly said the drug is expected to begin shipping on Monday. With a company discount program, insured patients may pay as little as $25 per month, while cash-paying customers could face monthly costs ranging from $149 to $349, depending on dosage.

The pill enters a growing market of GLP-1 treatments, joining an oral option from Novo Nordisk. That company’s pill version of Wegovy has generated more than 600,000 prescriptions in the United States since its approval in December.

Clinical trial data involving more than 3,000 adults showed that patients taking the highest dose of orforglipron lost an average of 11.2% of their body weight, or about 25 pounds, over roughly 16 months. By comparison, participants receiving a placebo lost about 2.1%, or less than 5 pounds.

The weight loss results from both oral medications remain below those seen with injectable GLP-1 drugs. Eli Lilly’s injectable Zepbound has demonstrated average weight loss of about 21%, while Novo Nordisk’s injectable Wegovy averages around 15%.

Unlike some competing treatments, orforglipron can be taken without strict timing or dietary restrictions. Other oral GLP-1 drugs must be taken on an empty stomach with limited water intake and require patients to wait before eating.

In addition to weight loss, trial participants taking orforglipron showed improvements in several health markers, including waist circumference, blood pressure, cholesterol, and triglyceride levels.

Side effects were primarily gastrointestinal, with between 5% and 10% of participants discontinuing use, compared with nearly 3% in the placebo group.

Demand for GLP-1 drugs has surged in recent years, with about one in eight Americans reporting use of injectable versions, according to data from KFF. However, high costs have limited access for many patients.

The newly approved pill is expected to be included in a broader effort by the Trump administration to reduce prices for GLP-1 medications.