Corrected : The TIPO-1 trial summary misattributed the trial's largest weight-loss figure to the 0.5 mg dose. Per the trial abstract (Astrup et al., Lancet 2008), over 24 weeks mean weight loss exceeded diet plus placebo (2.0%) by 4.5% (0.25 mg), 9.2% (0.5 mg) and 10.6% (1.0 mg); the summary has been rewritten to match.
What Is Tesofensine? Benefits, Research & Safety
A triple monoamine reuptake inhibitor originally developed for neurological conditions, now researched for its potent effects on appetite suppression and weight loss.
UK summary: Not a licensed UK medicine and not a peptide (it's a small-molecule triple monoamine reuptake inhibitor). Investigational obesity drug; development was complicated by cardiovascular safety signals. Not currently available through regulated UK channels.
Quick Facts
Overview
Tesofensine — evidence and risk at a glance
Twenty standard modules scored against the Peptide Authority evidence grading methodology. Missing modules indicate the field has not yet been characterised editorially — treat absences as uncertainty rather than reassurance.
01Evidence snapshot
Not a licensed UK medicine and not a peptide (it's a small-molecule triple monoamine reuptake inhibitor). Investigational obesity drug; development was complicated by cardiovascular safety signals. Not currently available through regulated UK channels.
02Human evidence grade
03Preclinical evidence grade
04Regulatory status
- UK: Not approved. Investigational compound only.
- EU: Not approved. Remains in clinical development.
- Notes: Tesofensine has not received regulatory approval in any country. It remains an investigational drug with ongoing development efforts focused on optimising the benefit-risk profile.
05Approved medical uses
None in the UK or EU as a finished medicine. (Or: not yet documented; treat as absence rather than approval.)
06Unapproved / promotional claims
- More effective than Mounjaro or Wegovy for weight loss.
- Safer than GLP-1 agonists because it's a small molecule.
- Approved for private prescription in the UK.
- Reduces appetite without cardiovascular side effects.
07Common internet claims
- Marketed as the next obesity blockbuster by grey-market vendors.
- Sold alongside semaglutide as a 'stack' for weight-loss plateaus.
- Promoted in biohacker forums as cleaner than amphetamine-class appetite suppressants.
08Claim vs evidence
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “More effective than semaglutide for weight loss” | C | Limited | High | Phase 2 data show meaningful weight loss but cardiovascular tolerability concerns; not in a position to compare to licensed GLP-1 agents. |
| “Safe for general use” | E | No | High | Cardiovascular side-effect profile is the reason the compound stalled in development. |
| “Available privately in the UK” | E | No | High | Tesofensine is not licensed in the UK; any 'private supply' is outside the regulated medicines framework. |
09Safety uncertainty score
Effectively no human safety data; safety claims are extrapolations from animal work or anecdote.
10Known adverse signals
- Increased heart rate and blood pressure — the main reason development stalled.
- Insomnia, dry mouth, constipation, mood changes reported in Phase 2 trials.
- Theoretical interaction with SSRIs, MAOIs, stimulants, and cardiac drugs.
- Long-term cardiovascular safety not established.
11Drug-interaction uncertainty
Interaction picture sparse; meaningful uncertainty when combined with other medicines.
12Anti-doping status
13UK legal position
Not approved. Investigational compound only.
Read the full UK legal guide → Are peptides legal in the UK?
14EU legal position
Not approved. Remains in clinical development.
15What this page cannot tell you
- Whether a UK-purchased product contains tesofensine at the labelled dose.
- How it interacts with SSRIs, beta-blockers, or other cardiovascular medications.
- What the long-term cardiovascular risk profile is.
- Whether discontinuation causes rebound appetite or mood symptoms.
16Last reviewed
17Citation quality score
18Research gaps
- Phase 3 weight-loss outcome trial not completed.
- Cardiovascular outcome trial not completed.
- Long-term safety beyond ~24 weeks unstudied.
- Interaction profile with other psychoactive and cardiovascular drugs uncharacterised.
19Safer alternatives / established care pathways
- Licensed Wegovy (semaglutide) via NHS or GMC-registered prescriber.
- Licensed Mounjaro (tirzepatide) via NHS specialist or registered private clinic.
- NHS structured weight-management programme as first-line.
20Doctor discussion prompts
Questions to ask a qualified clinician
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is tesofensine licensed for any use in the UK?
- What licensed weight-management options should I consider first (semaglutide, tirzepatide)?
- Do I have any cardiovascular risk factors that would rule this out?
Discovery & History
Mechanism of Action
Researched Benefits
Based on preclinical and clinical research findings:
- 1Substantial weight loss of 10-13% in clinical trials
- 2Significant appetite suppression
- 3Potential enhancement of metabolic rate
- 4Improved glycaemic control in obese patients
- 5Reductions in waist circumference
- 6Improved lipid profiles
Claim vs Evidence
How popular claims about Tesofensine stack up against the current research, graded using our public evidence grading methodology.
