Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Sanionan = 1830 Mar 2017 to 22 Jul 2019
Confirmed Genetic Diagnosis of Prader-Willi Syndrome
PepBank has 25 tesofensine studies with results. 16 of them gave tesofensine, with 90 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.
Searches 90 results and 57 papers. Newer studies from Europe PMC
Identifiers, parent molecule, targets and development stage, from curated data.
Tesofensine is a small molecule with four defined stereocentres. It inhibits monoamine reuptake. Saniona describes oral development for obesity with partner Medix. Its pipeline page states that Medix submitted an application to COFEPRIS. A favorable technical committee opinion is not marketing authorisation. Tesomet adds metoprolol, so combination results must remain distinct.
| Target | Action | Evidence |
|---|---|---|
| Dopamine, serotonin and noradrenaline transporters | Reuptake inhibitor | sponsor descriptionSource (opens in a new tab) |
Structure from the identity record.
Draws the structure in your browser with RDKit (about 2.3 MB, loaded once).
SMILES fromPubChem CID 11370864(opens in a new tab)
CCOC[C@H]1[C@H]2CC[C@H](N2C)C[C@@H]1C3=CC(=C(C=C3)Cl)ClPeople first in each area, then animals, then lab cells. Counts are exact and come from studies that gave the peptide.
PepBank reads each paper before it shows the results. This search looks in Europe PMC for newer papers that PepBank has not read yet.
Counts are exact and come from studies that gave the peptide.
Studies by year
25 of 57 studies have results (44%), published 2004 to 2025. Top row: every study. Bottom row: studies with results about Tesofensine, by class. The rows use different scales.
Studies57 in all, 2001 to 2026
Studies with results25 in all, 2004 to 2025
Retracted studies are left out. A study with results in two classes counts in both.
AI wrote and checked these results. AI can make mistakes, so check important results against the source.
Registered trials that test the peptide, with phase, status and dates. A dot marks trials with posted results.
14 trials match. Highest phase first. Data from ClinicalTrials.gov.
14 trials · 12 completed · 2 stopped early · 5 with posted results
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease
NCT00006077Aug 2000 to Jul 2003
An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
NCT00153010Feb 2003 to Mar 2005 (primary)
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
NCT00148512Mar 2003 to Feb 2005
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)
NCT00148486Jun 2003 to Mar 2005 (primary)
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
NCT00394667Sept 2006 to Sept 2007
Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
NCT00481104May 2007 to Nov 2008
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
NCT02737891Apr 2016 to Mar 2017
14 trials · 12 completed · 2 stopped early · 5 with posted results · source ClinicalTrials.gov (opens in a new tab)
Sanionan = 1830 Mar 2017 to 22 Jul 2019
Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Sanionan = 2125 Feb 2019 to 16 Oct 2020
Hypothalamic Injury-induced Obesity (HIO)
Sanionan = 011 Nov 2021 to 9 Dec 2022
Hypothalamic Obesity
Sanionan = 028 Dec 2021 to 9 Dec 2022
Prader-Willi Syndrome
Sanionan = 60Apr 2016 to Mar 2017
Type 2 Diabetes Mellitus
Boehringer Ingelheimn = 261Jun 2003 to Mar 2005 (primary)
Parkinson Disease
Boehringer Ingelheimn = 254Mar 2003 to Feb 2005
Parkinson Disease
Boehringer Ingelheimn = 430Feb 2003 to Mar 2005 (primary)
Alzheimer Disease
NeuroSearch A/Sn = 200Sept 2006 to Sept 2007
Obesity
NeuroSearch A/Sn = 140May 2007 to Nov 2008
Obesity
NeuroSearch A/Sn = 32Mar 2007 to Dec 2007
Obesity
National Institute of Neurological Disorders and Stroke (NINDS)n = 50Aug 2000 to Jul 2003
Parkinson's Disease
Sanionan = 3711 Jul 2018 to 6 Jun 2019
Phase 1
Sanionan = 6018 Dec 2017 to 6 Feb 2018
Healthy Male Subjects
Studies on this peptide. Some have results. The others have none yet.
57 studies match. Retracted studies are left out.
