Tolcapone

Overview

Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase (COMT). It is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication. It is a yellow, odorless, non-hygroscopic, crystalline compound. Tolcapone is associated with a risk of hepatotoxicity.

Indication

Used as an adjunct to levodopa/carbidopa therapy for the symptomatic treatment of Parkinson's Disease. This drug is generally reserved for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies.

Associated Conditions

Idiopathic Parkinson's Disease

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia	2024/04/29	NCT06387771	Phase 2	Recruiting	Clinica Universidad de Navarra, Universidad de Navarra
A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder	2022/11/22	NCT05624528	Phase 2	Recruiting	University of Chicago
Microbiome Derived Metabolism and Pharmacokinetics	2021/10/04	NCT05065671	Phase 1	Recruiting	Rutgers, The State University of New Jersey
Dopaminergic Mechanisms Underlying Human Social Behavior	2019/12/20	NCT04205994	Early Phase 1	Completed	University of California, Berkeley
COMT Inhibition Among Individuals With Comorbid AUD/ADHD	2019/04/05	NCT03904498	Phase 2	Recruiting	University of Colorado, Denver
A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone	2018/08/16	NCT03633591	Phase 1	Completed	Corino Therapeutics, Inc.
Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)	2018/07/19	NCT03591757	Early Phase 1	Completed	Boston University
Tolcapone in Obsessive Compulsive Disorder	2017/11/21	NCT03348930	Phase 2	Completed	University of Chicago
A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury	2017/09/06	NCT03273062	Phase 2	UNKNOWN	Sheppard Pratt Health System
Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control	2016/10/31	NCT02949934	Phase 2	Completed	Medical University of South Carolina

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tasmar	Bausch Health US LLC	0187-0938	ORAL	100 mg in 1 1	10/2/2020
TOLCAPONE	Ingenus Pharmaceuticals, LLC	50742-193	ORAL	100 mg in 1 1	11/28/2018
Tolcapone	Oceanside Pharmaceuticals	68682-938	ORAL	100 mg in 1 1	10/1/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Tasmar	Viatris Healthcare Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Dublin,Ireland	Authorised	8/27/1997

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TASMAR	Hoffmann-La Roche Limited	02235914	Tablet - Oral	100 MG / TAB	10/20/1997
TASMAR	Hoffmann-La Roche Limited	02235921	Tablet - Oral	200 MG / TAB	10/20/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TASMAR 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Viatris Healthcare Limited	97044003	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
TASMAR 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Viatris Healthcare Limited	97044006	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	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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