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “More effective than semaglutide for weight loss” | C | Limited | High | Phase 2 data show meaningful weight loss but cardiovascular tolerability concerns; not in a position to compare to licensed GLP-1 agents. |
| “Safe for general use” | E | No | High | Cardiovascular side-effect profile is the reason the compound stalled in development. |
| “Available privately in the UK” | E | No | High | Tesofensine is not licensed in the UK; any 'private supply' is outside the regulated medicines framework. |
Theoretical Dosing & Protocols
| Theoretical Dosage | 0.25-0.5 mg daily in clinical trials (investigational) |
| Frequency | Once daily |
| Duration | 24 weeks in Phase II trials |
| Notes | Tesofensine is an investigational compound not approved for use. The information provided reflects clinical trial protocols and is for educational purposes only. The compound should not be used outside of clinical research settings. |
Administration Routes
Routes studied in research settings (educational only):
- Oral administration (capsule form in trials)
| Half-Life | Stability |
|---|---|
| Approximately 8-9 days (very long half-life) | Stable in appropriate pharmaceutical formulations |
Safety Profile & Known Risks
Commonly Reported Side Effects
- Increased heart rate (dose-dependent)
- Dry mouth
- Constipation
- Insomnia
- Headache
- Nausea
Rare Risks & Concerns
- Cardiovascular events (theoretical concern due to heart rate increase)
- Psychiatric effects (related to monoamine modulation)
- Blood pressure changes
- Potential for abuse/dependence (dopaminergic effects)
Contraindications
- Cardiovascular disease
- Uncontrolled hypertension
- History of psychiatric disorders
- Concurrent use of MAO inhibitors
- Pregnancy and breastfeeding
UK & EU Regulatory Context
🇬🇧 United Kingdom
Not approved. Investigational compound only.
🇪🇺 European Union
Not approved. Remains in clinical development.
Clinical Studies Summary
TIPO-1: Tesofensine for Obesity - Phase II Trial
Over 24 weeks with an energy-restricted diet, placebo produced a mean 2.0% weight loss; tesofensine produced mean weight loss greater than placebo by 4.5% (0.25 mg), 9.2% (0.5 mg) and 10.6% (1.0 mg) (p<0.0001). Heart rate rose by 7.4 beats/min in the 0.5 mg group.
Weight loss produced by tesofensine in patients with Parkinson's or Alzheimer's disease.
In the placebo group, 14% were obese and 21% were in the TE group. In the total cohort, weight change after 14 weeks was +0.5, -0.5, -0.9, -1.8, -2.8% in the placebo, 0.125, 0.25, 0.5 and 1.0 mg in the TE groups, respectively (P = 0.015 for dose effect).
Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity.
Tesomet was welltolerated, did not affect heart rate or blood pressure, and resulted in significant reductions in body weight compared to placebo in adults with hypothalamic obesity.
The effect of tesofensine on appetite sensations.
We postulate that enhanced satiety is involved in early weight loss. Whether the attenuated effect on appetite seen after 24 weeks is due to a counteracting effect in the weight reduced state or whether the appetite suppressing effect of TE per se diminishes over time is, however, still unclear.
Quantitative pharmacology approach in Alzheimer's disease: efficacy modeling of early clinical data to predict clinical outcome of tesofensine.
Various internal evaluation techniques confirmed the reliability and predictive performance of the PK/PD model, which also successfully predicted the 14-week PoC data. For tesofensine, the dose concentration-effect relationship has successfully been described in mild AD patients demonstrating the supportive value of PK/PD models in QP-A/MBDD in early phases of clinical development for decision-making.
Subjective and objective effects of the novel triple reuptake inhibitor tesofensine in recreational stimulant users.
The effects of tesofensine were either lower than or not different from those of bupropion or atomoxetine. These results demonstrate that the abuse potential for tesofensine is no greater than that of bupropion or atomoxetine, and tesofensine is therefore unlikely to be recreationally abused.
Registered Trials & Regulatory Status
6 of 11 completed trials have never posted results. Unreported trials are not neutral: results that go unpublished are more often negative ones.
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Status: Completed · 21 participants · Saniona
Conditions: Hypothalamic Injury-induced Obesity (HIO)
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
Status: Completed · 37 participants · Saniona
Conditions: Phase 1
Study to Investigate the Pharmacokinetic Profile
Status: Completed · 60 participants · Saniona
Conditions: Healthy Male Subjects
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Status: Completed · 18 participants · Saniona
Conditions: Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Status: Completed · 60 participants · Saniona
Conditions: Type 2 Diabetes Mellitus
Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
Status: Completed · 140 participants · NeuroSearch A/S
Conditions: Obesity
Effect of Tesofensine on Energy Balance in Humans.
Status: Completed · 32 participants · NeuroSearch A/S
Conditions: Obesity
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
Status: Completed · 200 participants · NeuroSearch A/S
Conditions: Obesity
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations
Status: Completed · 254 participants · Boehringer Ingelheim
Conditions: Parkinson Disease
An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
Status: Completed · 430 participants · Boehringer Ingelheim
Conditions: Alzheimer Disease
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease
Status: Completed · 50 participants · National Institute of Neurological Disorders and Stroke (NINDS)
Conditions: Parkinson's Disease
Adverse event reports (FDA FAERS)
Not applicable: no licensed product contains this peptide, so it is not reported through FAERS. This is an absence of surveillance, not evidence of safety.
Source: ClinicalTrials.gov and openFDA. Updated automatically.
Looking for Tesofensine?
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View at SupplierFrequently Asked Questions
Questions to ask a qualified clinician about Tesofensine
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is tesofensine licensed for any use in the UK?
- What licensed weight-management options should I consider first (semaglutide, tirzepatide)?
- Do I have any cardiovascular risk factors that would rule this out?
UK regulatory & safety context
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