Showing 24 of 57 studiesquery qry_96189b397d97f36cface0646
25 studies in all, 12 on this page
Not a test of Tesofensine alone · 2022
Huynh et al. 2022European journal of endocrinologycited by 38
PMID 35294397PMC9175551DOI 10.1530/eje-21-0972PUB-35294397
Randomized controlled trial · 2004
Bara-Jimenez et al. 2004Movement disorders : official journal of the Movement Disorder Societyn = 9cited by 37
PMID 15390018DOI 10.1002/mds.20124PUB-15390018
Randomized controlled trial · 2007
Hauser et al. 2007Movement disorders : official journal of the Movement Disorder Societycited by 37
PMID 17149725DOI 10.1002/mds.21258PUB-17149725
Animal study (in vivo) · rat · 2010
Axel et al. 2010Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 37
PMID 20200509PMC3055463DOI 10.1038/npp.2010.16PUB-20200509
Randomized controlled trial · 2010
Sjödin et al. 2010International journal of obesity (2005)n = 32cited by 37
PMID 20479765DOI 10.1038/ijo.2010.87PUB-20479765
Animal study (in vivo) · rat · 2007
Larsen et al. 2007European journal of pharmacologycited by 36
PMID 17112503DOI 10.1016/j.ejphar.2006.10.029PUB-17112503
Randomized controlled trial · 2010
Schoedel et al. 2010Clinical pharmacology and therapeuticsn = 52cited by 34
PMID 20520602DOI 10.1038/clpt.2010.67PUB-20520602
Randomized controlled trial · 2012
Gilbert et al. 2012Obesity (Silver Spring, Md.)cited by 32
PMID 21720440DOI 10.1038/oby.2011.197PUB-21720440
Not a test of Tesofensine alone · 2008
Lehr et al. 2008British journal of pharmacologycited by 31
PMID 17982477PMC2199391DOI 10.1038/sj.bjp.0707539PUB-17982477
Animal study (in vivo) · rat · 2010
Hansen et al. 2010European journal of pharmacologycited by 30
PMID 20385125DOI 10.1016/j.ejphar.2010.03.026PUB-20385125
Not a test of Tesofensine alone · 2009
Lehr et al. 2009Clinical pharmacokineticscited by 28
PMID 19705923DOI 10.2165/11313370-000000000-00000PUB-19705923
Randomized controlled trial · 2008
Rascol et al. 2008Archives of neurologycited by 27
PMID 18474731DOI 10.1001/archneur.65.5.577PUB-18474731
29 studies in all, 12 on this page
PubMed tag: Review · 2018
Srivastava et al. 2018Current obesity reportscited by 146
PMID 29504049DOI 10.1007/s13679-018-0300-4PUB-29504049
PubMed tag: Review · 2012
Derosa et al. 2012Expert opinion on drug safetycited by 129
PMID 22439841DOI 10.1517/14740338.2012.675326PUB-22439841
PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase II · 2008
Astrup et al. 2008Lancet (London, England)cited by 127
PMID 18950853DOI 10.1016/s0140-6736(08)61525-1PUB-18950853
PubMed tag: review-article · 2011
Ioannides-Demos et al. 2011Journal of obesitycited by 102
PMID 21197148PMC3006492DOI 10.1155/2011/179674PUB-21197148
PubMed tag: Review · 2010
Halford et al. 2010Nature reviews. Endocrinologycited by 101
PMID 20234354DOI 10.1038/nrendo.2010.19PUB-20234354
PubMed tag: Review · 2018
Coulter et al. 2018Drugscited by 95
PMID 30014268PMC6095132DOI 10.1007/s40265-018-0946-yPUB-30014268
PubMed tag: review-article, Review · 2011
Nathan et al. 2011CNS neuroscience & therapeuticscited by 81
PMID 21951371PMC6493804DOI 10.1111/j.1755-5949.2010.00172.xPUB-21951371
PubMed tag: Review · 2010
Kennett et al. 2010Pharmacology, biochemistry, and behaviorcited by 52
PMID 20688100DOI 10.1016/j.pbb.2010.07.020PUB-20688100
PubMed tag: Review · 2005
Wu et al. 2005CNS drugscited by 50
PMID 16142989DOI 10.2165/00023210-200519090-00001PUB-16142989
PubMed tag: Review · 2011
Halford et al. 2011Drugscited by 44
PMID 22085383DOI 10.2165/11596680-000000000-00000PUB-22085383
PubMed tag: Meta-Analysis · 2008
Astrup et al. 2008Obesity (Silver Spring, Md.)cited by 39
PMID 18356831DOI 10.1038/oby.2008.56PUB-18356831
PubMed tag: Review · 2014
Heal et al. 2014Neuropharmacologycited by 31
PMID 24953830DOI 10.1016/j.neuropharm.2014.06.012PUB-24953830
These studies name Tesofensine but give no result for it (for example, the results concern another peptide in the study).
PubMed tag: Review, Comparative Study · 2014
George et al. 2014Journal of cardiovascular pharmacology and therapeuticscited by 44
PMID 24064009DOI 10.1177/1074248413501017PUB-24064009
Page 1 of 1
Rascol O · Archives of neurology · 2008
Randomized controlled trial · 6 results
Schoedel KA · Clinical pharmacology and therapeutics · 2010
Randomized controlled trial · 4 results
Sjödin A · International journal of obesity (2005) · 2010
Randomized controlled trial · 7 results
Bara-Jimenez W · Movement disorders : official journal of the Movement Disorder Society · 2004
Randomized controlled trial · 4 results
Hauser RA · Movement disorders : official journal of the Movement Disorder Society · 2007
Randomized controlled trial · 10 results
Gilbert JA · Obesity (Silver Spring, Md.) · 2012
Randomized controlled trial · 6 results
Nielsen AL · Ugeskrift for laeger · 2009
Randomized controlled trial · 3 results
Appel L · European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2014
Non-randomized trial · 4 results
Axel AM · Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2010
Animal study (in vivo) · rat · 9 results
Larsen MH · European journal of pharmacology · 2007
Animal study (in vivo) · rat · 8 results
Hansen HH · European journal of pharmacology · 2010
Animal study (in vivo) · rat · 10 results
Hansen HH · Pharmacology, biochemistry, and behavior · 2013
Animal study (in vivo) · rat · 8 results
Bentzen BH · Obesity (Silver Spring, Md.) · 2013
Animal study (in vivo) · rat · 9 results
van de Giessen E · European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2012
Animal study (in vivo) · rat · 10 results
Perez CI · PloS one · 2024
Animal study (in vivo) · mouse and rat · 11 results
Lopez A · PloS one · 2025
Animal study (in vivo) · rat · 4 results
Huynh K · Journal of the Endocrine Society · 2021
Not a test of Tesofensine alone · 17 results
Journal of the Endocrine Society · 2022
Not a test of Tesofensine alone · 14 results
Huynh K · European journal of endocrinology · 2022
Not a test of Tesofensine alone · 9 results
Lehr T · British journal of clinical pharmacology · 2007
Not a test of Tesofensine alone · 8 results
Lehr T · Clinical pharmacokinetics · 2010
Not a test of Tesofensine alone · 7 results
Lehr T · British journal of pharmacology · 2008
Not a test of Tesofensine alone · 6 results
Lehr T · The AAPS journal · 2010
Not a test of Tesofensine alone · 3 results
Lehr T · Clinical pharmacokinetics · 2009
Not a test of Tesofensine alone · 2 results
Li Y · Nature communications · 2025
Not a test of Tesofensine alone · 1 result
Approval and sport status, and the safety outcomes reported in study results. Laws and labels change, so check the regulator for the current status.
| Jurisdiction | Body | Status | As of | Source |
|---|---|---|---|---|
| US | FDA | The openFDA active ingredient search returned no matches. This confirms no matching entry in this database, not worldwide absence of approval. | 22 Oct 2026 | api.fda.gov (opens in a new tab) |
| EU | EMA | No authorised exact product match was found in the EMA central medicine catalogue. National authorisations are outside this check. | 22 Oct 2026 | ema.europa.eu (opens in a new tab) |
| Sport | WADA | Banned in sport (WADA S6.B) Tesofensine is named among specified stimulants. | 2026 List | wada-ama.org (opens in a new tab) |
| Mexico | Note | Not approved in Mexico. Medix submitted a marketing application to COFEPRIS. Saniona reported on 2024-11-06 that COFEPRIS had not yet approved it, and its interim report for the first quarter of 2026 says the application is under review. A favorable 2023 technical committee opinion is not an approval. The COFEPRIS register was not searched directly. | 22 Oct 2026 | inderes.se (opens in a new tab) |
15 safety results for Tesofensine.
In advanced Parkinson disease, adding NS 2330 to levodopa did not appear to alter levodopa-associated dyskinesia severity versus placebo.
Randomized controlled trialn = 9
In advanced Parkinson disease, NS 2330 was well tolerated.
Randomized controlled trialn = 9
In early Parkinson disease, tesofensine was generally well tolerated.
Randomized controlled trialn not reported
In early Parkinson disease, constipation was among the most commonly reported tesofensine adverse events.
Randomized controlled trialn not reported
In early Parkinson disease, insomnia was among the most commonly reported tesofensine adverse events.
Randomized controlled trialn not reported
In early Parkinson disease, dry mouth was among the most commonly reported tesofensine adverse events.
Randomized controlled trialn not reported
In early Parkinson disease, decreased body weight was common with tesofensine 1.0 mg.
