Novo Nordisk Gains Ground as FDA Clears First Oral GLP-1 Therapy for Weight Loss

The U.S. Food and Drug Administration has authorized Novo Nordisk’s oral version of Wegovy, making the Danish pharmaceutical group the first company to secure clearance for a glucagon-like peptide-1 (GLP-1) pill specifically indicated for chronic weight management. The decision, announced late Monday, lifted Novo Nordisk’s share price by 9.2% in Tuesday trading and provided a rare boost during what has been the stock’s most challenging year on record.

First-mover position in a rapidly expanding market

The approved capsule delivers 1.5 milligrams of semaglutide, the same active ingredient found in the injectable form of Wegovy that reached the U.S. market in 2021. Novo Nordisk plans to launch the tablet—informally dubbed “Wegovy-in-a-pill”—in the United States, its largest market, in early January 2026. Regulatory filings have also been submitted to the European Medicines Agency and other authorities worldwide.

Patients with overweight or obesity will be able to obtain the starting dose through retail pharmacies and selected telehealth providers for $149 per month with savings programs, the company said. Under a pricing arrangement finalized last month, the same rate will apply to cash-paying customers ordering through TrumpRx, a direct-to-consumer website backed by former U.S. President Donald Trump. Drug affordability has remained a national focus as policymakers look for ways to curb out-of-pocket costs.

Because the oral formulation must be taken on an empty stomach, physicians may weigh convenience against efficacy when choosing between products. Novo Nordisk has stated that the restriction—patients should wait roughly 30 minutes before eating—should not pose a major obstacle to adherence.

Competition with Eli Lilly intensifies

Eli Lilly has filed its own oral GLP-1 candidate, orforglipron, with the FDA and expects a decision in March or April 2026. In a late-stage trial, Lilly’s pill produced average weight loss of 12.4% over about one year. Novo Nordisk’s semaglutide capsule demonstrated a 16.6% reduction in body weight across a comparable time frame.

Both companies are already vying for dominance in injectables. Novo Nordisk’s Ozempic, approved for type 2 diabetes in 2017, held a multiyear head start against Lilly’s Mounjaro. Despite that advantage, Lilly recently surpassed Novo Nordisk in U.S. prescription volumes as supply constraints limited availability of Ozempic and Wegovy, opening the door for compounding pharmacies and alternative providers.

Analysts note that the first-to-market position in oral treatments does not guarantee long-term leadership. Lilly’s maintenance study showing a seamless transition for patients moving from its injectable Zepbound or Wegovy to orforglipron could help the Indianapolis-based group retain share once both tablets are available.

Relief after a difficult 2025

The FDA decision arrives after a tumultuous 12 months for Novo Nordisk. The company issued multiple profit warnings, announced workforce reductions, underwent changes in senior management, and engaged in a high-profile—and ultimately unsuccessful—bidding contest with Pfizer. These setbacks contributed to a roughly 50% decline in Novo Nordisk’s share price in 2025, the steepest annual fall since the firm listed.

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Market observers characterized the FDA clearance as a turning point. Danish lender Jyske Bank called the outcome a “welcome Christmas gift” for shareholders and for patients who often initiate weight-loss programs at the start of a new year. HSBC analysts highlighted that the safety and tolerability profile observed in trials could give the semaglutide pill an edge, though they cautioned that execution on supply and commercialization will be decisive.

Indication spans weight loss and cardiovascular risk

The FDA label covers both long-term weight management and reduction of major adverse cardiovascular events, including heart attack and stroke, for adults who meet the eligibility criteria. The broader indication mirrors that of the injectable version, underscoring the growing recognition of GLP-1 drugs as tools not only for weight reduction but also for improving cardiac outcomes.

A surge of industry activity underscores the segment’s commercial potential. Pfizer, AstraZeneca, and Roche are among the large pharmaceutical groups pursuing their own oral or injectable obesity therapies. Research firm McKinsey estimates the global market for anti-obesity medications could exceed $100 billion annually within a decade.

Next steps

With U.S. launch preparations under way, Novo Nordisk must scale manufacturing to avoid the supply shortages that have constrained its injectable products. The company has not disclosed production capacity figures but said it is investing in additional facilities to meet anticipated demand.

Investors will monitor early prescription trends once the pill becomes available, the speed of international approvals, and the progress of Lilly’s orforglipron review. Pipeline developments from competing drugmakers also remain in focus as the scramble for share in the obesity market accelerates.

Crédito da imagem: CNBC