Drugs / Entacapone

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) COMTAN 1999-10-19 fda.gov
Approved EU (EMA) Comtess 1998-09-16 europa.eu

Trials 26 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT04006769 Oct 2020 → Aug 2022 gastrointestinal stromal tumor Xiangya Hospital of Central South University Completed No outcome recorded
Phase 0 NCT02058966 Jun 2014 → Jun 2016 methamphetamine dependence Oregon Health and Science University Completed No outcome recorded
Phase 16 trials
Phase 1 NCT02448914 May → Jul 2015 Parkinson disease LobSor Pharmaceuticals AB Completed No outcome recorded
Phase 1 NCT02096601 Aug 2014 → Mar 2015 Parkinson disease NeuroDerm Ltd. Completed No outcome recorded
Phase 1 NCT02170376 Sep 2011 → Jan 2012 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 1 NCT01437293 Aug 2010 → Apr 2012 cocaine abuse New York State Psychiatric Institute Completed No outcome recorded
Phase 1 NCT01519284 Nov 2009 → Feb 2010 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 1 NCT00693862 Dec 2006 → Apr 2008 Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT02349243 Jan → Sep 2015 obesity disorder Kaichun Wu Unknown No outcome recorded
Phase 1/2 NCT00547911 Oct 2007 → Apr 2013 Parkinson disease, autonomic nervous system disorder, multiple system atrophy National Institute of Neurological Disorders and Stroke (NINDS) Terminated No outcome recorded
Phase 1/2 NCT00262470 Apr 1997 → Dec 2029 expected cardiac rhythm disease Satish R. Raj Active not recruiting No outcome recorded
Phase 24 trials
Phase 2 NCT01883505 Jan 2014 → Apr 2015 Parkinson disease NeuroDerm Ltd. Completed No outcome recorded
Phase 2 NCT00562198 Jan → Feb 2008 Parkinson disease Orion Corporation, Orion Pharma Terminated No outcome recorded
Phase 2 NCT00200447 Mar → Sep 2004 Parkinson disease Molecular NeuroImaging Completed No outcome recorded
Phase 2 NCT00237263 Feb 2003 → Jul 2007 Parkinson disease Novartis Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01468012 Jul 2014 cocaine dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 32 trials
Phase 3 NCT00134966 Aug 2005 → Sep 2007 Parkinson disease Novartis Completed No outcome recorded
Phase 3 NCT00099268 Sep 2004 → Nov 2008 Parkinson disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 47 trials
Phase 4 NCT06236230 Nov 2023 → Jun 2024 Parkinson disease Second Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 4 NCT00906828 Oct 2008 → Nov 2009 Parkinson disease Uppsala University Completed No outcome recorded
Phase 4 NCT00642356 Mar 2008 → May 2009 Parkinson disease Novartis Terminated No outcome recorded
Phase 4 NCT00391898 Oct 2006 → Jun 2008 Parkinson disease Novartis Completed No outcome recorded
Phase 4 NCT00143026 Jul 2005 → Jun 2006 Parkinson disease Novartis Completed No outcome recorded
Phase 4 NCT00219284 Jan 2005 → Jul 2008 Parkinson disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT00247247 Dec 2002 → Jun 2005 Parkinson disease Orion Corporation, Orion Pharma Completed No outcome recorded
Phase not applicable1 trial
NCT00192855 Jun 2003 → Oct 2006 schizophrenia Rambam Health Care Campus Completed No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT04246437 Background Feb 2020 → Feb 2027 expected Lewy body dementia, Parkinson disease, pure autonomic failure Daniel Claassen Recruiting No outcome recorded
Phase 1 NCT02554734 Comparator Aug → Nov 2015 Parkinson disease Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 1 NCT01840423 Comparator May 2013 → Dec 2014 Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 1 NCT01688089 Comparator Sep 2012 → Sep 2014 Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 1 NCT03094156 Background Apr → Jul 2006 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00491998 Comparator Nov 2006 → Nov 2007 Parkinson disease Vernalis (R&D) Ltd Completed No outcome recorded
Phase 25 trials
Phase 2 NCT02764125 Comparator Apr 2016 → Mar 2018 Parkinson disease Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 2 NCT00537017 Background Nov 2007 → Nov 2009 Parkinson disease, movement disorder, neurodegenerative disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00406029 Background Nov 2006 → Oct 2008 Parkinson disease, movement disorder, neurodegenerative disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT03103399 Comparator Sep 2006 → Sep 2007 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 2 NCT02834507 Comparator Mar → Nov 2005 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01568073 Comparator Mar 2011 → Nov 2013 Parkinson disease Bial - Portela C S.A. Completed No outcome recorded
Phase 3 NCT00360308 Comparator Nov 2006 → Apr 2008 Parkinson disease Eisai Inc. Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT00373087 Comparator Oct 2006 → Nov 2009 Parkinson disease Assistance Publique - Hôpitaux de Paris Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 43 sources stand behind the page.

FieldValueCited text
Known as entacapone “Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the...” NCT00406029
38

“Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O...” NCT00537017

“Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks.” NCT00642356

“200 mg of entacapone (Comtan®) in addition to their levodopa/DDCI therapy for the duration of the double-blind (Period 2)” NCT03103399

“TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).” NCT02448914

“Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.” NCT03091868

Entacapone 200 mg tablets \[to be taken orally, with 240 mL of potable water\]” NCT03094156

“4 mg E2007, 200 mg entacapone (with each dose of levodopa) or placebo.” NCT00360308

“levodopa/carbidopa/entacaponeNCT02764125

“Drug: EntacaponeNCT01840423

NCT00906828

NCT01883505

NCT00373087

NCT01568073

NCT02349243

NCT02554734

NCT00237263

NCT04006769

NCT00391898

NCT01519284

NCT00200447

NCT06236230

NCT00219284

NCT00562198

NCT00143026

NCT01688089

NCT00262470

NCT00134966

NCT01468012

NCT02170376

NCT02096601

NCT00192855

NCT01437293

NCT02058966

NCT00547911

NCT00099268

NCT00693862

NCT04246437

NCT00491998

Known as Comtan “200 mg of entacapone (Comtan®) in addition to their levodopa/DDCI therapy for the duration of the double-blind (Period 2)” NCT03103399
2

“Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.” NCT03091868

NCT02834507

Known as Comtess ClinicalTrials.gov intervention name — accepted as the source's own label NCT00247247
Known as Entacapona ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Known as Entacapone component of corbilta ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Known as Entacapone component of stalevo ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Known as Entacapone orion ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Known as Entacapone teva ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Known as OR-611 ChEMBL registry synonym — accepted as the source's own label CHEMBL953
Action Inhibit “entacapone, an inhibitor of catechol-O-methyltransferase” PMID 20582993 Jul 2010
Modality Small molecule CHEMBL953
Route Oral “Entacapone 200-400 mg PO x 1 dose” NCT00262470
Target COMT “inhibiting the C-O-methyltransferase (COMT) enzyme.” NCT00373087