Novo Nordisk says FDA decision on CagriSema expected by late 2026

Novo Nordisk says the US Food and Drug Administration is expected to decide on CagriSema by late 2026, and a pharmacy benefit manager's pipeline update names December as the month to watch ^[1][2]. CagriSema is a fixed-dose combination of cagrilintide 2.4 mg, a long-acting amylin analog, and semaglutide 2.4 mg, the same molecule sold as Ozempic, Wegovy and Rybelsus ^[2]. It is given once weekly by injection ^[2]. Novo Nordisk submitted it to the FDA in December 2025 for weight management, based on the REDEFINE 1 and REDEFINE 2 pivotal trials ^[2].

What the company reported in February

On February 23, 2026, Novo Nordisk reported headline results from REDEFINE 4, an open-label phase 3 trial that compared CagriSema with tirzepatide 15 mg — the molecule sold as Mounjaro and Zepbound — over 84 weeks ^[2]. The trial enrolled 809 randomized people with obesity and one or more other conditions, with an average starting weight of 114.2 kg, about 252 pounds ^[2].

Among people who adhered to treatment, CagriSema produced 23.0% weight loss at 84 weeks, compared with 25.5% for tirzepatide 15 mg ^[2]. Using the treatment-regimen analysis, which measures the effect regardless of whether people stayed on treatment, the numbers were 20.2% for CagriSema and 23.6% for tirzepatide ^[2]. The trial did not meet its primary endpoint of showing that CagriSema was non-inferior, or at least as good, as tirzepatide on weight loss at 84 weeks ^[2].

The company said CagriSema "appeared to have a safe and well-tolerated profile" in the trial. The most common side effects were gastrointestinal, "the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class," according to the announcement ^[2].

"We are pleased with the weight loss of 23% for CagriSema in this open-label trial," said Martin Holst Lange, executive vice president, R&D and chief scientific officer at Novo Nordisk ^[2]. He said CagriSema has the potential to be the first GLP-1/amylin combination product to reach the market for people living with obesity ^[2].

The REDEFINE 4 results are separate from the data package under FDA review. The company's application for weight management rests on REDEFINE 1 and REDEFINE 2, not REDEFINE 4 ^[2].

Why it matters for patients

If approved, CagriSema would add another treatment option and would be the first approved product that pairs a GLP-1 with an amylin analog for weight management ^[2]. Novo Nordisk describes it as the potential first GLP-1/amylin combination to reach the market for people living with obesity ^[2].

In REDEFINE 4, CagriSema produced less weight loss than tirzepatide 15 mg on both analyses reported, so how it compares with drugs already on the market is not settled ^[2].

The timeline carries uncertainty. "Late 2026" is Novo Nordisk's expectation, and December comes from a pharmacy benefit manager's pipeline update, not from the FDA ^[1][2]. The FDA has not publicly confirmed a decision date.

A US price for CagriSema has not been disclosed, and coverage decisions by insurers and pharmacy benefit managers have not been reported. Without that information, patients and prescribers cannot yet know what the drug would cost or how easily it could be filled at a pharmacy.

What happens next

The FDA decision is anticipated by late 2026, with December named in the pharmacy benefit manager update ^[1][2]. Novo Nordisk plans to start a phase 3 trial of a higher-dose combination, CagriSema 2.4 mg/7.2 mg, in the second half of 2026 ^[2]. REDEFINE 11, an 80-week trial of CagriSema 2.4/2.4 mg versus placebo in 600 adults with obesity, is expected to report data in the first half of 2027 ^[2]. CagriSema is also being studied as a treatment for type 2 diabetes in the REIMAGINE program, but those results are not part of the current FDA filing for weight management ^[2].