Danish pharmaceutical giant Novo Nordisk has formally submitted its combination drug CagriSema to the U.S. Food and Drug Administration (FDA) for regulatory review. The submission, made on December 18, 2025, marks a pivotal strategic move for the company as it aims to regain momentum in the highly competitive obesity treatment market.
A Critical Juncture for the Market Leader
This regulatory filing arrives at a challenging time for Novo Nordisk. The company’s shares have faced significant pressure, declining more than 50% since the start of the year. Intensifying competition from Eli Lilly’s rival therapies, Mounjaro and Zepbound, has eroded market share. Furthermore, an estimated one million patients in the United States have turned to more affordable compounded versions of weight-loss medications.
In response to these headwinds, management has revised its 2025 financial outlook downward multiple times, now projecting sales growth of just 8 to 11 percent. A concurrent restructuring initiative is underway, targeting the elimination of approximately 9,000 positions by the end of 2026. This program is expected to yield annual savings of 8 billion Danish kroner.
The Science Behind CagriSema
The investigational therapy combines two distinct mechanisms of action: semaglutid 2.4 mg, the active ingredient in Wegovy and Ozempic, and cagrilintid 2.4 mg, a novel amylin analog. By targeting multiple metabolic pathways simultaneously, the combination is designed to be more effective than single-agent treatments.
Clinical trial data from the Phase 3 REDEFINE 1 study underscores its potential:
* Participants experienced an average weight reduction ranging from 22.7 to 23 percent.
* Notably, 40.4 percent of trial subjects lost 25 percent or more of their body weight.
* This compares to a mere 0.9 percent of participants in the placebo group achieving the same threshold.
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A separate study, REDEFINE 2, focused on patients with Type 2 diabetes. Results showed a mean weight loss of 15.7 percent for those on CagriSema, versus 3.1 percent for the placebo cohort. The safety profile remained consistent with the established GLP-1 drug class, with discontinuation rates due to side effects reported between 5.9 and 8.4 percent.
Pipeline Progress and Strategic Acquisitions
Alongside the CagriSema submission, Novo Nordisk is advancing other key initiatives. In December, the European Medicines Agency (EMA) issued a positive opinion for a higher-dose 7.2 mg formulation of Wegovy. A regulatory decision on this version in the U.S. is anticipated under a fast-track review in the first quarter of 2026.
The company has also bolstered its research pipeline through acquisition, completing a $4.7 billion takeover of Akero Therapeutics earlier this month.
Awaiting the Verdict
The FDA is expected to review the CagriSema application throughout 2026. A successful approval would grant Novo Nordisk the first-ever sanctioned combination therapy pairing a GLP-1 agonist with an amylin analog for weight management. The outcome is seen as a crucial factor in the company’s ongoing rivalry with Eli Lilly for dominance in the obesity drug sector.
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