Novo Nordisk Secures Landmark FDA Approval for Oral Weight-Loss Drug

In a significant regulatory victory, Danish pharmaceutical giant Novo Nordisk has received U.S. Food and Drug Administration (FDA) approval for an oral tablet version of its weight-management therapy, Wegovy. This authorization marks the first oral GLP-1 treatment for chronic weight management available in the United States, potentially reshaping the competitive landscape. The company's shares responded positively, climbing nearly 8% in after-hours trading following the announcement. This development arrives after a challenging period for the stock, which has seen its value decline by over 40% this year.

The newly approved medication is a 25 mg semaglutide tablet designed for once-daily administration. Its approval eliminates the need for weekly injections, a key barrier for many patients hesitant about injectable therapies. This oral formulation could dramatically expand patient access.

Regulatory clearance was granted based on positive outcomes from the Phase 3a OASIS 4 clinical trial, which involved 307 adults over a 64-week period. The study data revealed compelling results:
* Participants experienced an average weight reduction of 16.6%.
* Approximately one in three subjects lost 20% or more of their body weight.
* The tablet demonstrated comparable efficacy to the injectable form of Wegovy.

The treatment is indicated for adults classified with obesity or who are overweight and have at least one weight-related comorbid condition, such as hypertension or type 2 diabetes.

Gaining a Crucial First-Mover Advantage

Novo Nordisk has strategically positioned itself to capitalize on this approval, announcing plans for a U.S. commercial launch in early January 2026. The company has undertaken advance production at its facility in North Carolina to ensure adequate supply from the outset.

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This timeline provides a critical head start against rival Eli Lilly, which could see its competing oral drug, orforglipron, receive FDA approval around the end of March 2026. The race for market share is intensifying within a global weight-management sector projected to reach an annual value of $150 billion by 2030. Industry researchers estimate oral formulations could capture roughly 20% of this expansive market.

A Timely Boost After a Difficult Period

The FDA decision comes at a pivotal moment for Novo Nordisk. Throughout 2025, the company's equity has faced substantial pressure, falling from over $85 per share at the start of the year to a recent level near $52. Competitor Eli Lilly’s drug, Zepbound, surpassed Wegovy in terms of weekly U.S. prescription volumes, leading Novo Nordisk to issue profit warnings.

The oral tablet directly addresses a significant market gap. While around 40% of U.S. adults are affected by obesity, only about 12% currently use GLP-1 medications. The pill format is expected to bridge this adoption chasm, appealing to patients who have been reluctant to use injectable therapies.

Looking ahead, Novo Nordisk has submitted applications for the oral therapy to the European Medicines Agency (EMA) and other international regulators in the second half of 2025. The coming months will determine whether this first-mover advantage and expanded treatment modality can help the company regain its footing in the high-stakes obesity drug market.