Drugs / Entacapone
Entacapone
also known as
Comtan · Comtess · Entacapona · Entacapone component of corbilta · Entacapone component of stalevo · Entacapone orion · Entacapone teva · OR-611
Small molecule targets COMT, MYOF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn Parkinson disease 1 milestone | |||||
| Withdrawn | US (FDA) | Stalevo | Parkinson disease | 2009-10-21 | “withdrawn the US application for extending the current US indication of its proprietary drug Stalevo® (levodopa, carbidopa and entacapone) to patients with early Parkinson's disease.” orionpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | COMTAN | — | 1999-10-19 | fda.gov ↗ |
| Approved | EU (EMA) | Comtess | — | 1998-09-16 | europa.eu ↗ |
Trials 27
| 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 · 1 met primary | ||||||
| Phase 1 | NCT02448914 | May → Jul 2015 | Parkinson disease | LobSor Pharmaceuticals AB | Completed | Met primary |
| 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 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT07831187 | Oct 2026 → Sep 2029 expected | glioblastoma | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| 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 | Missed primary |
| 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 · 1 met primary | ||||||
| Phase 3 | NCT00134966 | Aug 2005 → Sep 2007 | Parkinson disease | Novartis | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 |
| Comparator or background therapy15 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 1/2 | NCT00491998 Comparator | Nov 2006 → Nov 2007 | Parkinson disease | Vernalis (R&D) Ltd | Completed | No outcome recorded |
| Phase 2 | NCT02764125 Comparator | Apr 2016 → Mar 2018 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | Met primary |
| 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 | Met primary |
| 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 3 | NCT01568073 Comparator | Mar 2011 → Nov 2013 | Parkinson disease | Bial - Portela C S.A. | Completed | Met primary |
| Phase 3 | NCT00360308 Comparator | Nov 2006 → Apr 2008 | Parkinson disease | Eisai Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00373087 Comparator | Oct 2006 → Nov 2009 | Parkinson disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2022-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory 5th January, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg. |
| 2020-09-17 | LobSor Pharmaceuticals AB | Regulatory Lobsor Pharmaceuticals receive approval for Lecigon in Germany, the Netherlands, Belgium, Austria, Slovenia and Romania lobsor.com ↗
Lobsor Pharmaceuticals receive approval for Lecigon in Germany, the Netherlands, Belgium, Austria, Slovenia and Romania |
| 2019-10-01 | LobSor Pharmaceuticals AB | Regulatory Lobsor Pharmaceuticals receive approval for Lecigon® in Denmark, Finland and Norway lobsor.com ↗
Lobsor Pharmaceuticals AB today announced that Lecigon has been approved, and that the Swedish Medical Products Agency (MPA) has confirmed End of Procedure according to the European Mutual Recognition Procedure (MRP) including Denmark, Finland and Norway. |
| 2012-08-20 | Wockhardt | Regulatory WOCKHARDT RECEIVES US FDA APPROVAL FOR GENERIC VERSION OF PARKINSON’S DRUG COMTAN® wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received US FDA approval for marketing a generic version of 200mg tablets containing Entacapone, which is used in the treatment of Parkinson’s disease. |
| 2010-12-15 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Comtan® (entacapone) in the United States orionpharma.com ↗
Mylan has filed so-called Paragraph IV certifications challenging Orion U.S. patent No. 5,446,194 and U.S. Patent No. 6,599,530 covering Comtan and listed in the Orange Book, the FDA's official listing of approved drug products. |
| 2008-11-03 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗
At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent. |
| 2008-10-28 | Orion Corporation, Orion Pharma | Regulatory Orion Group Interim Report 1-9/2008 orionpharma.com ↗
In October, Orion Corporation was informed that Sun Pharma Global, Inc. has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. |
| 2008-10-07 | Orion Corporation, Orion Pharma | Regulatory Orion comments on new ANDA by Sun Pharma Global, Inc. for generic entacapone (Orion's proprietary drug Comtan®) in the United States orionpharma.com ↗
Sun Pharma Global's new ANDA challenges two of Orion's U.S. patents listed in the FDA's Orange Book, U.S. Patent Nos. 5,446,194 (already part of the New Jersey lawsuit) and 6,599,530. |
| 2007-08-13 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filing of generic entacapone (Orion's proprietary drug Comtan®) in the United States orionpharma.com ↗
Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed with the U.S. Food and Drug Administration (FDA) by a generic drug company seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. |
| 2002-09-23 | Orion Corporation, Orion Pharma | Regulatory Combination tablet for Parkinson's disease now filed also in Europe by Orion Pharma orionpharma.com ↗
The new drug application by Orion Pharma for a triple combination tablet for Parkinson's disease is under review by the European Agency for the Evaluation of Medicinal Products (EMEA), the pharmaceutical regulatory authority for the EU countries. |
All press releases naming this drug 17 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 44 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 ↗39“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 ↗ |