Randomized controlled trialn not reported
In early Parkinson disease, elevated heart rate was common with tesofensine 1.0 mg.
Randomized controlled trialn not reported
In rats, acute tesofensine increased heart rate.
Animal study (in vivo)rat
In rats, acute tesofensine increased blood pressure.
Animal study (in vivo)rat
In the rodent study, tesofensine caused few, if any, head-weaving stereotypies at therapeutic doses, unlike phentermine.
Animal study (in vivo)mice and rats
In rats, tesofensine elicited head-weaving only in females, at a lower extent than other dopaminergic agents.
Animal study (in vivo)rat
In rats, tesofensine was most frequently associated with orolingual dyskinesia.
Animal study (in vivo)rat
The doses that these studies used. They are not recommendations.
0.5 mg dailyHuman
0.25 mg dailyHuman
2.0 mg daily for 7 days, then 1.0 mg daily for 7 daysHuman
0.25 mg dailyHuman
0.5 mg dailyHuman
1.0 mg dailyHuman
6 of 21 shown
PepBank is a research reference. Talk to a doctor before you use any peptide.
Data version, change history and code for this peptide.
curl -s https:// pepbank.io/ v1/ briefs/ tesofensineEvidence summary for Tesofensine: counts by class, key results with sources, notices, data version.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Top outcomes
The 8 outcome groups with the most study results, by evidence class.
Data version 308560. Bar length is the number of results, not the size of an effect.
Evidence matrix
Study results by outcome and evidence class. Arrows show how the measured outcome moved, not whether the change is good.
| Outcome group | Human | Animal | Lab | Computer model | Total |
|---|---|---|---|---|---|
| Exercise and physical functionNervous system and cognition | Human: 9 results from 3 studies: 3 decrease, 6 no significant change. Strongest design: Randomized controlled trial | No results | No results | No results | 9 |
| Appetite and food intakeMetabolic and weight | Human: 7 results from 2 studies: 5 increase, 1 decrease, 1 mixed. Strongest design: Randomized controlled trial | Animal: 12 results from 6 studies: 2 increase, 7 decrease, 2 no significant change, 1 not reported. Strongest design: Animal study (in vivo) | No results | No results | 19 |
| Adverse eventsWhole body | Human: 6 results from 3 studies: 2 increase, 1 no significant change, 3 not reported. Strongest design: Randomized controlled trial | Animal: 3 results from 2 studies: 1 decrease, 1 mixed, 1 not reported. Strongest design: Animal study (in vivo) | No results | No results | 9 |
| Body weightMetabolic and weight | Human: 5 results from 3 studies: 5 decrease. Strongest design: Randomized controlled trial | Animal: 12 results from 6 studies: 3 increase, 9 decrease. Strongest design: Animal study (in vivo) | No results | No results | 17 |
| Addiction, withdrawal and alcohol intakeNervous system and cognition | Human: 4 results from 1 study: 1 decrease, 1 no significant change, 2 mixed. Strongest design: Randomized controlled trial | No results | No results | No results | 4 |
| Energy expenditure and thermogenesisMetabolic and weight | Human: 3 results from 1 study: 2 increase, 1 no significant change. Strongest design: Randomized controlled trial | No results | No results | No results | 3 |
| Gastrointestinal adverse eventsGastrointestinal | Human: 2 results from 2 studies: 1 increase, 1 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 2 |
| Receptor activity and mechanismNervous system and cognition | Human: 1 result from 1 study: 1 increase. Strongest design: Non-randomized trial | Animal: 12 results from 3 studies: 3 increase, 5 decrease, 1 no significant change, 1 mixed, 2 not reported. Strongest design: Animal study (in vivo) | No results | No results | 13 |
| PharmacokineticsPharmacology | Human: 1 result from 1 study: 1 increase. Strongest design: Randomized controlled trial | No results | No results | No results | 1 |
| SleepSleep | Human: 1 result from 1 study: 1 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 1 |
| NeuroprotectionNervous system and cognition | No results | Animal: 8 results from 1 study: 4 increase, 4 no significant change. Strongest design: Animal study (in vivo) | No results | No results | 8 |
| Blood pressureCardiovascular | No results | Animal: 1 result from 1 study: 1 increase. Strongest design: Animal study (in vivo) | No results | No results | 1 |
12 outcome groups shown of 15 · 90 study results
Data version 308560. Shade grows with the number of results. Every cell shows the exact count.
Trials by phase
14 registered trials, grouped by phase and shown by status.
Source: ClinicalTrials.gov, data version 308560. Status is the registry status.