For research and educational purposes only. Not medical advice.
Tesofensine Reference
Educational, not medical advice reference for Tesofensine: Fat Loss, Metabolic; regulatory status, evidence posture, source review, and schedule…
Reference summary
Phase 2 obesity trials reported substantial weight loss, and a partner-run (Medix) Phase 3 program was completed with a favorable Mexican regulatory (COFEPRIS) opinion in 2023. Standalone tesofensine carries a cardiovascular signal; the related Tesomet combination adds metoprolol. pepSmart displays tesofensine only as trial-context educational content, and it is not FDA-approved.
Regulatory and posture
- Categories
- Fat Loss, Metabolic
- Aliases
- NS2330, Triple monoamine reuptake inhibitor, Non-peptide small molecule
- Evidence posture
- human - Human Phase 2 obesity data exist and a partner-run Phase 3 was completed (favorable Mexican COFEPRIS opinion, 2023), but tesofensine remains investigational and is not FDA-approved. A cardiovascular signal shaped development; the related Tesomet program adds metoprolol.
- Regulatory status
- Investigational. Tesofensine is a non-peptide small-molecule monoamine reuptake inhibitor studied for weight loss in obesity, originally developed for Parkinson's and Alzheimer's. There is no FDA-approved tesofensine drug label. A Phase 3 program in tesofensine (run by partner Medix) was completed and received a favorable Mexican regulatory (COFEPRIS) opinion in 2023; Saniona's related Tesomet program pairs tesofensine with metoprolol to offset the cardiovascular signal.
- Content review status
- investigational verified