Tesofensine dosage in published studies and labels

These are the doses used for Tesofensine in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources: November 7, 2026

Studied regimens and sources

Tesofensine has no approved dosage in the United States or the European Union. Human dosing comes from trials: the phase 2 TIPO-1 obesity trial compared 0.25, 0.5 and 1.0 mg taken by mouth once daily for 24 weeks alongside a calorie-restricted diet, and a later trial in hypothalamic obesity used 0.5 mg combined with 50 mg metoprolol.

Clinical Trial Evidence

Dosage evidence summary for Tesofensine
Human dosing established	Yes
Studied dose range	0.25–1.0 mg once daily in trials
Route	Oral
Frequency	Once daily
Duration studied	24 weeks in the published obesity trials
Evidence level	Clinical Trial Evidence
Last reviewed	2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Tesofensine, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
TIPO-1 phase 2 obesity trial (2008)Clinical trial · Phase 2 randomised double-blind placebo-controlled trial (NCT00394667)	Adults with obesity, BMI 30–40, on an energy-restricted diet (n=203)	0.25 mg (n=52), 0.5 mg (n=50) or 1.0 mg (n=49), or placebo	Oral	Once daily	24 weeks	Mean weight loss of 4.5%, 9.2% and 10.6% versus 2.0% on diet and placebo; heart rate rose by 7.4 beats per minute at 0.5 mg	Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008.
Tesofensine combined with metoprolol (Tesomet) — hypothalamic obesity (2022)Clinical trial · Randomised controlled trial of a fixed combination	Adults with hypothalamic obesity	0.5 mg tesofensine with 50 mg metoprolol, or placebo	Oral	Once daily	24 weeks	Body weight change	Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity. Eur J Endocrinol. 2022.

Where sources disagree

The largest published obesity trial is the 24-week phase 2 TIPO-1 study, whose authors said its efficacy and safety findings needed confirmation in phase 3 trials.
Tesofensine raises heart rate, which is why it was later tested combined with the beta-blocker metoprolol. Results from the combination do not describe tesofensine taken alone.
Tesofensine is a small-molecule monoamine reuptake inhibitor, not a peptide. It is listed here because it is discussed alongside research peptides for weight loss.