Tesofensine: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
📌TL;DR
- •3 dosing protocols documented
- •See reconstitution section
- •Storage: Room temperature, dry, dark; protect from heat and humidity (standard for oral small-molecule tablets / capsules in clinical use).
| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Phase 2 obesity dose (Astrup 2008): low | 0.25 mg | Once daily, oral | 24 weeks | Approximately 4.5% placebo-subtracted weight loss at 24 weeks; lowest side-effect burden of the three doses studied. PMID 18950853. |
| Phase 2 obesity dose (Astrup 2008): mid | 0.5 mg | Once daily, oral | 24 weeks | Approximately 9.2% placebo-subtracted weight loss at 24 weeks; intermediate side-effect burden. PMID 18950853. |
| Phase 2 obesity dose (Astrup 2008): high | 1.0 mg | Once daily, oral | 24 weeks | Approximately 10.6% placebo-subtracted, approximately 12.8% total body weight loss at 24 weeks; highest weight loss but also highest rates of dry mouth, insomnia, and heart-rate increase. PMID 18950853. |
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Dosing protocol timeline for Tesofensine
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🧊Storage Requirements
Room temperature, dry, dark; protect from heat and humidity (standard for oral small-molecule tablets / capsules in clinical use).
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Tesofensine Dosing: Phase 2 Trial Protocols#
Important Disclaimer#
This page documents tesofensine dose levels used in published clinical research. Tesofensine has not been approved for marketing by the FDA, EMA, or other major regulators. There is no approved indication and no approved dose. The information here exists for educational and research-context purposes and does not constitute medical advice. Any human use of tesofensine outside of a registered clinical trial is unauthorized.
Route and Administration#
Unlike peptide anti-obesity drugs (which require subcutaneous injection of a reconstituted lyophilized powder), tesofensine is taken orally:
- Route: Oral (tablet or capsule in clinical trials)
- Frequency: Once daily - enabled by a terminal half-life of approximately 220 hours1
- With or without food: Phase 2 trial dosing was once daily; specific food-effect data are limited in the public literature
- Onset of effect: Slow; clinically meaningful weight changes were observed over weeks to months, not days
- Steady state: Reached after approximately 4-6 weeks of daily dosing due to the long half-life
Research-Based Dosing (Phase 2 Obesity)#
The Astrup 2008 Phase 2 trial2 is the source of all human dose-response data shown below. Doses were administered once daily for 24 weeks on a background of hypocaloric diet.
| Dose | Mean placebo-subtracted weight loss (24 wk) | Mean total body weight reduction (1.0 mg only) | Notes |
|---|---|---|---|
| Placebo | - | - | Hypocaloric diet only |
| 0.25 mg | approximately 4.5% | - | Mildest side-effect burden |
| 0.5 mg | approximately 9.2% | - | Intermediate side-effect burden |
| 1.0 mg | approximately 10.6% | approximately 12.8% | Largest weight loss; highest rates of dry mouth, insomnia, heart-rate increase |
Tesomet: The Combination Product#
Tesomet is Saniona's fixed-dose combination of tesofensine plus the cardioselective beta-1 blocker metoprolol, intended to blunt the heart-rate increase observed with tesofensine monotherapy3. Exact tesofensine and metoprolol component dose-ratios depend on the specific Tesomet study and indication. Tesomet is being developed in:
- General obesity
- Hypothalamic obesity (rare endocrine condition with severe hyperphagia)
- Prader-Willi syndrome (genetic obesity syndrome with hyperphagia)
For current Tesomet dose-ranging information, refer to Saniona's ClinicalTrials.gov registrations and investor disclosures3. Peer-reviewed publication of the full Tesomet Phase 3 obesity dose schedule was not indexed in PubMed under a verifiable identifier as of June 2026.
Reconstitution#
Not applicable. Tesofensine is an oral small molecule. There is no reconstitution, no bacteriostatic water, no syringe, and no injection.
This is a major practical difference from the peptide anti-obesity drugs in this directory:
| Drug | Form | Preparation |
|---|---|---|
| Tesofensine | Oral tablet / capsule | None |
| Semaglutide | Pre-filled pen (clinical) / lyophilized vial (compounded) | None / reconstitute |
| Tirzepatide | Pre-filled vial or pen | None / reconstitute |
| Retatrutide | Investigational only | Reconstitute |
Storage Guidelines#
For oral tablet / capsule formulations under clinical trial use:
- Store at controlled room temperature (typically 20-25 degrees C / 68-77 degrees F)
- Keep dry and protected from heat and humidity
- Keep in original packaging until use
- No refrigeration required (in contrast to most peptide GLP-1 agonists)
Titration and Discontinuation Considerations#
Because of tesofensine's long terminal half-life (approximately 220 hours / approximately 9 days)1:
- Steady state is not reached for 4-6 weeks of daily dosing - early apparent efficacy may underestimate full effect
- Washout after discontinuation is similarly slow - residual pharmacological activity may persist for 2-4 weeks
- Trial protocols have used fixed daily dosing without aggressive titration; mood, sleep, and cardiovascular monitoring through the steady-state period is appropriate in a clinical research setting
References#
Related Reading#
- Tesofensine overview
- Tesofensine research studies
- Tesofensine side effects
- Tesofensine risks
- Semaglutide dosing
Footnotes#
-
Bello NT, Zahner MR. Tesofensine, a monoamine reuptake inhibitor for the treatment of obesity. Current Opinion in Investigational Drugs. 2009;10(10):1105-1116. PMID: 19777399. ↩ ↩2
-
Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. The Lancet. 2008;372(9653):1906-1913. PMID: 18950853. DOI: 10.1016/S0140-6736(08)61525-1. ↩
-
Saniona AB. Tesofensine / Tesomet pipeline. https://saniona.com/pipeline/tesofensine. Accessed June 2026. ↩ ↩2
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Frequently Asked Questions About Tesofensine
Is Tesofensine injected?
No. Tesofensine is administered orally as a tablet or capsule, once daily. There is no injection, no reconstitution, no needle, and no subcutaneous administration. This distinguishes it from peptide anti-obesity drugs such as semaglutide and tirzepatide.
What doses were used in the Tesofensine Phase 2 trial?
In Astrup et al. (Lancet 2008; PMID 18950853) tesofensine was studied at 0.25 mg, 0.5 mg, and 1.0 mg once daily over 24 weeks. The 1.0 mg dose produced the largest weight loss (approximately 12.8% total body weight reduction) but also the highest rates of side effects.
Is there an FDA-approved Tesofensine dose?
No. Tesofensine is not FDA-approved for any indication as of June 2026. There is no FDA-approved dose, no labeled indication, and no US-prescribed protocol. Doses cited here are from published clinical trials and are not recommendations for use.
Does Tesofensine require reconstitution?
No. Tesofensine is a small-molecule oral drug. Unlike peptide anti-obesity drugs (semaglutide, tirzepatide, retatrutide) which require reconstitution from lyophilized powder for injection, tesofensine is taken as a tablet or capsule with no preparation needed.
How is Tesomet dosed?
Tesomet pairs tesofensine with the cardioselective beta-1 blocker metoprolol in a fixed-dose combination. Exact dose-ratios depend on the indication under study (general obesity, hypothalamic obesity, or Prader-Willi syndrome); for current protocols, consult Saniona's ClinicalTrials.gov registrations.
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.