Investigational monoamine reuptake inhibitor · Fact sheet
Tesofensine
Also known as NS-2330
Tesofensine is a small-molecule monoamine reuptake inhibitor studied for obesity. A controlled trial found weight reduction together with increased heart rate and other adverse effects. It is not an FDA-approved weight-loss drug.
What is Tesofensine?
Tesofensine affects norepinephrine, dopamine and serotonin reuptake. It is not a peptide or a GLP-1 receptor agonist.
Tesofensine alone and Tesomet, which also contains metoprolol, are different treatments.
Benefits & claims
Interest centers on appetite and weight reduction. Cardiovascular and psychiatric effects are central to interpreting the weight findings.
What the evidence supports
- The 0.5 mg group lost an average 9.2 percentage points more body weight than the diet-and-placebo group over 24 weeks.
- Heart rate increased by 7.4 beats per minute in that group.
- Historical comparisons with drugs available in 2008 cannot rank tesofensine against current obesity medicines.
Research areas
- Obesity
- Appetite sensations
Dosage & frequency
Human study contextThe original phase 2 obesity study provides trial amounts, not an approved prescribing schedule.
2008 Danish phase 2 tesofensine trial
203 adults with obesity, alongside an energy-restricted diet
- Amount
- 0.25, 0.5 or 1.0 mg in separate groups
- Frequency
- Daily for 24 weeks after a run-in period
- Route studied or labeled
- Oral
The study compared separate tesofensine groups with placebo. The 0.5 mg group had an increased heart rate. This is monotherapy research and does not specify a Tesomet schedule or establish chronic safety.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- Tesofensine affects norepinephrine, dopamine and serotonin reuptake. It is not a peptide or a GLP-1 receptor agonist.
Formulation differences
- Tesofensine alone and Tesomet, which also contains metoprolol, are different treatments.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- Long-term cardiovascular and psychiatric safety
- Durability of weight effects
- Benefit-risk comparison with current approved treatments
Side effects & risks
- Dry mouth, nausea, constipation and insomnia were common in the trial; heart rate increased.
- Psychiatric and cardiovascular safety and interactions with other monoamine-active drugs require careful evaluation.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Early human evidenceA 203-person phase 2 obesity trial found dose-dependent weight reduction over 24 weeks. Long-term safety and comparison with current approved medicines require additional direct evidence.
Studies
203 participants; 24-week weight and heart-rate outcomes.
Appetite effects diminished over time and returned after reintroduction.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Tesofensine is not FDA approved. Saniona describes a partner application under review in Mexico; a pending non-U.S. application is not an approval.
Phase 2 research; no FDA-approved product
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
Open questions
- Long-term cardiovascular and psychiatric safety
- Durability of weight effects
- Benefit-risk comparison with current approved treatments
Summary
Historical comparisons with drugs available in 2008 cannot rank tesofensine against current obesity medicines.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- pubmedTesofensine appetite follow-up
Appetite effects diminished over time and returned after reintroduction.
- company releaseSaniona: tesofensine partnership and application
Company disclosure of an application under review, not regulatory approval.