Is CagriSema FDA-approved, and what does the research show?

What is CagriSema?

CagriSema is Novo Nordisk's name for cagrilintide and semaglutide given together as one weekly injection ¹. The company calls it a fixed-dose combination: both drugs sit in a single product in set amounts, rather than being prescribed separately ¹. Semaglutide is the GLP-1 receptor agonist FDA has approved as Wegovy for weight management and as Ozempic for type 2 diabetes ⁷, ⁸. Cagrilintide copies amylin, a pancreatic hormone that "induces satiety," in a long-acting, laboratory-made form ⁹.

Is CagriSema FDA-approved?

CagriSema is not FDA-approved: Drugs@FDA lists no approved CagriSema or cagrilintide product as of November 9, 2026 ². Novo Nordisk has applied for approval. It submitted a New Drug Application on December 18, 2025 ¹. The application is for reducing excess body weight and keeping it off in adults with obesity, or with overweight and at least one weight-related condition ¹.

The company has given two forecasts for FDA's answer. In its financial report dated February 3, 2026, the company said it expected the review "to be completed around the turn of the year 2026/2027" ¹⁰. On September 30, 2026, it said "A decision is expected in Q4 2026" ³. Those dates are the company's expectations, not FDA's.

The two drugs stand differently with FDA. Semaglutide can be prescribed today as Wegovy, approved June 4, 2021, and as Ozempic, approved December 5, 2017 ¹¹. Cagrilintide is in no approved product, and CagriSema's own trial record says "CagriSema is not yet being prescribed by doctors" ², ¹². Novo Nordisk wrote in December 2025 that "CagriSema is not approved in the US or EU" ¹. Outside a clinical trial, no source opened names a setting in which the combination is given ², ¹².

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How does CagriSema work?

The two drugs act on two different hormone systems. Semaglutide mimics GLP-1, a gut hormone that stimulates insulin release after a meal, slows stomach emptying and increases satiety through the brain's hypothalamus ¹³. Cagrilintide is an amylin receptor agonist, built to act at amylin's own receptors ⁶. In the words of the REIMAGINE 2 investigators, the two have "complementary effects on glycaemic control and bodyweight" ⁶.

Whether the pair produces more weight loss than either drug alone has been studied in people, not only proposed. In a 32-week randomized phase 2 trial of 92 adults with type 2 diabetes, weight fell 15.6% in the 31 on the combination ¹⁴. Semaglutide alone brought 5.1% in its 31 participants, and cagrilintide alone 8.1% in its 30 ¹⁴.

What does the research show?

Studied in people: REDEFINE 1, a 68-week phase 3 trial, randomized, double-blind, with placebo and active comparators, 3,417 adults ⁴. Entry required no diabetes and a body mass index of at least 30, or at least 27 with one or more obesity-related complications ⁴. The 2,108 participants on CagriSema lost an estimated 20.4% of body weight; the 705 on placebo lost 3.0% ⁴. The difference was 17.3 percentage points, with a 95% confidence interval of 16.6 to 18.1 ⁴. More of the CagriSema group than the placebo group reached losses of 5%, 20%, 25% and 30% or more ⁴.

Two smaller arms, 302 participants each, received semaglutide alone or cagrilintide alone ⁴. A secondary, post hoc analysis of the same trial reports the four arms on a different measure, assuming everyone stayed on treatment ¹⁵. On that measure, weight fell 22.7% with CagriSema, 16.1% with semaglutide alone, 11.8% with cagrilintide alone and 2.3% with placebo ¹⁵. Among participants who completed treatment, 30.3% of the CagriSema group reached both a body mass index under 27 and a waist-to-height ratio under 0.53 at week 68 ¹⁵. The completers' figures were 19.1% on semaglutide alone, 9.0% on cagrilintide alone and 3.3% on placebo ¹⁵.

