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Tesofensine

Tesofensine is an investigational monoamine-reuptake inhibitor with randomized oral weight-loss evidence and a material integrity caveat attached to its central trial report.

tier B · weight loss · Expression of Concern attached to the central TIPO-1 report

verdict

Tesofensine produced dose-related 24-week weight loss in TIPO-1 and in a Mexican regulator-registry summary. The first report has an Expression of Concern, the phase 3 summary is not a peer-reviewed full report, and no final Mexican or US authorization was verified.

the core tension

The weight-loss signal is direct enough for a Tier B page, but the central monotherapy report carries an integrity notice, phase 3 detail remains registry-only, and the regulatory record is not closed.

what it is

Tesofensine free substance, also called NS2330, and tesofensine citrate are separate mass and identity records. Tesomet is tesofensine plus metoprolol, while M1 or NS2360 is an active N-desmethyl metabolite rather than a synonym or market formulation.

what it does

The clinical program describes dopamine, norepinephrine, and serotonin reuptake inhibition. Human PET directly measured DAT occupancy after oral tesofensine, but it did not directly measure human NET or SERT occupancy or prove the full appetite mechanism.

origin

A February 2023 New Molecules Committee favorable opinion was not marketing authorization. On February 20, 2026, Medix revised and resubmitted its application, and sponsor reports still described review and approval as prospective.

does it work

TIPO-1 reported mean total weight losses of 4.5%, 9.2%, and 10.6% with 0.25, 0.5, and 1.0 mg oral tesofensine versus 2.0% with placebo over 24 weeks. A Mexican regulator registry reported a similar dose gradient, but its phase 3 result is regulator-registry evidence, not a peer-reviewed full report.

key facts

  • molecular formula: C17H23Cl2NO free substance; C23H31Cl2NO8 citrate salt
  • molecular weight: 328.3 g/mol free substance; 520.4 g/mol citrate salt
  • amino acids: n/a (small-molecule monoamine-reuptake inhibitor)
  • half-life: model-derived terminal values of about 234 h for parent and 374 h for M1 in the cited Alzheimer-disease population
  • type: tesofensine free substance with a distinct citrate salt and active M1 metabolite
  • CAS: 195875-84-4 free substance; 861205-83-6 citrate salt
  • 203 adults randomized in TIPO-1
  • 372 participants in the Mexican regulator-registry summary
  • 0 participants enrolled in withdrawn NCT05147415

frequently asked questions

What does the TIPO-1 Expression of Concern cover?

It covers adverse-event reporting, informed consent at one site, and blinding integrity. The paper is not marked retracted, but its safety account and trial conduct cannot be presented as settled.

Was the Mexican phase 3 study peer reviewed?

The Mexican phase 3 result is a regulator-registry summary, not a peer-reviewed full report. It cannot supply a complete safety table.

Does the favorable Mexican committee opinion mean the product is authorized?

No. A favorable opinion was not marketing authorization. On February 20, 2026 Medix revised and resubmitted the application, and final authorization was not independently verified in the dated regulator check.

What happened to NCT05147415?

NCT05147415 was withdrawn with n=0 and no results, so it adds no efficacy or safety evidence.

Does Tesomet prove tesofensine is cardiovascularly neutral?

No. Tesomet includes metoprolol and does not establish tesofensine-monotherapy cardiovascular safety. A separate registry study measured heart-rate increases with tesofensine alone.

related peptides

  • semaglutide: The tesofensine evidence cited on this page does not establish semaglutide's identity, approval, cardiovascular outcomes, or safety profile.

reptides grades the research record and cites the literature behind every call. research reference only; not medical advice.