● TIER 3 — Information onlyGRADE A (combo) — unapprovedGLP-1 / incretins & amylin
Cagrilintide / CagriSema
Long-acting amylin analog. Research verification: Yes (TGA pending). 3 human study record(s) in the FitClinicMD studies database.
GOALS · Weight loss
FDA status
CagriSema filed with FDA Dec 2025; not approved as of Oct 2026 (secondary sources; confirm on Drugs@FDA).
Compounding (503A/503B)
Not compoundable.
DEA
Not controlled.
WADA (sport)
S0 Non-approved substances
Mechanism
Amylin/calcitonin receptor agonist, weekly.
Human evidence · 3
REDEFINE 1 (NEJM 2025): CagriSema vs components in obesity. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.
Phase 2 with semaglutide in T2D. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.
Phase 2 monotherapy dose-finding, n=706. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.
Reference only. This page summarizes publicly available regulatory and research information about Cagrilintide / CagriSema. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.