K., Kang, Y., & Merlin, D
Cagrilintide (CAG) Amylin-Pathway Research Overview Cagrilintide is a long-acting, research-grade analog of human amylin, engineered to activate amylin and calcitonin-family receptors while resisting aggregation and enzymatic breakdown
FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes
The dedicated cardiovascular trial did not find excess major events and reported lower all-cause mortality, but resting heart rate remains a titration marker rather than a one-time measurement. How to Titrate, and the Cost of Going Too Fast The final dose shapes the endpoint, but escalation speed is the largest modifiable driver of side effects