WASHINGTON, D.C.: Eli Lilly has secured U.S. approval for its weight-loss pill, marking a major step into the growing obesity treatment market and setting up a new phase of competition with rival Novo Nordisk.

The U.S. Food and Drug Administration approved Lilly's drug, orforglipron, to be sold under the brand name Foundayo. It is a once-daily oral medication that targets the appetite-suppressing GLP-1 hormone.

Lilly said the drug will begin shipping on April 6 through its LillyDirect program and will cost $149 per month for the lowest dose for self-pay customers, in line with Novo's pill. It will later be available through retail pharmacies and telehealth providers.

The approval strengthens Lilly's position in the emerging obesity-pill segment, following its lead over Novo Nordisk in injectable treatments.

Novo was first to market with GLP-1 medicines, including Ozempic for diabetes and Wegovy for obesity, but has faced mounting competition from Lilly as well as pressure from compounded versions of the drugs.

Lilly's pill offers a convenience advantage, as it can be taken at any time of day without restrictions. In contrast, Novo's pill must be taken first thing in the morning and at least 30 minutes before food, water or other medications.

Lilly's injectable tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight loss, works through a dual mechanism that mimics both GLP-1 and GIP hormones.

Shares of Lilly rose nearly 5% following the approval, while U.S.-listed shares of Novo fell nearly 2%.

Weight loss results and safety profile

Oral weight-loss drugs are not expected to replace injectables entirely, but analysts estimate pills could account for about 20% of the market by 2030, particularly among patients who prefer pills over injections.

In a 72-week late-stage trial, orforglipron helped overweight patients lose about 12% of their body weight, with results plateauing for most participants.

In a 36-week midstage trial, the drug led to nearly 15% weight loss without an apparent plateau.

The most commonly reported side effects were mild-to-moderate gastrointestinal issues such as nausea and vomiting.

Foundayo carries a boxed warning — the FDA's most serious label — highlighting an increased risk of thyroid C-cell tumors. Novo's oral and injectable Wegovy include the same warning.

Fast-tracked approval

The drug received a voucher under the Commissioner's National Priority voucher program, which is designed to speed up reviews for medicines with significant public health or national security importance.

Lilly obtained the voucher as part of an agreement with the Trump administration to reduce prices of its weight-loss treatments for government programs and cash-paying patients.

FDA Commissioner Marty Makary said the review process maintained the same level of rigor as a standard evaluation.

"What we're doing is convening the different people at the agency that review parts of the application," he said.