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

What is cagrilintide?

Cagrilintide is an investigational peptide drug developed by Novo Nordisk ³, ⁴. It is a long-acting analog of amylin, a hormone made in the pancreas that induces satiety, the sense of having eaten enough ¹. An analog is a modified copy of the natural hormone. Cagrilintide is long-acting, and the trials give it once a week ¹, ³.

It is studied on its own and as one half of CagriSema, a fixed-dose combination with semaglutide ⁴. Semaglutide is a GLP-1 receptor agonist that FDA has approved for type 2 diabetes and for obesity ⁹.

Is cagrilintide FDA-approved?

Cagrilintide is not FDA-approved: Drugs@FDA lists no approved cagrilintide product as of November 9, 2026 ². It is an investigational drug in phase 3 trials; its trial record, updated August 2026, calls it "a new investigational medicine" and says "Doctors may not yet prescribe cagrilintide" ³. The combination with semaglutide is further along.

Novo Nordisk announced on December 18, 2025 the submission of a New Drug Application for CagriSema to FDA ⁴. The application is for weight management in adults with obesity, or with overweight and a weight-related condition ⁴. On September 30, 2026, the company still described CagriSema as investigational and said "A decision is expected in Q4 2026" ⁵. Drugs@FDA lists no product containing cagrilintide as of November 9, 2026, so no approval of CagriSema is recorded there ².

For you, this means there is no approved cagrilintide product for a clinician to prescribe ². FDA's list of bulk substances nominated for pharmacy compounding under section 503A, updated May 14, 2026, does not name cagrilintide either ¹⁰. Outside a clinical trial, there is no approved product and no compounding nomination to point to ², ¹⁰.

See the FDA status of every peptide, updated weekly.

How does cagrilintide work?

Amylin is a hormone the pancreas releases, and the phase 2 trial's authors describe it as a hormone "that induces satiety" ¹. Cagrilintide is an amylin receptor agonist: a molecule that switches on the receptors natural amylin acts on ¹¹. GLP-1 receptor agonists such as semaglutide work through a different gut-hormone pathway and are approved to treat type 2 diabetes and obesity ⁹. The REIMAGINE 2 investigators describe the two drugs as having "complementary effects on glycaemic control and bodyweight," which is the reason for pairing them ¹¹.

How much of CagriSema's effect comes from cagrilintide has been studied in people. In a 32-week trial that compared all three, adults with type 2 diabetes lost less weight on cagrilintide alone than on the combination ⁸. They lost more than on semaglutide alone ⁸.

What does the research show?

Studied in people: a randomized, double-blind, placebo-controlled and active-controlled phase 2 trial, 26 weeks ¹. It enrolled adults without diabetes with a body mass index of 30 or more, or 27 or more with high blood pressure or abnormal blood fats ¹. It randomized 706 adults to cagrilintide, 101 to placebo and 99 to liraglutide ¹. In those who stayed on treatment, mean weight fell by 6.0% to 10.8% across the cagrilintide groups, against 3.0% with placebo ¹. By the same measure the highest cagrilintide group lost 10.8%, against 9.0% with daily liraglutide, a GLP-1 drug FDA has approved for obesity ¹, ⁹.

Studied in people: a randomized, double-blind phase 2 trial, 92 adults with type 2 diabetes and a body mass index of 27 or more, 32 weeks ⁸. Weight fell 8.1% in the 30 adults on cagrilintide alone, 5.1% in the 31 on semaglutide alone and 15.6% in the 31 on the two together ⁸. Blood sugar, measured as HbA1c, fell 0.9 percentage points with cagrilintide alone, against 1.8 with semaglutide and 2.2 with the combination ⁸.

Studied in people: REDEFINE 1, a randomized, double-blind, placebo-controlled and active-controlled phase 3 trial, 3,417 adults, 68 weeks ⁶. It enrolled adults without diabetes with a body mass index of 30 or more, or 27 or more with at least one obesity-related complication ⁶. Mean weight fell 20.4% in the 2,108 participants on CagriSema against 3.0% in the 705 on placebo ⁶. Those figures count everyone randomized, whether or not they stayed on treatment ⁶.

The trial also randomized 302 participants to cagrilintide alone and 302 to semaglutide alone ⁶. A secondary analysis of REDEFINE 1 reports all four arms at 68 weeks, estimated as if no one had stopped treatment ¹². Weight fell 22.7% with CagriSema, 16.1% with semaglutide alone, 11.8% with cagrilintide alone and 2.3% with placebo ¹².

Studied in people: REDEFINE 2, a randomized, double-blind, placebo-controlled phase 3 trial, 1,206 adults with type 2 diabetes and a body mass index of 27 or more, 68 weeks ⁷. Mean weight fell 13.7% in the 904 participants on CagriSema against 3.4% in the 302 on placebo ⁷. An HbA1c of 6.5% or less was reached by 73.5% of the CagriSema group, against 15.9% on placebo ⁷.

None of these trials reports outcomes beyond 68 weeks ¹, ⁶, ⁷, ⁸. As of November 9, 2026, no phase 3 trial of cagrilintide on its own has reported results. One, RENEW 1, enrolls about 300 adults without diabetes with a body mass index of 30 or more, or 27 or more with a weight-related condition ³. It tests cagrilintide against placebo for 64 weeks and is due to finish in 2027 ³.

What are the side effects?

In the 26-week phase 2 trial, the most frequent adverse events were gastrointestinal, such as nausea, constipation and diarrhea, and reactions at the injection site ¹. Gastrointestinal events affected 41% to 63% of the cagrilintide groups against 32% on placebo, and nausea 20% to 47% against 18% ¹. Seventy-three participants, 10%, stopped treatment permanently, mostly because of adverse events, at similar rates across the groups ¹.

In the 92-person diabetes trial, adverse events were reported by 80% of the cagrilintide group, 71% of the semaglutide group and 68% of the combination group ⁸. Mild or moderate gastrointestinal adverse events were most common; no level 2 or 3 hypoglycemia and no fatal adverse events were reported ⁸. REIMAGINE 2 was a 68-week phase 3 trial in 2,713 people with type 2 diabetes ¹¹. There, 82.2% of the 152 participants on cagrilintide alone reported an adverse event, against 70.5% on placebo ¹¹. The authors call the combination's safety profile consistent with earlier cagrilintide data and with the GLP-1 receptor agonist class ¹¹.

With semaglutide, the gastrointestinal burden is higher. In REDEFINE 1, 79.6% of the CagriSema group had gastrointestinal adverse events against 39.9% on placebo ⁶. In REDEFINE 2 the figures were 72.5% against 34.4% ⁷. The authors of both trials call most of them transient and mild to moderate ⁶, ⁷. Novo Nordisk reports that 5.9% of the CagriSema group stopped treatment for adverse events in REDEFINE 1 against 3.5% on placebo, and 8.4% against 3% in REDEFINE 2 ⁴.

A heart-rhythm study of 105 healthy adults found no clinically relevant lengthening of the QT interval, a measure of the heart's electrical recovery between beats ¹³. It was run in healthy adults, not in people with obesity or diabetes ¹³.

In sport

Cagrilintide is not named on WADA's 2026 Prohibited List ¹⁴. WADA is 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 ... is prohibited at all times" ¹⁴. The list gives "drugs under pre-clinical or clinical development" as an example ¹⁴. Only FDA's approvals were checked for this page; no other regulator's were ².

What JumpstartMD offers

JumpstartMD does not prescribe cagrilintide. 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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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.