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Tesofensine research

What published studies found for Tesofensine: 8 papers, 5 in humans, with sample sizes and key results, plus 11 registered clinical trials.

B
Some human evidence
Why: One 24-week phase 2 obesity RCT (203 people, under a Lancet expression of concern) plus pooled neurology trials show weight loss; no phase 3 data.

Tesofensine (a small-molecule triple monoamine reuptake inhibitor, not a peptide) produced about 4.5-10.6% weight loss vs 2% with placebo in one 24-week phase 2 RCT of 203 people and modest weight loss in pooled neurology trials, but it raises heart rate, the key obesity trial later received a Lancet expression of concern, and a letter flagged under-reporting of its adverse effects; no phase 3 results appear in the candidates.

✓ 1 positive~ 5 mixed? 2 inconclusive

The main obesity trial is under a Lancet expression of concern, and adverse effects may have been under-reported.

US compounding: Not compoundable. Not an FDA-approved drug and not nominated for FDA's 503A bulks list, so US pharmacies can't legally compound it. Status for every peptide.

Browse and filter these papersTesofensine prices and vendors

Reported side effects

Registered clinical trials

11 trials of Tesofensine on ClinicalTrials.gov: 0 active, 11 completed, 4 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
Study to Investigate the Pharmacokinetic ProfileNCT03286829 · started 2017-12-18 · results postedCompletedPhase 160Saniona
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes MellitusNCT02737891 · started 2016-04 · results postedCompletedPhase 260Saniona
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)NCT03845075 · started 2019-02-25 · results postedCompletedPhase 221Saniona
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)NCT03149445 · started 2017-03-30 · results postedCompletedPhase 218Saniona
An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's TypeNCT00153010 · started 2003-02CompletedPhase 2430Boehringer Ingelheim
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)NCT00148486 · started 2003-06CompletedPhase 2261Boehringer Ingelheim
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 FluctuationsNCT00148512 · started 2003-03CompletedPhase 2254Boehringer Ingelheim
Effect of Tesofensine on Weight Reduction in Patients With Obesity.NCT00394667 · started 2006-09CompletedPhase 2200NeuroSearch A/S
Evaluation of Long Term Safety of Tesofensine in Patients With ObesityNCT00481104 · started 2007-05CompletedPhase 2140NeuroSearch A/S
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's DiseaseNCT00006077 · started 2000-08CompletedPhase 250National Institute of Neurological Disorders and Stroke (NINDS)
Effect of Tesofensine on Energy Balance in Humans.NCT00428415 · started 2007-03CompletedPhase 1, Phase 232NeuroSearch A/S

All 11 Tesofensine trials, with countries and recruiting status

Meta-analyses & systematic reviews

~ Mixedmeta-analysisObesity (Silver Spring) · 2008

Weight loss produced by tesofensine in patients with Parkinson's or Alzheimer's disease.

Meta-analysis of 4 randomized trials (tesofensine n=740, placebo n=228)Meta-analysis of four randomized, double-blind, multicenter trials14 weeks

Pooling 4 RCTs (968 patients) without any diet program, 14 weeks of tesofensine gave dose-dependent weight loss up to about 4% vs placebo, with heart rate rising up to 6.8 beats/min.

Key resultWeight change after 14 weeks was +0.5, -0.5, -0.9, -1.8, -2.8% with placebo and 0.125, 0.25, 0.5, 1.0 mg tesofensine (P = 0.015 for dose effect); heart rate rose up to 6.8 bpm, no effect on blood pressure
Studied
Patients with Parkinson's or Alzheimer's disease in trials of tesofensine
Compared with
Placebo
Main outcome
Change in body weight
Authors' conclusion
Tesofensine produced placebo-subtracted weight loss of about 4% over 14 weeks without diet or lifestyle therapy, similar to sibutramine but without a blood pressure effect.
Limitations
Patients had neurodegenerative disease, not obesity; only 14-21% were obese.
PubMed 18356831DOI

Human studies

~ Mixedhuman RCTLancet · 2008

Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial.

n = 203 humansPhase II randomised, double-blind, placebo-controlled trial24 weeks

In 203 obese adults on a diet, 24 weeks of tesofensine gave 4.5-10.6% weight loss vs 2.0% with placebo, but heart rate rose by 7.4 beats/min at 0.5 mg; dry mouth, nausea, constipation, diarrhea and insomnia were common.

