Novo Nordisk files CagriSema with FDA
Novo Nordisk submitted a New Drug Application for CagriSema, a once-weekly shot combining cagrilintide with semaglutide, on Dec. 18, 2025, with FDA review expected in 2026 [1].
Novo Nordisk said on Dec. 18, 2025, that it has filed a New Drug Application with the U.S. Food and Drug Administration for CagriSema, a once-weekly injection that combines cagrilintide 2.4 mg, a long-acting amylin analogue, with semaglutide 2.4 mg, the GLP-1 receptor agonist sold as Wegovy and Ozempic [1][3]. The proposed use is chronic weight management alongside a reduced-calorie diet and more physical activity in adults with obesity, or overweight with at least one weight-related condition [1].
If the FDA clears it, CagriSema would be the first injectable product that pairs a GLP-1 receptor agonist with an amylin analogue in a single fixed-dose pen [1]. Amylin is a separate hormone pathway from GLP-1, and Novo Nordisk describes the combination as targeting "complementary obesity-related pathways" [1]. CagriSema is not approved in the United States or the European Union [1].
What the trials showed
The filing rests on two 68-week phase 3 trials. REDEFINE 1 randomized 3,417 adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) plus at least one obesity-related complication, and without diabetes, to CagriSema, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo [1]. REDEFINE 2 tested CagriSema against placebo in 1,206 adults with type 2 diabetes and obesity or overweight [1].
In REDEFINE 1, average weight loss at 68 weeks was 20.4% with CagriSema versus 3.0% with placebo when results were counted regardless of whether people stayed on treatment — the "treatment policy" analysis. Average starting weight was 236 pounds in the CagriSema group and 235 pounds on placebo [1]. In the alternative "trial product" analysis, which estimates what would happen if everyone stayed on the drug and used no other weight-loss therapy, the figures were 22.7% versus 2.3% [1]. Novo Nordisk's release highlights the 23% figure in its summary bullets [1]. One trade report described the 20.4% result as consistent whether or not patients stayed on treatment, which blurs the distinction between the two analyses spelled out in the company's own release [1][2].
About 91.9% of CagriSema participants lost at least 5% of body weight, versus 31.5% on placebo [1]. In a supportive secondary analysis, 54% of participants who had obesity at the start dropped below a BMI of 30 by week 68, compared with 11.1% on placebo [1].
Side effects were mostly digestive and in line with what is already known about the GLP-1 class, according to the company [1]. In REDEFINE 1, gastrointestinal adverse events occurred in 79.6% of the CagriSema group versus 39.9% on placebo, including nausea (55% vs. 12.6%), constipation (30.7% vs. 11.6%) and vomiting (26.1% vs. 4.1%) [1]. Dropouts due to side effects were 5.9% with CagriSema versus 3.5% with placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2 [1].
Why it matters for patients
A filing is not an approval, and nothing about CagriSema is available by prescription today [1]. Still, the submission signals that the next wave of obesity drugs may move beyond single-hormone incretins. The REDEFINE 1 design included semaglutide 2.4 mg and cagrilintide 2.4 mg as separate comparison arms, which means head-to-head data against semaglutide alone exist in the published trial — though the company's announcement reports only the placebo comparisons, so the size of any added benefit over semaglutide is not stated in these sources [1].
The nausea, vomiting and constipation rates give a sense of what tolerability discussions might look like, and the low discontinuation rates suggest most participants stayed on treatment [1]. Price, insurance coverage, supply and how CagriSema would fit alongside existing options are not addressed in the announcement and are not yet known.
What happens next
Novo Nordisk says the FDA is expected to review the application in 2026 [1][2]. Neither the company's release nor the trade coverage lists a target action date, and no advisory committee meeting has been announced in these sources [1][2][3]. Longer-term studies continue: REDEFINE 3 is an event-driven cardiovascular outcomes trial, and REDEFINE 11 is a longer trial in people with a BMI of 30 or higher [1]. CagriSema is also being studied for type 2 diabetes under a separate program called REIMAGINE [1].
Sources
- https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html
- https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema
- https://www.drugs.com/nda/cagrisema_251222.html
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