Studied in people: REDEFINE 2, a 68-week phase 3 trial, randomized, double-blind and placebo-controlled, 1,206 adults with type 2 diabetes ⁵. Entry required a body mass index of 27 or more and an HbA1c, the three-month blood sugar measure, of 7 to 10% ⁵. The 904 on CagriSema lost an estimated 13.7% of body weight; the 302 on placebo lost 3.4% ⁵. The difference was 10.4 percentage points, with a 95% confidence interval of 9.5 to 11.2 ⁵. An HbA1c of 6.5% or less was recorded in 73.5% of the CagriSema group, against 15.9% on placebo ⁵.

Studied in people, against semaglutide alone: REIMAGINE 2, a randomized, double-blind phase 3 trial, 2,713 adults with type 2 diabetes on metformin, 68 weeks ⁶. By the efficacy estimand, HbA1c fell 1.91 percentage points in the 603 on CagriSema against 1.75 in the 605 on semaglutide alone ⁶. The difference was 0.16 points, with a 95% confidence interval of 0.05 to 0.27 ⁶. Novo Nordisk reports weight loss in that trial of 14.2% with CagriSema against 10.2% with semaglutide alone, "if all people adhered to treatment"; those are the company's figures ¹⁰.

A head-to-head trial against tirzepatide, REDEFINE 4, randomized 809 adults with obesity and completed its main period in December 2025 ¹². On February 23, 2026, Novo Nordisk announced that the trial "did not meet the primary endpoint of showing non-inferiority on weight loss compared to tirzepatide" at 84 weeks ¹⁶. By the company's figures, if all people adhered to treatment, weight fell 23.0% with CagriSema against 25.5% with tirzepatide, in an open-label trial ¹⁶. No results paper for it was found on PubMed as of November 9, 2026.

The published results above stop at 68 weeks ⁴, ⁵, ⁶. The cardiovascular outcomes trial REDEFINE 3, 7,101 adults with established heart or blood-vessel disease, is due to complete in 2027 ¹⁷.

What are the side effects?

In REDEFINE 1, gastrointestinal adverse events affected 79.6% of the CagriSema group and 39.9% of the placebo group ⁴. They included nausea, vomiting, diarrhea, constipation or abdominal pain, and were "mainly transient and mild-to-moderate in severity" ⁴. Novo Nordisk gives the breakdown as nausea in 55% against 12.6%, constipation in 30.7% against 11.6% and vomiting in 26.1% against 4.1% ¹. The company reports that 5.9% of the CagriSema group stopped for adverse events, against 3.5% on placebo ¹. In REDEFINE 2, the gastrointestinal figures were 72.5% against 34.4%, and the company's discontinuation figures 8.4% against 3% ⁵, ¹.

Against semaglutide alone, the combination carried somewhat more adverse events. In REIMAGINE 2, 86.9% of the 603 on CagriSema reported an adverse event, against 81.2% of the 605 on semaglutide alone ⁶. The figure on placebo was 70.5% of 149, and gastrointestinal disorders were the most common events in the active treatment groups ⁶.

In the 92-person phase 2 trial, adverse events were reported by 68% on the combination, 71% on semaglutide alone and 80% on cagrilintide alone ¹⁴. There was no level 2 or 3 low blood sugar, in the trial's grading, and no participant died ¹⁴. The REIMAGINE 2 authors call the safety profile "consistent with the GLP-1 receptor agonist class and previous safety data for cagrilintide" ⁶.

CagriSema has no FDA label, because no product is approved, but semaglutide has one ². Wegovy's label carries a boxed warning: in rodents, semaglutide causes thyroid C-cell tumors, and "It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans" ⁷. The label contraindicates Wegovy in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 ⁷. It warns of pancreatitis, gallbladder disease, acute kidney injury from fluid loss, low blood sugar when used with insulin, and severe gastrointestinal reactions ⁷. No label exists for CagriSema; whether those warnings apply to it is not stated in any source opened ².

In sport

CagriSema, cagrilintide and semaglutide are not named on WADA's 2026 Prohibited List ¹⁸. WADA is short for the World Anti-Doping Agency.

Its section S0 reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁸. Of the regulators, only FDA's records were read for CagriSema, and Novo Nordisk said in December 2025 that it "is not approved in the US or EU" ², ¹.

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JumpstartMD does not prescribe CagriSema. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 9, 2026.

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