Key resultMean weight loss 2.0% with diet and placebo vs 4.5%, 9.2% and 10.6% with tesofensine 0.25, 0.5 and 1.0 mg (p<0.0001); heart rate rose 7.4 beats per min with 0.5 mg (p=0.0001)
Studied
Obese patients (BMI 30 to 40 kg/m2) in five Danish centres, on an energy-restricted diet
Compared with
Placebo plus diet
Main outcome
Percentage change in bodyweight
Sample
203 obese patients randomized (placebo n=52; tesofensine 0.25 mg n=52, 0.5 mg n=50, 1.0 mg n=49); 161 completed
Authors' conclusion
Tesofensine 0.5 mg might produce weight loss twice that of currently approved drugs, but efficacy and safety need confirmation in phase III trials.
Limitations
Phase II; 21% did not complete; raised heart rate and frequent GI/sleep adverse events.
PubMed 18950853DOI
~ Mixedhuman RCTObesity (Silver Spring) · 2012

The effect of tesofensine on appetite sensations.

n = 158 humansPhase II trial: Part 1 randomized double-blind placebo-controlled; Part 2 open-label single-groupTwo 24-week parts separated by a 12-week drug-free period

In 158 obese adults, tesofensine increased satiety at 12 weeks, but this effect waned by 24 weeks and returned to baseline after stopping.

Key resultTesofensine dose-dependently increased composite satiety score at week 12, correlating with weight loss (r = 0.36, P < 0.0001); the score diminished over time and returned to baseline after withdrawal
Studied
Participants in a multicentre phase II obesity trial
Compared with
Placebo (Part 1)
Main outcome
Appetite sensations and composite satiety score
Sample
158 participants in Part 1; 113 in Part 2
Authors' conclusion
Enhanced satiety may be involved in early weight loss; it is unclear whether the attenuated appetite effect after 24 weeks reflects the weight-reduced state or diminishing drug effect.
Limitations
Part 2 was open-label and uncontrolled.
PubMed 21720440DOI
✓ Positivehuman RCTClin Pharmacol Ther · 2010

Subjective and objective effects of the novel triple reuptake inhibitor tesofensine in recreational stimulant users.

n = 52 humansSingle-dose, randomized, double-blind, crossover studyMeasures for 48 h after each dose

In 52 recreational stimulant users, single-dose tesofensine had abuse-related effects no different from placebo and lower than amphetamine, suggesting low abuse potential.

Studied
Recreational stimulant users
Compared with
Placebo, D-amphetamine (positive control), bupropion, atomoxetine
Main outcome
Subjective and objective abuse-related effects
Sample
52 recreational stimulant users (crossover)
Authors' conclusion
Tesofensine effects were not significantly different from placebo and abuse potential was no greater than bupropion or atomoxetine; it is unlikely to be recreationally abused.
Limitations
Single dose in recreational stimulant users.
PubMed 20520602DOI
~ Mixedhuman RCTArch Neurol · 2008

Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study.

HumansPilot phase 2 randomized, double-blind, placebo-controlled, parallel-group trial (ADVANS)14 weeks

In advanced Parkinson disease, tesofensine gave modest motor improvements at single doses without a dose-response, and GI and neuropsychiatric adverse events were more frequent, especially at higher doses.

Key resultDifference vs placebo of -4.7 points in UPDRS II+III with 0.5 mg (P =.005) and -7.1% in off time with 0.25 mg (P =.02); other dosages not significant
Studied
Patients with advanced Parkinson disease and levodopa-related motor fluctuations
Compared with
Placebo
Main outcome
UPDRS subscale II plus III score and percentage of waking hours in off time
Authors' conclusion
Patients showed modest improvements, but no dose-response could be established for efficacy and adverse reactions tended to be more frequent at higher dosages.
Limitations
Pilot trial; no clear dose-response; GI and neuropsychiatric adverse events more common.
PubMed 18474731DOI

Reviews

? InconclusivereviewLancet · 2013

Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial.

No new data

The Lancet published a formal expression of concern about the 2008 tesofensine obesity trial (no abstract available).

Authors' conclusion
An expression of concern was published about the 2008 tesofensine obesity trial (title only; no abstract available).
Limitations
No abstract available; details of the concern are not given here.
PubMed 23561987DOI
? InconclusivereviewLancet · 2013

Under-reporting of adverse effects of tesofensine.

No new data

Letter titled as raising under-reporting of tesofensine's adverse effects (no abstract available).

Authors' conclusion
A published letter on under-reporting of adverse effects of tesofensine (title only; no abstract available).
Limitations
No abstract available.
PubMed 23849924DOI

Animal & lab studies

~ MixedanimalObesity (Silver Spring) · 2013

Anti-hypertensive treatment preserves appetite suppression while preventing cardiovascular adverse effects of tesofensine in rats.

AnimalsCombined food intake and cardiovascular telemetry study of tesofensine with metoprolol or telmisartanAcute administration

In rats, tesofensine suppressed food intake but raised heart rate and blood pressure via sympathetic activation; metoprolol blocked the cardiovascular effects without reducing appetite suppression.

Studied
Telemetrized conscious rats
Compared with
Tesofensine alone vs combined with metoprolol or telmisartan
Main outcome
Food intake, heart rate and blood pressure
Authors' conclusion
Metoprolol fully prevented cardiovascular effects of tesofensine without affecting its reduction of food intake; telmisartan only partly reversed the blood pressure rise. Sympathetic activity appears to drive the cardiovascular effects.
Limitations
Acute rat study.
PubMed 23784901DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.