Tesofensine quick reference
What is Tesofensine?
Daily pill that blocks brain chemical reuptake to cut appetite.
Used for strong appetite and craving control.
Not approved in the US or EU.
How Tesofensine works
Raises noradrenaline, dopamine and serotonin signaling.
Cuts hunger and food seeking in the brain.
Heart rate rose in trials.
What Tesofensine is studied for
0.5 mg gave 9.2% more loss than diet alone.
1.0 mg gave 10.6% more loss than diet alone.
Pooled trials showed small weight loss at 14 weeks.
With metoprolol: 6.3% extra loss in 21 adults.
Obese rats ate less and lost weight.
Tesofensine dosing protocol
| Daily pill amount | How long |
|---|---|
| 0.25 mg | 24 weeks |
| 0.5 mg | 24 weeks |
| 1.0 mg | 24 weeks |
| Route | Pill by mouth, once a day |
From Astrup A et al. Lancet 2008 (NCT00394667). This is a trial schedule. There is no label.
Label and trial amounts come from the sources below. Community amounts are what people report; they have not been tested.
Mixing
Oral pill. No mixing needed.
What the research found
Phase 2 trial in Denmark, 203 adults with obesity, 24 weeks, with a diet. The numbers are the extra weight loss compared with diet plus placebo (placebo group lost 2.0%):
Astrup A et al. Lancet 2008;372:1906-13 (PubMed 18950853), NCT00394667. The authors said phase 3 trials were needed.
Tesofensine community experience
What users report. Not tested in trials.
Positive reports
- Less food noise Fewer cravings and less constant food thinking.
- Steady loss Some see weight drop steadily over weeks.
- Focus Some report better focus and drive early on.
Negative & mixed
- Dry mouth, constipation Both recur across reports.
- Pulse Palpitations or a higher resting heart rate.
- Sleep and mood Insomnia, anxiety or low mood can appear.
Tesofensine stacking
Combo pill (Tesomet) tested in 21 adults.
Different mechanisms. Not studied together.
Both cut appetite. Not studied together.
Tesofensine side effects & safety
Common
- Dry mouth, nausea, constipation, hard stools, diarrhea.
- Trouble sleeping.
- Heart rate up 7.4 beats/min at 0.5 mg.
- Headache: 36% on Tesomet vs 0% placebo.
- More effects at higher doses.
Less common
- Anxiety or irritability at higher doses.
- One person stopped Tesomet for worse anxiety.
- Long-term heart safety is unknown.
Precautions
- Serotonin or stimulant drugs: interaction risk by mechanism.
- Heart disease, high blood pressure or fast pulse: avoid or monitor.
- Mood or anxiety disorders: can worsen.
- Pregnancy or breastfeeding: no data.
- Track pulse, blood pressure, sleep and mood.
Our verdict on Tesofensine
A real appetite drug with a troubled trial record. Its 2008 Lancet trial carries an expression of concern.
Tesofensine FAQ
Is tesofensine a peptide?
No. It is a small-molecule pill.
Is it approved?
No, not in the US or EU.
What is the Lancet concern?
In 2013 the Lancet flagged the 2008 trial; a letter cited under-reporting of side effects.
What does it do to heart rate?
It raised pulse 7.4 beats/min at 0.5 mg.
Sources
- Astrup A et al. Lancet 2008, tesofensine in obese patients, NCT00394667 (PubMed 18950853)
- ClinicalTrials.gov NCT00394667
- Saniona AB / Inderes release: Mexican application for tesofensine not yet approved (Nov 2024)
- Expression of concern: effect of tesofensine on bodyweight loss... Lancet 2013;381:1167 (PubMed 23561987); letter: Under-reporting of adverse effects of tesofensine, Lancet 2013 (PubMed 23849924)
- Randomized controlled trial of Tesomet (tesofensine/metoprolol) for weight loss in hypothalamic obesity. Eur J Endocrinol 2022 (PubMed 35294397)
- Weight loss produced by tesofensine in patients with Parkinson's or Alzheimer's disease. Obesity 2008 (PubMed 18356831)
- Tesofensine in advanced Parkinson disease (ADVANS). Arch Neurol 2008 (PubMed 18474731)