Clinical2008
A phase 2 RCT reported dose-dependent weight loss (up to ~10% body weight at 0.5 mg/day over 24 weeks) in obese patients; the paper later received an Expression of Concern over trial irregularities.
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Tesofensine
Overview
Last reviewed: 2026-08-18
Identity & Aliases
Also known as
TesofensineNS2330Tesofensine citrate
Full composition (formula, molecular weight, sequence) in Quick Facts →
Research Areas
Obesity / weight managementTriple monoamine reuptake inhibitionAppetite suppression / energy expenditure
Available Evidence
Human
A 6-month randomized, double-blind, placebo-controlled phase 2 trial (Astrup et al., Lancet 2008) reported dose-dependent weight loss of up to ~10% of body weight with tesofensine 0.5 mg/day. That publication carries a 2013 Expression of Concern from The Lancet over trial irregularities. Phase 3 development stalled when the original sponsor ran into difficulties, and the drug is not approved anywhere.
Animal
Animal studies show tesofensine reduces food intake and increases energy expenditure/thermogenesis, consistent with triple monoamine reuptake inhibition.
In Vitro
Cell-based assays confirm potent inhibition of dopamine, norepinephrine, and serotonin transporters.
Uncertain
Cardiovascular signals (heart-rate and blood-pressure increases) and the reliability of the pivotal weight-loss data are major open questions; off-label/gray-market use is unregulated.
Key Studies & Findings
Clinical2013
The Lancet issued an Expression of Concern about the 2008 tesofensine trial due to irregularities in trial conduct.
Benefits & Effects
Appetite suppression
Increased energy expenditure.
Triple reuptake inhibitor
Appetite suppression
Increased energy expenditure.
Side Effects & Safety
Interaction
Avoid: MAOIs
Interaction
Avoid: MAOIs
Limitations & Open Questions
The pivotal phase 2 weight-loss data are formally disputed (Lancet Expression of Concern 2013). Phase 3 development stalled and no product is approved; safety signals (heart rate, blood pressure) and widespread unregulated use are significant caveats.
Pharmacology
Triple monoamine (dopamine, norepinephrine, serotonin) reuptake inhibitor with a long elimination half-life supporting once-daily oral dosing; reduces appetite and increases energy expenditure. Originally developed as NS2330 for Parkinson's and Alzheimer's disease, where it failed to show benefit.
Research Protocols
Standard Weight Loss
- Dose
- 0.5mg
- Frequency
- Once daily in the morning
- Route
- Oral
Conservative/Starting Dose
- Dose
- 0.25mg
- Frequency
- Once daily in the morning
- Route
- Oral
Maximum Studied Dose
- Dose
- 1.0mg
- Frequency
- Once daily (higher side effect rate)
- Route
- Oral
Research protocols are for educational purposes only. Always consult qualified medical professionals.
Frequently Asked Questions
Is tesofensine approved for weight loss?
No. It is not approved anywhere; phase 3 development stalled and the main phase 2 paper carries a Lancet Expression of Concern.
How much weight loss did tesofensine trials show?
The 2008 phase 2 trial reported up to ~10% body-weight loss at 0.5 mg/day over 24 weeks, but the reliability of those data is disputed.
Why was tesofensine originally developed?
As NS2330 it was tested for Parkinson's and Alzheimer's disease before its weight-loss effect redirected development toward obesity.
Research Citations
1
TIPO-1 Phase IIB Trial (2008)
(2008)
2
TIPO-4 Extension Trial (48 weeks)
()
3
Viking Phase 3 Trial (2018)
(2018)
Related Resources
Quick Facts
Citations
31.TIPO-1 Phase IIB Trial (2008)
(2008)
2.TIPO-4 Extension Trial (48 weeks)
()
3.Viking Phase 3 Trial (2018)
(2018)