Compounds / Cagrilintide

Cagrilintide

Also known as: AM833, component of CagriSema

Phase 3 clinical (investigational) Not approved · investigational Category: GLP-1 and Metabolic

The compounds described in this library are research-use-labeled chemicals and are not FDA-approved for human use. This content is factual scientific reference drawn from published literature. It is not medical, dosing, or purchasing advice. VialReport does not sell, supply, or distribute any compound.

Short summary

An investigational long-acting amylin analogue developed by Novo Nordisk. It is not FDA-approved, and its development has focused on the combination product CagriSema rather than on cagrilintide as a standalone treatment.

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Origin and Development

Developed by Novo Nordisk as a long-acting analogue of amylin, a hormone co-secreted with insulin by pancreatic beta cells. Amylin signaling is a distinct pathway from the incretin system that GLP-1 agonists act on, which is the rationale for combining the two.

Mechanism as Understood in the Literature

Amylin receptor agonist. Amylin is associated with regulation of gastric emptying and satiety signaling, and is understood to act through a mechanism complementary to, rather than overlapping with, GLP-1.

Research Status

Phase 2 monotherapy data were published in The Lancet in 2021. Development has since concentrated on CagriSema, a fixed-dose combination of cagrilintide 2.4 mg with semaglutide 2.4 mg, studied in the REDEFINE program in obesity and the REIMAGINE program in type 2 diabetes, with Phase 3 data published in 2025. Novo Nordisk submitted a New Drug Application to the FDA for CagriSema in December 2025, with FDA review expected during 2026.

Regulatory status · investigational

Not approved by the FDA or any other regulator.

Cagrilintide is an investigational molecule with no approved product, no compounding pathway, and no USP/NF monograph.

Any material offered for sale outside a clinical trial is outside the sponsor's supply chain entirely.

Commonly Confused With

Distinct from GLP-1 receptor agonists, though frequently discussed alongside them and sold in the same channels. Also distinct from CagriSema, which is the combination product containing both cagrilintide and semaglutide. And distinct from zenagamtide (formerly amycretin), a separate Novo Nordisk molecule that combines GLP-1 and amylin activity in a single compound.

How This Compound Is Marketed

Vendor marketing for this compound typically references weight loss, frequently paired with semaglutide in vendor listings mirroring the CagriSema combination. VialReport does not evaluate or endorse these claims. See Research Status above for what the published literature actually establishes.

Analytical Profile

A modified, acylated peptide analogue of human amylin. As with retatrutide, there is no approved reference product outside the trial supply chain, so identity confirmation depends on a certified reference standard and mass spectrometry is the appropriate method.

Stability and Handling

No approved product exists, so no manufacturer-defined storage specification is available outside the clinical trial setting.

Key Literature

  1. 01 Lau DCW, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicenter, randomized, double-blind, placebo-controlled and active-controlled, dose-finding Phase 2 trial. Lancet. 2021;398:2160-2172.
  2. 02 Novo Nordisk. REDEFINE 1 Phase 3 results. 2025.
  3. 03 Novo Nordisk. NDA submission for CagriSema. December 18, 2025.

VialReport publishes factual reference information and independent test data. Nothing here is medical, dosing, or purchasing advice.

Published reports

Reports for Cagrilintide

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