Entacapone

Overview

Entacapone is a selective, reversible catechol-O-methyl transferase (COMT) inhibitor for the treatment of Parkinson's disease. It is a member of the class of nitrocatechols. When administered concomittantly with levodopa and a decarboxylase inhibitor (e.g., carbidopa), increased and more sustained plasma levodopa concentrations are reached as compared to the administration of levodopa and a decarboxylase inhibitor.

Indication

Used as an adjunct to levodopa / carbidopa in the symptomatic treatment of patients with idiopathic Parkinson's Disease who experience the signs and symptoms of end-of-dose "wearing-off".

Associated Conditions

Parkinson's Disease (PD)
Wearing Off Effect

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
[18F]F-DOPA Imaging in Patients With Autonomic Failure	2020/01/29	NCT04246437	Phase 1	Recruiting	Daniel Claassen
Entacapone Combination With Imatinib for Treatment of GIST	2019/07/05	NCT04006769	Early Phase 1	Completed	Xiangya Hospital of Central South University
Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon	2017/04/06	NCT03103399	Phase 2	Completed	Bial - Portela C S.A.
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics	2017/03/29	NCT03094156	Phase 1	Completed	Bial - Portela C S.A.
Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics	2017/03/27	NCT03091868	Phase 1	Completed	Bial - Portela C S.A.
Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients	2016/07/15	NCT02834507	Phase 2	Completed	Bial - Portela C S.A.
Pharmacokinetic Study in Healthy Volunteers	2015/09/18	NCT02554734	Phase 1	Completed	Orion Corporation, Orion Pharma
Effect of Entacapone on Bodyweight Loss in Obese Population	2015/01/28	NCT02349243	Phase 1	UNKNOWN	Kaichun Wu
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics	2014/06/23	NCT02170376	Phase 1	Completed	Bial - Portela C S.A.
A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients	2014/03/26	NCT02096601	Phase 1	Completed	NeuroDerm Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CARBIDOPA, LEVODOPA AND ENTACAPONE	Rising Pharma Holdings, Inc.	16571-691	ORAL	200 mg in 1 1	2/1/2022
Entacapone	Macleods Pharmaceuticals Limited	33342-260	ORAL	200 mg in 1 1	12/25/2023
Entacapone	Wockhardt USA LLC.	64679-781	ORAL	200 mg in 1 1	12/24/2020
Stalevo	Almatica Pharma LLC	52427-842	ORAL	200 mg in 1 1	12/31/2019
Carbidopa, levodopa and entacapone	Sun Pharmaceutical Industries, Inc.	47335-001	ORAL	200 mg in 1 1	3/1/2019
Carbidopa, levodopa and entacapone	Sun Pharmaceutical Industries, Inc.	47335-005	ORAL	200 mg in 1 1	3/1/2019
Carbidopa, Levodopa, and Entacapone	Sandoz Inc	0781-5637	ORAL	200 mg in 1 1	2/1/2016
Stalevo	Almatica Pharma LLC	52427-827	ORAL	200 mg in 1 1	12/31/2019
Entacapone	Aurobindo Pharma Limited	65862-654	ORAL	200 mg in 1 1	6/21/2023
Stalevo	Almatica Pharma LLC	52427-805	ORAL	200 mg in 1 1	12/31/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	Orion Corporation,Orionintie 1,02 200 Espoo,Finland	Authorised	11/11/2013
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)	Orion Corporation,Orionintie 1,02 200 Espoo,Finland	Authorised	11/11/2013
Stalevo	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	10/17/2003
Levodopa/Carbidopa/Entacapone Orion	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	8/23/2011
Comtan	Orion Corporation,Orionintie 1,FIN-02200 Espoo,Finland	Authorised	9/22/1998
Entacapone Teva	Teva Pharma B.V.,Computerweg 10,NL-3542 DR Utrecht,The Netherlands	Authorised	2/18/2011
Entacapone Orion	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	8/18/2011
Comtess	Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland	Authorised	9/16/1998

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ENCAPIA FILM COATED TABLETS 200MG	MEDOCHEMIE LTD - CENTRAL FACTORY, MEDOCHEMIE LTD - FACTORY AZ (Primary & Secondary Packager)	SIN16544P	TABLET, FILM COATED	200.0mg	7/6/2022
COMTAN TABLET 200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN11234P	TABLET, FILM COATED	200 mg	11/29/1999
Stalevo Film Coated Tablets 100/25/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13142P	TABLET, FILM COATED	200 mg	8/29/2005
Stalevo Film Coated Tablets 150/37.5/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13141P	TABLET, FILM COATED	200 mg	8/29/2005
Stalevo Film Coated Tablets 50/12.5/200 mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13143P	TABLET, FILM COATED	200 mg	8/29/2005
ANTIPAR FILM COATED TABLET 100 mg/25 mg/200 mg	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16956P	TABLET, FILM COATED	200.000mg	2/20/2024
ANTIPAR FILM COATED TABLET 150 mg/37.5 mg/200 mg	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16957P	TABLET, FILM COATED	200.000mg	2/20/2024
Stalevo Film Coated Tablet 200/50/200mg	Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)	SIN13566P	TABLET, FILM COATED	200mg	11/3/2008

