#5Metabolic & Frontier
Cagrilintide + semaglutide blend
unapproved co-formulation/mixture of an investigational amylin analogue and semaglutide
Evidence: human RCTReviewed 2026-07-25
Investigated uses
- Obesity and weight management with sponsor-manufactured CagriSema.
Mechanism and hypotheses
- Sponsor CagriSema combines cagrilintide and semaglutide to engage amylin-family and GLP-1 receptors.
- Hypothesized: Pharmacologic complementarity observed with the sponsor product cannot establish equivalence, stability or dose uniformity of a vendor-mixed vial.
Human evidence
- REDEFINE 1 tested sponsor-manufactured cagrilintide–semaglutide in a phase 3 randomized trial and found greater weight loss than placebo. Limitations: The studied co-formulation and delivery system are not chemically or pharmaceutically interchangeable with a vendor blend.
Safety highlights
- Unknown or insufficiently characterized for the exact catalog product.
- Identity, purity, sterility, endotoxin, aggregation, immunogenicity, concentration and route-specific risks are not adequately characterized.
Regulatory context
No FDA approval was identified for a vendor-mixed cagrilintide/semaglutide vial; sponsor CagriSema trial evidence is formulation-specific.
Sources used for this entry
- PubMed search: Cagrilintide + semaglutide blend — PubMed
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — U.S. Food and Drug Administration
- Drugs@FDA database — U.S. Food and Drug Administration
- EMA medicines search — European Medicines Agency
- NCT05567796: REDEFINE 1 CagriSema — ClinicalTrials.gov
- Cagrilintide-Semaglutide in adults with overweight or obesity — New England Journal of Medicine / PubMed