Cagrilintide Investigational

Metabolic

Cagrilintide

An investigational long-acting amylin analog

Investigational · not approved · not available for sale or prescription
Why it’s not available
Stylised model of the real sequence

Overview.

Cagrilintide is an investigational drug and is not approved anywhere. It is Novo Nordisk's long-acting amylin-receptor agonist, engineered like semaglutide with a fatty-acid tail that extends its half-life. It is being developed alone and, more prominently, in a fixed-dose combination with semaglutide called CagriSema for weight management. Novo submitted CagriSema to FDA in December 2025 and expects FDA review in 2026.

Also known as AM833 · NNC0174-0833

The molecule, decoded.

Sequence

[C20 diacid-gammaGlu]-K-C-N-T-A-T-C-A-T-Q-R-L-A-E-F-L-R-H-S-S-N-N-F-G-P-I-L-P-P-T-N-V-G-S-N-T-P-NH2 (37 aa; lipid on the N-terminal alpha-amine of Lys1; disulfide Cys2-Cys7)

Length
37 residues
Molecular weight
4,409 g/mol
Formula
C194H312N54O59S2
CAS number
1415456-99-3
Half-life
159-195 hours (~7-8 days)
Routes studied
subcutaneous injection
Modifications
Human-amylin backbone with 6 substitutions per the WHO INN name - Asn14Glu and Val17Arg (salt-bridge stabilization, reduced deamidation), Ala25Pro/Ser28Pro/Ser29Pro (as in rat amylin, reduces beta-sheet/fibril formation), and Tyr37Pro at the C-terminus; C-terminal amide retained; the N-terminal alpha-amino group of Lys1 is acylated with a C20 (19-carboxynonadecanoyl) fatty diacid via a single gamma-Glu linker (no AEEA spacers) for albumin binding and extended half-life; intramolecular Cys2-Cys7 disulfide as in native amylin

How it works.

Cagrilintide is a stabilized, lipidated analog of human amylin that activates amylin/calcitonin receptor complexes in the area postrema and hypothalamus, enhancing satiety, slowing gastric emptying, and suppressing glucagon secretion. Combined with a GLP-1 agonist (semaglutide), it produces additive appetite suppression through complementary satiety pathways.

Evidence · Phase 3 clinical trials

What the research shows

phase 3 RCT2025

Cagrilintide co-administered with semaglutide (CagriSema) produced 20.4% mean weight loss (22.7% with full adherence) vs 3.0% with placebo at 68 weeks; about 40% of participants lost at least 25% of body weight.

adults with overweight/obesity, REDEFINE 1

Source
phase 3 RCT2025

In REDEFINE 2 (adults with type 2 diabetes), CagriSema produced 13.7% mean weight loss (15.7% with full adherence) vs 3.4% with placebo.

adults with T2D and overweight/obesity

phase 2 RCT2021

In a phase 2 dose-finding trial of cagrilintide alone, weight loss at 26 weeks ranged from 6% to 10.8% across doses, vs 9.0% with liraglutide and 3% with placebo.

706 adults with overweight/obesity

Source
phase 2 RCT2023

In a 32-week phase 2 trial in 92 adults with type 2 diabetes, CagriSema lowered HbA1c by 2.2 points vs 1.8 with semaglutide alone (difference not statistically significant, p=0.075) and reduced body weight by 15.6% vs 5.1% with semaglutide (p<0.0001).

adults with T2D, phase 2

Source
regulatory2025

Novo Nordisk submitted a new drug application for CagriSema (cagrilintide plus semaglutide) for weight management on Dec 18, 2025, based on REDEFINE 1 and REDEFINE 2; Novo said FDA is expected to review it in 2026. Not approved anywhere as of Sep 2026.

n/a - regulatory filing

What to know first.

Based on: published clinical trials.

Reported side effects

  • nausea
  • vomiting
  • diarrhea
  • constipation
  • injection-site reactions

Cautions

  • GI adverse events affected 79.6% of CagriSema-treated vs 39.9% placebo participants in REDEFINE 1, mainly mild-to-moderate and transient
  • amylin-class theoretical risk of hypoglycemia if combined with insulin/sulfonylureas (by analogy to pramlintide)
  • not FDA-approved, so it has no FDA label

Checked 2026-09

Where it stands.

Investigational · not approved · not available for sale or prescription. Cagrilintide is an investigational drug still in clinical trials. It is not approved and not available for sale or prescription. The legitimate way to access it is by enrolling in a clinical trial. Find trials on ClinicalTrials.gov
FDA
investigational as standalone cagrilintide; combination product CagriSema (cagrilintide + semaglutide) NDA submitted to FDA Dec 18, 2025, with FDA review expected in 2026 per Novo Nordisk - not approved anywhere as of Sep 2026
Compounding
Not eligible for compounding: cagrilintide is not a component of any FDA-approved drug and is in no 503A category, and FDA states it cannot be used in compounding under federal law.
Sport (WADA)
Prohibited at all times (in and out of competition) under S0 Non-Approved Substances: cagrilintide is not named on the WADA 2026 Prohibited List, but it has no approval from any regulatory authority for human use (CagriSema still under FDA review as of Sep 2026), so S0 applies. The 2027 List (published 21 Sep 2026) adds 'peptides' to the S0 examples.
References (3)
  1. PubMed · PMID 40544433
  2. PubMed · PMID 34798060
  3. thelancet.com · abstract

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