Tasmar

(Tolcapone)

ApprovedSmall molecule

Tolcapone is used to treat Parkinson's disease by helping to extend the effects of another Parkinson's medication called levodopa, making it work longer and more effectively.[2] Tasmar is currently approved and in use across 14 indications[4].[1]

Tasmar is one of 176 small molecule programs targeting Alcohol Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

175

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Alcohol DependenceApproved

Nicotine DependenceApproved

Gambling BehaviourApproved

Pick DiseaseApproved

Executive FunctionApproved

Alcohol AbuseApproved

ConcussionApproved

Familial Amyloid NeuropathyApproved

Hepatic FailureActive, not recruiting

Parkinson DiseaseActive, not recruiting

Alcohol DependenceApproved

Approved

Nicotine DependenceApproved

Approved

Gambling BehaviourApproved

Approved

Pick DiseaseApproved

Approved

Executive FunctionApproved

Approved

Alcohol AbuseApproved

Approved

ConcussionApproved

Approved

Familial Amyloid NeuropathyApproved

Approved

Hepatic FailureApproved

Active, not recruiting

Parkinson DiseaseApproved

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

92 competitors in Parkinson Disease

#DrugCompanyPhaseTrials

Tasmar

BBausch Health Americas, Inc.

Approved

26 2

Exelon

Novartis

Approved

1 3

Northera

Lundbeck

Approved

1 4

Myrbetriq

Astellas

Approved

1 5

Medrol

Pfizer

Approved

1 6

Brintellix

Takeda

Approved

1 7

Golytely

Buspar

Cymbalta

Intropin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Obsessive-Compulsive Disorder2 trials

A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT05624528·49 enrolled

Tolcapone in Obsessive Compulsive Disorder

Completed·UUniversity of Chicago·Phase 2/3·NCT03348930·20 enrolled

Schizophrenia2 trials

Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia

Unknown status·—·Phase 2·NCT06387771·20 enrolled

Clinical Trial of Tolcapone for Cognition in Schizophrenia

Terminated·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00044083·210 enrolled

Function2 trials

Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD

Unknown status·SSheppard Pratt Health System·Phase 2·NCT02652598·100 enrolled

Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor

Withdrawn·UUniversity of California, Berkeley·Phase 4·NCT02929485

Craving1 trial

Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control

Completed·MMedical University of South Carolina·Phase 2·NCT02949934·90 enrolled

ILD1 trial

Remediation of Impaired Self-Regulation in Patients With Mild TBI

Completed·VVA Office of Research and Development·Phase 1·NCT02260570·55 enrolled

16 more indications

Treatment1 trial

Treatment for Nicotine Addiction in Women

Completed·YYale University·N/A·NCT02448654·36 enrolled

Pathological Gambling1 trial

Tolcapone Treatment of Pathological Gambling

Completed·UUniversity of Chicago·Phase 2·NCT00927563·24 enrolled

ADHD1 trial

COMT Inhibition Among Individuals With Comorbid AUD/ADHD

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT03904498·62 enrolled

ESS1 trial

A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

Completed·CCorino Therapeutics, Inc.·Phase 1·NCT03633591·12 enrolled

Nicotine Withdrawal1 trial

Neural Substrates in Nicotine Withdrawal

Completed·UUniversity of Pennsylvania·Phase 2·NCT01001520·218 enrolled

Infusion1 trial

Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors

Completed·UUppsala University·Phase 4·NCT00906828·10 enrolled

Amyloidosis1 trial

Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)

Completed·—·Phase 1·NCT03591757·10 enrolled

Neuroblastoma1 trial

Trial of Tolcapone With Oxaliplatin for Neuroblastoma

Terminated·GGiselle Sholler·Phase 1·NCT02630043·5 enrolled

Social Behavior1 trial

Dopaminergic Mechanisms Underlying Human Social Behavior

Completed·UUniversity of California, Berkeley·Phase 1·NCT04205994·70 enrolled

Brain Injury1 trial

A Trial Evaluating Effects of COMT Inhibition in Patients With Acquired Brain Injury

Unknown status·SSheppard Pratt Health System·Phase 2·NCT03273062·16 enrolled

Metabolism1 trial

Microbiome Derived Metabolism and Pharmacokinetics

Recruiting·RRutgers, The State University of New Jersey·Phase 1·NCT05065671·14 enrolled

Interaction1 trial

Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00033059·16 enrolled

Frontotemporal Dementia1 trial

Effects of Tolcapone on Frontotemporal Dementia

Completed·—·Phase 2·NCT00604591·28 enrolled

Alcohol Use1 trial

Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users

Completed·JJennifer Mitchell·Phase 2·NCT02740582·62 enrolled

Pilot Study1 trial

Pilot Study of Tolcapone in Smokers

Completed·UUniversity of Pennsylvania·Phase 2·NCT01202955·19 enrolled

Unspecified3 trials

Dopamine Responsivity in Gamblers

Completed·UUniversity of California, San Francisco·N/A·NCT02772978·19 enrolled

Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance

Completed·UUniversity of Zurich·Phase 1·NCT02080715·30 enrolled

A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors

Completed·UUniversity of California, San Francisco·N/A·NCT01158950·26 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 29, 1998

TASMAR

NDA NDA020697

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Tolcapone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tasmar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tolcapone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tolcapone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020697). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Catechol O-Methyltransferase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Tasmar

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Obsessive-Compulsive Disorder2 trials

Schizophrenia2 trials

Function2 trials

Craving1 trial

ILD1 trial

Treatment1 trial

Pathological Gambling1 trial

ADHD1 trial

ESS1 trial

Nicotine Withdrawal1 trial

Infusion1 trial

Amyloidosis1 trial

Neuroblastoma1 trial

Social Behavior1 trial

Brain Injury1 trial

Metabolism1 trial

Interaction1 trial

Frontotemporal Dementia1 trial

Alcohol Use1 trial

Pilot Study1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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