Clinical Trials

Numerous clinical trials have evaluated entacapone across conditions such as Parkinson's disease, methamphetamine dependence, autonomic nervous system diseases, and obesity. Spanning Early Phase 1 bioequivalence studies through Phase 4 protocols, these initiatives are funded by pharmaceutical sponsors like Novartis and Orion Corporation, university hospitals, and government entities including the National Institute of Neurological Disorders and Stroke. Trial records encompass active, recruiting, completed, terminated, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07151378 RECRUITING
PARKINSON DISEASE (Disorder)
University Hospital Tuebingen
 2025-10-27 PHASE3
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
 1997-04 PHASE1; PHASE2
NCT04246437 RECRUITING
Autonomic Failure; Pure Autonomic Failure; Parkinson Disease; Multiple System Atrophy; Dementia With Lewy Bodies
Daniel Claassen
 2020-02-04 PHASE1
NCT06115538 UNKNOWN
Parkinson Disease; Treatment Adherence
Ankara Ataturk Sanatorium Training and Research Hospital
 2023-10-01 PHASE4
NCT06236230 UNKNOWN
Parkinson Disease
Second Affiliated Hospital of Soochow University
 2023-11-15 PHASE4
NCT06180720 UNKNOWN
Healthy
The Affiliated Hospital of Qingdao University
 2023-12-20 PHASE1
NCT05976737 UNKNOWN
Healthy
The Affiliated Hospital of Qingdao University
 2023-08-17 PHASE1
NCT04006769 COMPLETED
Gastrointestinal Stromal Tumor, Malignant
Xiangya Hospital of Central South University
 2020-10-30 EARLY_PHASE1
NCT02452606 UNKNOWN
Parkinson Disease; Sleep Disorders
Asan Medical Center
 2015-03
NCT02058966 COMPLETED
Methamphetamine Dependence
Oregon Health and Science University
 2014-06 EARLY_PHASE1
NCT00044083 TERMINATED
Schizophrenia
National Institute of Mental Health (NIMH)
 2002-08 PHASE2
NCT02554734 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
 2015-08 PHASE1
NCT02349243 UNKNOWN
Obesity
Kaichun Wu
 2015-01 PHASE1; PHASE2
NCT02448914 COMPLETED
Parkinson's Disease
LobSor Pharmaceuticals AB
 2015-05 PHASE1
NCT01883505 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
 2014-01-06 PHASE2
NCT02096601 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
 2014-08-11 PHASE1
NCT01840423 COMPLETED
Healthy
Orion Corporation, Orion Pharma
 2013-05 PHASE1
NCT01688089 COMPLETED
Healthy
Orion Corporation, Orion Pharma
 2012-09 PHASE1
NCT01468012 COMPLETED
Cocaine Dependence
New York State Psychiatric Institute
 2014-07 PHASE2; PHASE3
NCT02058966 Completed
Methamphetamine Dependence
Oregon Health and Science University|Portland VA Medical Center
 2014-06 Early Phase 1
NCT01568073 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2011-03 PHASE3
NCT00547911 TERMINATED
Parkinson Disease; Multiple System Atrophy; Autonomic Nervous System Diseases
National Institute of Neurological Disorders and Stroke (NINDS)
 2007-10 PHASE1; PHASE2
NCT01437293 COMPLETED
Cocaine Abuse
New York State Psychiatric Institute
 2010-08 PHASE1
NCT01130493 COMPLETED
Parkinson's Disease
Impax Laboratories, LLC
 2010-05 PHASE3
NCT02170376 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
 2011-09 PHASE1
NCT01296464 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
 2011-02 PHASE2
NCT01070628 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
 2009-12 PHASE1
NCT01519284 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2009-11 PHASE1
NCT00906828 COMPLETED
Parkinson Disease
Uppsala University
 2008-10 PHASE4
NCT00373087 COMPLETED
Parkinson's Disease
Assistance Publique - Hôpitaux de Paris
 2006-10 PHASE4
NCT00601978 WITHDRAWN
Parkinson's Disease
Novartis Pharmaceuticals
 2008-08 PHASE4
NCT00642356 TERMINATED
Parkinson's Disease
Novartis
 2008-03 PHASE4
NCT00125567 COMPLETED
Idiopathic Parkinson's Disease
Orion Corporation, Orion Pharma
 2005-08 PHASE4
NCT00099268 COMPLETED
Parkinson's Disease
Novartis Pharmaceuticals
 2004-09 PHASE3
NCT00219284 COMPLETED
Parkinson's Disease With End of Dose Wearing Off
Novartis Pharmaceuticals
 2005-01 PHASE4
NCT00391898 COMPLETED
Parkinson's Disease
Novartis
 2006-10 PHASE4
NCT00693862 COMPLETED
Pharmacokinetics
Orion Corporation, Orion Pharma
 2006-12 PHASE1
NCT00360308 TERMINATED
Parkinson's Disease
Eisai Limited
 2006-11 PHASE3
NCT00562198 TERMINATED
Parkinson´s Disease
Orion Corporation, Orion Pharma
 2008-01 PHASE2
NCT00491998 COMPLETED
Parkinson's Disease
Vernalis (R&D) Ltd
 2006-11 PHASE1; PHASE2
NCT00547911 Terminated
Parkinson Disease|Multiple System Atrophy|Autonomic Nervous System Diseases
National Institute of Neurological Disorders and Stroke (NINDS)|National Institutes of Health Clinical Center (CC)
 2007-10 Phase 1|Phase 2
NCT00134966 COMPLETED
Parkinson's Disease
Novartis
 2005-08 PHASE3
NCT00237263 COMPLETED
Parkinson's Disease
Novartis
 2003-02 PHASE2
NCT00192855 COMPLETED
Schizophrenia
Rambam Health Care Campus
 2003-06
NCT03094156 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2006-04-26 PHASE1
NCT00415922 Completed
Healthy
Novartis
 2006-07 Phase 1
NCT00143026 COMPLETED
Parkinson's Disease
Novartis
 2005-07 PHASE4
NCT00415831 Completed
Healthy
Novartis
 2006-06 Phase 1
NCT00415844 Completed
Healthy
Novartis
 2006-06 Phase 1
NCT00199394 COMPLETED
Parkinson's Disease
Kyowa Kirin Co., Ltd.
 2004-11 PHASE3
NCT03091868 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2004-11-03 PHASE1
NCT00200447 COMPLETED
Parkinson's Disease
Molecular NeuroImaging
 2004-03 PHASE2
NCT00415922 COMPLETED
Healthy
Novartis
 2006-07 PHASE1
NCT00415844 COMPLETED
Healthy
Novartis
 2006-06 PHASE1
NCT00415831 COMPLETED
Healthy
Novartis
 2006-06 PHASE1
NCT00415740 COMPLETED
Healthy
Novartis
 2006-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-13)

Check the Entacapone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Entacapone selectively inhibits catechol-O-methyltransferase with an IC50 of 151 nM and suppresses FTO demethylation activity at 3.5 μM, thereby preventing the peripheral enzymatic degradation of catecholamines and altering m6A RNA modification dynamics. By blocking peripheral levodopa metabolism, entacapone enhances central dopamine bioavailability, providing direct therapeutic relevance for ameliorating motor fluctuations in Parkinson's disease and addressing metabolic dysfunction.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.