Tesofensine Reference

Plain English

What it is

Tesofensine is an experimental weight-loss drug, not an approved one. It is a small-molecule medicine (not truly a peptide) that adjusts brain chemicals linked to appetite. It was first studied for Parkinson's and Alzheimer's disease and later tested for obesity. It is not approved by the FDA.

What people use it for

In research, it has been tested as a way to help people with obesity lose weight. Early human trials reported large amounts of weight loss, and those headlines are what drive interest in it.

What the science shows

It has gone through human trials, including a mid-stage (Phase 2) obesity study that showed notable weight loss, followed by a partner-run later-stage (Phase 3) program. It received a favorable opinion from Mexico's drug regulator in 2023 and is sold there, but it is still investigational and not FDA-approved in the United States.

The catch

In studies it raised blood pressure and heart rate, a heart-related safety concern that has slowed its progress. Because it is not FDA-approved, its quality and safety are not government-checked. A separate combination called Tesomet pairs it with a heart medicine (metoprolol) to try to offset those heart effects.

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