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Tesofensine

A neurotransmitter reuptake inhibitor showing significant weight loss in Phase II and III trials.

Medications & hormones

Research records

Historical source snapshot. Not freshly verified, not a recommendation. Study findings, community accounts and app defaults are not interchangeable.

Publication suitability · 2026-10-15: Historical reference only; not a clinical verification. Clinical, regulatory, efficacy, safety and dose claims are not independently established by this review.

Tesofensine

A neurotransmitter reuptake inhibitor showing significant weight loss in Phase II and III trials.

Evidence category: Clinical study. This describes the source category, not approval or certainty.

Regulatory statement in source: Not approved in the United States or other major markets.

Tesofensine is an inhibitor of presynaptic serotonin, noradrenaline, and dopamine reuptake, acting as an appetite suppressant with effects on fat oxidation and energy expenditure. In Phase II trials, tesofensine produced mean weight loss of 4.5-10.6% at 24 weeks depending on dose, with placebo-subtracted weight loss of 4.5-10.6 kg. Phase III trials confirmed compelling efficacy and favorable safety profile. The most frequently reported adverse effects were gastrointestinal, similar to other weight-loss medications. Tesofensine was not approved in the United States but development continued in other contexts. Results suggest weight loss approximately twice that of some existing approved medications.

Benefits reported in the imported source

  • Demonstrated significant weight loss in Phase II and III randomized trials
  • Safety profile favorable compared to placebo

Risks and limits

  • Gastrointestinal adverse events most common, similar to other weight-loss medications
  • Not approved in United States
  • Long-term safety and efficacy beyond trials not established

Source bottom line: Tesofensine produced substantial weight loss in clinical trials but was not approved in major markets and development appears to have stalled.

Uncertainty: Reference information only. Not medical advice.

Study protocols — reports, not instructions

203 obese patients in Phase II trial (TIPO-1)

Reported regimen
Tesofensine once-daily oral doses combined with diet
Duration
24 weeks
Reported outcome
Mean weight loss 4.5-10.6% depending on dose; placebo-subtracted loss 4.5-10.6 kg
Source
Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial (availability check 2026-10-15: source not retrieved; HTTP 403)
Claim provenance

evidence.json#/catalog:medication:tesofensine/protocols/0

Community and practice descriptions

Accounts of a practice are not evidence of safety or effectiveness. Words such as “standard”, “safe” or “recommended” describe the source account, not verified consensus or this wiki’s advice. Commercial and self-published citations are retained for traceability, not vendor endorsement or independent clinical corroboration.

Historical research outcome: no-verified-description · 2026-10-06

No suitable community description was independently verified in these checks. The entry remains empty; this does not establish that no practice exists elsewhere.

Pharmacokinetic context

Historical half-life estimate: 234 hours. Lehr et al. 2007, Br J Clin Pharmacol, PMID 17324246 — human PK study; active metabolite M1 half-life is even longer, about 374 hours Population/route context and estimates may differ. This is not a schedule or a verified human dosing rule.

Source references

Snapshot provenance

Source ID: catalog:medication:tesofensine. Commit: adc7684614f9439b41d91a3312b62e7982c7e20e. Review state: historical-not-reverified. Authored links are retained separately from the canonical evidence links in the public data. App templates/defaults and rejected drafts are archived, not deployed.

Related entries and components

None listed.