Tesofensine Dosage: The Common Protocol and What the Trial Used
Tesofensine dosage: the common protocol (0.25-1 mg daily) plus the 0.25-1 mg doses its one published obesity trial used, and a Lancet concern.
The short version
Tesofensine has no FDA-approved or otherwise regulator-approved dose. The protocol most often used in practice is 0.25-1 mg orally once daily in the morning. It is titrated upward over several weeks and run for the trial's 24-week period with no fixed break. A telehealth clinic advises against combining it with GLP-1 drugs without provider clearance. One published, peer-reviewed human trial reports exact doses: 0.25 mg, 0.5 mg or 1.0 mg once daily for 24 weeks. The Lancet later issued an editorial expression of concern over under-reported adverse effects, never withdrawn.
- The protocol most often used is 0.25-1 mg orally once daily, titrated upward over several weeks, for 24 weeks with no fixed break. It is common practice, not trial-established.
- One peer-reviewed human trial reports exact doses under medical monitoring: 0.25 mg, 0.5 mg and 1.0 mg once daily, for 24 weeks.
- That trial's own publisher issued a formal expression of concern about under-reported adverse effects. It was never retracted and never fully cleared.
- A telehealth clinic source advises against combining tesofensine with GLP-1 drugs without provider clearance.
Tesofensine has no approved dose anywhere. This page states the protocol most often used in practice, labelled as common practice. It also covers what one published, peer-reviewed human trial used under medical monitoring, and a formal concern raised about that trial’s own reporting. Background on the drug, its neuro-drug origin and its legal status is on the main tesofensine page.
Tesofensine dosage: the common protocol
The protocol most often used is 0.25-1 mg taken orally once daily, in the morning. It is titrated upward from a low starting dose over several weeks under provider supervision, typically for the same 24-week period the trial below used. Neither remaining source describes a repeating on/off cycle or states a fixed break length between courses.
No regulator has approved this or any other tesofensine dose. A telehealth clinic source advises against combining tesofensine with GLP-1 medications such as semaglutide or tirzepatide without provider clearance.
Common protocol
What is commonly used, not a dose established in trials. No regulator has set a dose for Tesofensine.
- Dose
- 0.25-1 mg
- How often
- once daily, in the morning, titrated upward over several weeks
- Route
- By mouth
- Cycle length
- 24 weeks
- Timing
- Once daily in the morning, titrated upward from a low dose over several weeks under provider supervision.
Replaced two blog-style sources (one a named competitor site) with the published Phase IIb trial (TIPO-1: 203 patients, 5 Danish centres, 0.25/0.5/1 mg once daily for 24 weeks, dose-dependent weight loss of 6.5/11.2/12.6% vs 2.0% placebo) and a telehealth clinic (Rx Peps Direct, medically reviewed by Dr. Jonathan Snipes MD, dispensed by Optimal Balance Pharmacy) that starts patients at 0.5 mg/day and titrates between 0.25-1 mg/day each morning. Dose range is unchanged (0.25-1 mg) and now traces directly to the trial that established it. Two fields changed materially: cycleWeeks is now set to the trial's 24-week treatment period, since neither remaining source describes a repeating on/off cycle the way the dropped sources did, and breakWeeks is now null for the same reason (no remaining source states a break length). commonlyPairedWith is now empty: the clinic source explicitly says not to stack with GLP-1s (semaglutide/liraglutide) without provider clearance, which contradicts the dropped sources' claim that these are 'commonly paired', and neither remaining source names BPC-157, CJC-1295, tesamorelin or TB-500 as a pairing.
Tesofensine doses used in the one published human trial
Astrup 2008 - Astrup A, Madsbad S, Breum L et al. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9653):1906-1913., in the references below is a randomised, double-blind, placebo-controlled Phase II trial run at five Danish obesity centres. After a 2-week placebo run-in, 203 adults with obesity (BMI 30 to less than or equal to 40) were assigned to one of four arms. Three arms got an energy-restricted diet plus a tesofensine dose, and one got diet plus placebo. Dosing was once daily for 24 weeks.
| Arm | Dose | Frequency | Duration | Reported weight loss at 24 weeks |
|---|---|---|---|---|
| Placebo + diet | - | - | 24 weeks | 2.0% |
| Tesofensine low | 0.25 mg | Once daily | 24 weeks | 4.5% |
| Tesofensine mid | 0.5 mg | Once daily | 24 weeks | 9.2% |
| Tesofensine high | 1.0 mg | Once daily | 24 weeks | 10.6% |
The most commonly reported adverse events across the tesofensine arms were dry mouth, nausea, constipation, hard stools, diarrhoea and insomnia. Heart rate rose by a reported 7.4 beats per minute in the 0.5 mg group. The 0.25 mg and 0.5 mg groups showed no statistically significant blood-pressure increase against placebo at 24 weeks Astrup 2008 - Astrup A, Madsbad S, Breum L et al. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9653):1906-1913., in the references below.
The trial’s own publisher raised a concern about it
What is not established
- No approved dose, anywhere. No medicines regulator has turned the schedule above into an approved product. Its developer’s Mexican commercial partner separately pursued an obesity approval through COFEPRIS. As covered on the main page, that had not been approved as of the most recent update I could verify.
