MedPath

Entacapone

Generic Name
Entacapone
Brand Names
Comtan, Comtess, Stalevo, Entacapone Orion, Entacapone Teva
Drug Type
Small Molecule
Chemical Formula
C14H15N3O5
CAS Number
130929-57-6
Unique Ingredient Identifier
4975G9NM6T

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.

Background

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

Phase 1
Recruiting
Posted: 2020/01/29
Sponsor:
Daniel Claassen
Early Phase 1
Completed
Posted: 2019/07/05
Sponsor:
Xiangya Hospital of ...
Phase 1
Completed
Posted: 2017/03/29
Sponsor:
Bial - Portela C S.A...

FDA Approved Products

Comtan
Manufacturer:Almatica Pharma LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2018/06/14
NDC:52427-800
Entacapone
Manufacturer:Lannett Company, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/10/07
NDC:0527-1830
Entacapone
Manufacturer:Wockhardt USA LLC.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2021/12/29
NDC:64679-711
Entacapone
Manufacturer:Sun Pharmaceutical Industries, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2018/10/25
NDC:47335-007
CARBIDOPA, LEVODOPA AND ENTACAPONE
Manufacturer:Rising Pharma Holdings, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2022/02/01
NDC:16571-689

Singapore Approved Products

ENCAPIA FILM COATED TABLETS 200MG
Manufacturer:MEDOCHEMIE LTD - CENTRAL FACTORY, MEDOCHEMIE LTD - FACTORY AZ (Primary & Secondary Packager)
Form:TABLET, FILM COATED
Strength:200.0mg
Online:Yes
Approved: 2022/07/06
Approval:SIN16544P
COMTAN TABLET 200 mg
Manufacturer:Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:200 mg
Online:Yes
Approved: 1999/11/29
Approval:SIN11234P
Stalevo Film Coated Tablets 100/25/200 mg
Manufacturer:Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:200 mg
Online:Yes
Approved: 2005/08/29
Approval:SIN13142P
Stalevo Film Coated Tablets 150/37.5/200 mg
Manufacturer:Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:200 mg
Online:Yes
Approved: 2005/08/29
Approval:SIN13141P
Stalevo Film Coated Tablets 50/12.5/200 mg
Manufacturer:Orion Corporation, Orion Pharma, Orion Corporation, Orion Pharma (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:200 mg
Online:Yes
Approved: 2005/08/29
Approval:SIN13143P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath