CagriSema's FDA decision date sets up a December catalyst

Novo Nordisk has told investors that the U.S. Food and Drug Administration is expected to decide on CagriSema for weight management by late 2026, after the company filed its application in December 2025 ^[2]. A pharmacy benefit manager pipeline tracker has since narrowed that window to December ^[1]. If cleared, CagriSema would be the first combination of a GLP-1 drug and an amylin analogue to reach the U.S. market for obesity ^[2].

CagriSema is a once-weekly injection that combines two molecules in one fixed dose: cagrilintide 2.4 mg, a long-acting amylin analogue, and semaglutide 2.4 mg, the same active ingredient in Wegovy and Ozempic ^[2]. Novo says the two work together by reducing hunger and increasing fullness so people eat less ^[2].

What the FDA is reviewing

The application is based on the REDEFINE 1 and REDEFINE 2 pivotal trials, which together enrolled about 4,600 adults with overweight or obesity ^[2]. REDEFINE 1 was a 68-week trial of CagriSema, cagrilintide alone and semaglutide alone against placebo in 3,417 adults with obesity or overweight plus at least one other health condition, without type 2 diabetes ^[2]. REDEFINE 2 was a 68-week trial in 1,206 adults who had type 2 diabetes along with obesity or overweight ^[2].

The headline numbers from those two trials are not restated in the February 2026 announcement, so the exact figures the FDA is weighing are not spelled out in the sources here.

The head-to-head result that complicates the picture

On February 23, 2026, Novo reported results from REDEFINE 4, an 84-week open-label trial that pitted CagriSema 2.4 mg/2.4 mg directly against tirzepatide 15 mg — the highest dose of the drug sold as Mounjaro and Zepbound ^[2]. The trial randomized 809 adults with obesity and one or more additional conditions, with a mean starting body weight of 114.2 kg (about 252 pounds) ^[2].

CagriSema did not meet its primary goal of showing it was not worse than tirzepatide on weight loss ^[2]. Among people who stayed on treatment, CagriSema produced 23.0% weight loss at 84 weeks versus 25.5% for tirzepatide ^[2]. Using the broader measure that counts everyone regardless of whether they stuck with treatment, the figures were 20.2% versus 23.6% ^[2].

Novo described CagriSema's safety profile in the trial as safe and well tolerated, with the most common side effects being gastrointestinal, mostly mild to moderate and easing over time — the pattern seen across the GLP-1 class ^[2]. Martin Holst Lange, Novo's R&D chief, said the company was "pleased with the weight loss of 23% for CagriSema in this open-label trial" and that cagrilintide "adds to the existing benefits of semaglutide" ^[2].

Because the trial was open-label, everyone involved knew which drug each participant was taking ^[2].

Why it matters for patients

A December decision would add a new option to a market where most approved weight-loss injections work through GLP-1 biology alone. CagriSema's pitch is that pairing amylin with semaglutide delivers more weight loss than semaglutide by itself ^[2].

At the same time, the REDEFINE 4 numbers show CagriSema at these doses landing below tirzepatide 15 mg on average weight loss in a direct comparison ^[2]. That head-to-head evidence is likely to shape how doctors and insurers view the drug even if the FDA approves it on the strength of the placebo-controlled REDEFINE trials.

Several practical questions are not answered in these sources: there is no announced U.S. brand name, no list price, no information about insurance coverage or supply, and no publicly confirmed FDA action date beyond "late 2026" ^[2] and the December reference in a pipeline update ^[1]. Novo's own language and the PBM tracker differ in how specific they are, so the exact decision day should be treated as unconfirmed until the FDA acts.

What happens next

• Second half of 2026: Novo plans to start a phase 3 trial of a higher-dose version, CagriSema 2.4 mg/7.2 mg, in adults with obesity ^[2].
• Late 2026, possibly December: FDA decision expected on CagriSema for weight management ^[1][2].
• First half of 2027: REDEFINE 11, an 80-week trial in 600 adults designed to test the full weight-loss potential of the 2.4/2.4 mg dose, is expected to report ^[2].

A separate cardiovascular outcomes trial, REDEFINE 3, is running in 7,000 adults with established heart disease and is event-driven, meaning its timing depends on how quickly events accumulate ^[2]. CagriSema is also being studied for type 2 diabetes in a program called REIMAGINE ^[2].