Entacapone
Small molecule targets COMT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT03091868 Background | Nov 2004 → Feb 2005 | 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.
| Field | Value | Cited 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/entacapone” NCT02764125 ↗ “Drug: Entacapone” NCT01840423 ↗ |
| 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 ↗ |
| 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 ↗ |