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
L.C.E. SANDOZ 125/31.25/200 levodopa 125 mg, carbidopa (as carbidopa monohydrate) 31.25 mg and entacapone 200 mg film-coated tablet bottle	192175	Sandoz Pty Ltd	Medicine	A	11/14/2013
LECTEVA levodopa/carbidopa/entacapone 200 mg/50 mg/200 mg tablet bottle	238866	Teva Pharma Australia Pty Ltd	Medicine	A	4/7/2016
STALEVO 150/37.5/200 levodopa/carbidopa (as monohydrate)/entacapone tablet bottle	96396	Sandoz Pty Ltd	Medicine	A	10/5/2004
CARLEVENT levodopa/carbidopa/entacapone 150/37.5/200 mg tablet bottle	195749	Medis Pharma Pty Ltd	Medicine	A	10/3/2013
LECTEVA levodopa/carbidopa/entacapone 75 mg/18.75 mg/200 mg tablet bottle	238861	Teva Pharma Australia Pty Ltd	Medicine	A	4/7/2016
L.C.E. SANDOZ 150/37.5/200 levodopa 150 mg, carbidopa (as carbidopa monohydrate) 37.5 mg and entacapone 200 mg film-coated tablet bottle	192176	Sandoz Pty Ltd	Medicine	A	11/14/2013
L.C.E. SANDOZ 50/12.5/200 levodopa 50 mg, carbidopa (as carbidopa monohydrate) 12.5 mg and entacapone 200 mg film-coated tablet bottle	192172	Sandoz Pty Ltd	Medicine	A	11/14/2013
LECTEVA levodopa/carbidopa/entacapone 100 mg/25 mg/200 mg tablet bottle	238862	Teva Pharma Australia Pty Ltd	Medicine	A	4/7/2016
L.C.E. SANDOZ 200/50/200 levodopa 200 mg, carbidopa (as carbidopa monohydrate) 50 mg and entacapone 200 mg film-coated tablet bottle	192177	Sandoz Pty Ltd	Medicine	A	11/14/2013
CARLEVENT levodopa/carbidopa/entacapone 50/12.5/200 mg tablet bottle	195198	Medis Pharma Pty Ltd	Medicine	A	10/3/2013

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AURO-ENTACAPONE	auro pharma inc	02431602	Tablet - Oral	200 MG	N/A
SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE	Sandoz Canada, Inc.	02498871	Tablet - Oral	200 MG	N/A
SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE	Sandoz Canada, Inc.	02498855	Tablet - Oral	200 MG	N/A
MYLAN-ENTACAPONE	Mylan Pharmaceuticals ULC	02390337	Tablet - Oral	200 MG	7/31/2012
STALEVO	Sandoz Canada, Inc.	02305933	Tablet - Oral	200 MG	4/28/2008
APO-ENTACAPONE	Apotex Inc	02321459	Tablet - Oral	200 MG	N/A
LEVODOPA, CARBIDOPA AND ENTACAPONE TABLETS	Strides Pharma Canada Inc	02517884	Tablet - Oral	200 MG	N/A
SANDOZ LEVODOPA-CARBIDOPA-ENTACAPONE	Sandoz Canada, Inc.	02498898	Tablet - Oral	200 MG	N/A
STALEVO	Sandoz Canada, Inc.	02305968	Tablet - Oral	200 MG	4/28/2008
STALEVO	Sandoz Canada, Inc.	02337827	Tablet - Oral	200 MG	1/20/2010

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
STALEVO 50 mg/12,5 mg/200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Orion Corporation	03260003	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA KERN PHARMA 50 mg /12,5 mg /200 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Kern Pharma S.L.	79655	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA KERN PHARMA 75 mg /18,75 mg /200 mg COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Kern Pharma S.L.	79656	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
STALEVO 100 mg/25 mg/200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Orion Corporation	03260007	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA TECNIGEN 150 MG/37,5 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tecnimede España Industria Farmaceutica S.A.	79842	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LEVODOPA/CARBIDOPA ENTACAPONA MYLAN 75 MG/18,75 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Mylan Pharmaceuticals S.L.	80690	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA AUROVITAS SPAIN 125 MG/31,25 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aurovitas Spain, S.A.U.	79275	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA STADA 200 MG/50 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	78995	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
LEVODOPA/CARBIDOPA/ENTACAPONA AUROVITAS SPAIN 200 MG/50 MG/200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aurovitas Spain, S.A.U.	79278	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
STALEVO 100 mg/25 mg/200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Orion Corporation	03260008	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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