Long-acting amylin analogue
Investigational weekly injectable mimicking the satiety hormone amylin (Novo Nordisk), developed mainly as 'CagriSema' with semaglutide.
| Class / type | Long-acting amylin analogue |
|---|---|
| Category | Metabolic & Weight |
| Status (Jul 2026) | Investigational |
Cagrilintide is an investigational once-weekly injectable that mimics amylin, a satiety hormone released alongside insulin. Its main development path is in combination with semaglutide as 'CagriSema,' pairing two different appetite mechanisms.
It is not approved as a standalone product; anything sold now outside trials is unregulated research material.
As a long-acting amylin (and calcitonin-receptor) agonist, it promotes fullness, slows gastric emptying and reduces food intake. Because this pathway differs from GLP-1, combining it with semaglutide is thought to be additive for appetite control.
In the Phase 3 REDEFINE 1 trial, CagriSema achieved about 20% average weight loss at 68 weeks. Cagrilintide alone has shown meaningful weight loss in earlier studies, but the pivotal program centers on the combination. Novo Nordisk filed CagriSema with the FDA in December 2025.
A novel, non-GLP-1 mechanism that appears additive when combined with semaglutide, and a potential option for people who plateau on GLP-1 drugs alone.
Trial weight-loss numbers for the combination are competitive with the leading agents.
GI effects (nausea, vomiting) typical of appetite-suppressing drugs; standalone long-term safety data are limited, and it is not approved.
Some analysts viewed certain trial readouts as below peak expectations.
Cagrilintide is being developed chiefly as the CagriSema combination rather than a solo product; there is no approved standalone version or sanctioned human dose.
Interest centers on the additive amylin+GLP-1 'next-gen' combination approach.
NOT FDA-approved. CagriSema NDA filed Dec 2025; FDA review during 2026. Standalone material is research-use-only.