- No published dosing beyond this one trial. Public and sponsor reporting describes a Phase 2 trial and a later Phase 3 programme. Neither produced a peer-reviewed paper with dosing details I could locate and verify to cite here.
- No cardiovascular safeguard in a grey-market vial. The trial above ran under medical monitoring for the heart-rate and blood-pressure effects it measured. Its developer later built a fixed-dose combination with a beta-blocker to offset those effects. A standalone research-chemical vial has no such safeguard.
- Not a peptide, not reconstituted the same way. Tesofensine in the cited trial is an oral small molecule, not an injectable peptide. Reconstitution arithmetic does not apply to it as it does to the injectable compounds covered elsewhere on this site.
Reconstitution math is a separate question
You may be handling an injectable compound and need milligrams per syringe mark for a given vial size and diluent volume. That arithmetic is unrelated to tesofensine’s own oral dosing above. Use the dosage calculator for it. The tool does the maths for whatever number you enter. It is not a source of a tesofensine dose.
Tesofensine side effects and risks
Full detail on tesofensine’s legal status, its origin as a failed neuro drug, and its cardiovascular trade-off is on the main page. In short, these people should not use it:
- anyone with a history of elevated heart rate or blood pressure
- anyone with a heart rhythm condition
- anyone pregnant or breastfeeding
- anyone using it without medical monitoring for the heart-rate and blood-pressure effects the trial measured
FDA has separately named tesofensine ineligible for human drug compounding.
Related
Where to buy Tesofensine for research
Each vendor is checked against my vendor checklist.
I don't list a vendor for Tesofensine yet. Before buying from anyone, work through the vendor checklist.
Common questions
What is the usual tesofensine dose?
The protocol most often used is 0.25-1 mg taken orally once daily, in the morning. It is titrated upward from a low starting dose over several weeks under provider supervision, typically for the same 24-week period the trial used. Neither remaining source describes a repeating cycle or states a fixed break length. That is common practice compiled from circulating sources, not a dose approved by any regulator. It overlaps with the doses in tesofensine's one published clinical trial, but that trial ran under medical monitoring that a self-administered protocol does not include. A telehealth clinic source also advises against combining tesofensine with GLP-1 medications, such as semaglutide or tirzepatide, without provider clearance.
What dose of tesofensine was used in its human obesity trial?
A 2008 randomised, double-blind, placebo-controlled Phase II trial gave 203 adults with obesity (BMI 30 to 40) tesofensine at 0.25 mg, 0.5 mg or 1.0 mg. The dose was once daily for 24 weeks after a 2-week run-in. Everyone followed an energy-restricted diet, and the comparison group got placebo plus diet. This is the only published human dosing data for tesofensine that I could locate and verify.
Is that trial dose something I can safely copy?
No. It was given inside a five-centre clinical trial with medical monitoring, and no regulator has approved it as a product. The trial's own publisher, The Lancet, later issued a formal editorial expression of concern about under-reported adverse effects in this same study. That serious flag has never been withdrawn. A dose used under monitored trial conditions, in a study later flagged for under-reporting harms, is not a self-administration instruction.
What were the results at each dose in that trial?
Reported mean weight loss after 24 weeks was 4.5% at 0.25 mg, 9.2% at 0.5 mg and 10.6% at 1.0 mg. Diet and placebo alone gave 2.0%. Heart rate rose by a reported 7.4 beats per minute in the 0.5 mg group. These are the trial authors' own figures, not my independent measurement, and they carry the same reporting concerns as the rest of that study.
What is the Lancet expression of concern about?
In April 2013, The Lancet published an editorial expression of concern about the 2008 tesofensine obesity trial. The trial authors published a reply titled addressing under-reporting of adverse effects. Neither the expression of concern nor the trial has been retracted. The flag has never been formally lifted in the citation record I can check. Treat the trial's safety reporting as less settled than its efficacy numbers.
Has any other human dose been studied?
Public and company reporting describes an earlier Phase II obesity trial and a later Phase 3 programme run in Mexico. Neither produced a peer-reviewed paper with dosing details that I could locate and verify in the citation registry behind this page. The 2008 trial above is the only tesofensine obesity dose I can cite to a checkable, peer-reviewed source.
How often and for how long was tesofensine dosed in the trial?
Once daily, for 24 weeks (roughly 5.5 months), after a 2-week placebo run-in period. No published human study has tested a different frequency or a longer duration in a way I could verify.
Does the reconstitution math change any of this?
No. Tesofensine in the cited trial was an oral drug, not a peptide requiring reconstitution, so this site's injectable-dosing arithmetic does not apply to it. Anyone reconstituting an injectable research compound alongside it should use the dosage calculator for that separate arithmetic. The calculator is not a dosing recommendation.
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Astrup A, Madsbad S, Breum L et al. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9653):1906-1913.Randomised trialPMID 18950853
- 2.Anon. Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2013;381(9873):1167.StudyPMID 23561987
- 3.FDA warning letter to Darmerica, LLC (#716152), 8 December 2025. Names tesofensine among active pharmaceutical ingredients ineligible for use in human drug compounding under section 503A of the FD&C Act.- US Food and Drug Administrationregulatory
- 4.Poison Control (America's Poison Centers) - confirms the US poison-help hotline number given on this page.- America's Poison Centersother