Wedoany.com Report-Dec.24, The U.S. Food and Drug Administration approved Novo Nordisk's oral weight-loss medication on December 22, 2025, marking the first oral GLP-1 therapy cleared for chronic weight management in adults with obesity or overweight and at least one weight-related health condition.

The Wegovy pill contains 25 milligrams of semaglutide, the same active ingredient as in the injectable versions of Wegovy and Ozempic. Novo Nordisk already offers an oral semaglutide product, Rybelsus, for type 2 diabetes management.

This approval follows results from the OASIS 4 trial, a 64-week late-stage study involving adults with obesity or overweight. Participants taking the 25 mg oral semaglutide once daily achieved an average body weight reduction of up to 16.6% (or around 13.6-17% depending on adherence), compared with about 2.2-2.7% for those on placebo.

The pill is taken daily in the morning on an empty stomach with water, requiring a 30-minute wait before consuming food, beverages, or other oral medications to support proper absorption.

Novo Nordisk has prepared production capacity in the United States, including facilities in North Carolina, to support the launch and avoid past supply constraints seen with the injectable Wegovy.

David Moore, Novo's executive vice president of U.S. operations, highlighted the potential benefits: a daily pill could increase interest and access for those preferring non-injectable options.

The starting dose of 1.5 mg will become available in early January 2026. The company has built supplies for broad availability.

Under a November agreement with the U.S. administration, Novo Nordisk and Eli Lilly will provide starter doses of approved weight-loss pills at $149 per month for Medicare, Medicaid participants, and cash-paying customers without insurance coverage.

Novo recently reduced the cash price for its injectable Wegovy to $349 per month from $499, with typical U.S. list prices exceeding $1,000 monthly.

The approval positions Novo Nordisk with a temporary lead in the oral segment, as Eli Lilly's orforglipron remains under review and could receive clearance as early as late March 2026.

Oral formulations are expected to broaden treatment access by addressing hesitancy toward injections, offering convenience such as no refrigeration needs and easier travel.

Analysts anticipate pills could account for a meaningful portion of the growing obesity treatment market, projected to reach substantial value in the coming decade, though they are unlikely to fully replace injectables.

"You're going to see a huge uptake in the patient base as new indications open up and as oral versions hit the market," said Anand Iyer, chief AI officer at telehealth firm Welldoc.

"The pills will not displace or replace the injections," said Christopher Chrisman, a managing director and partner at consultancy BCG, adding some patients may prefer to continue with weekly injections. "But pills offer clear advantages to some people. There's travel convenience and no need for a fridge," he added.

This step reflects continued advancement in options for managing obesity through effective, convenient therapies supported by diet and exercise.