Drugs / Tolcapone

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TASMAR — 1998-01-29 fda.gov ↗
Approved EU (EMA) Tasmar — 1997-08-27 europa.eu ↗

Trials 19

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials · 1 met primary
Phase 0 NCT04205994 Dec 2019 → Dec 2023 — University of California, Berkeley Completed No outcome recorded
Phase 0 NCT03591757 Oct 2018 → Apr 2019 hereditary amyloidosis Boston University Completed No outcome recorded
Phase 0 NCT02260570 Aug 2015 → Jun 2021 traumatic brain injury VA Office of Research and Development Completed Met primary
Phase 15 trials
Phase 1 NCT05065671 Feb 2022 → Sep 2025 — Rutgers, The State University of New Jersey Completed No outcome recorded
Phase 1 NCT03633591 Jun → Oct 2018 — Corino Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02630043 Dec 2015 → Jul 2019 neuroblastoma Giselle Sholler Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02080715 Jun 2013 → Apr 2014 — University of Zurich Completed No outcome recorded
Phase 1 NCT00033059 Jul 2001 → Mar 2002 substance-related disorder National Institute on Drug Abuse (NIDA) Unknown No outcome recorded
Phase 27 trials
Phase 2 NCT05624528 Jun 2023 → Jun 2026 obsessive-compulsive disorder University of Chicago Completed No outcome recorded
Phase 2 NCT03904498 Aug 2021 → Mar 2026 alcohol-related disorders, attention deficit-hyperactivity disorder University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT02740582 Oct 2016 → Sep 2019 alcohol abuse, impulse control disorder Jennifer Mitchell Completed No outcome recorded
Phase 2 NCT02652598 Nov 2015 → Jan 2020 cognitive disorder, traumatic brain injury Sheppard Pratt Health System Unknown No outcome recorded
Phase 2 NCT06387771 Sep 2014 → Aug 2025 schizophrenia Clinica Universidad de Navarra, Universidad de Navarra Unknown No outcome recorded
Phase 2 NCT00927563 Jun 2009 → May 2012 pathological gambling University of Chicago Completed No outcome recorded
Phase 2 NCT00604591 Jan 2008 → Jun 2016 frontotemporal dementia Columbia University Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03348930 Mar 2018 → Dec 2020 obsessive-compulsive disorder University of Chicago Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02929485 Jul 2013 → Jan 2018 substance dependence University of California, Berkeley Withdrawn No outcome recorded
Phase 4 NCT00906828 Oct 2008 → Nov 2009 Parkinson disease Uppsala University Completed No outcome recorded
Phase not applicable1 trial
— NCT01158950 Mar 2010 → Dec 2018 impulse control disorder University of California, San Francisco Completed No outcome recorded
Comparator or background therapy7 trials
Phase 2 NCT03273062 Comparator Jul 2017 → Jul 2018 traumatic brain injury Sheppard Pratt Health System Unknown No outcome recorded
Phase 2 NCT02949934 Comparator May 2016 → Apr 2021 alcohol-related disorders Medical University of South Carolina Completed No outcome recorded
Phase 2 NCT01001520 Comparator Jan 2010 → Oct 2012 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT01202955 Comparator Jul 2008 → May 2009 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT00044083 Comparator Aug 2002 → Dec 2015 schizophrenia National Institute of Mental Health (NIMH) Terminated No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Tolcapone ClinicalTrials.gov intervention name — accepted as the source's own label NCT00044083 ↗
25

NCT01202955 ↗

NCT03591757 ↗

NCT00906828 ↗

NCT05065671 ↗

NCT01158950 ↗

NCT00033059 ↗

NCT03348930 ↗

NCT02652598 ↗

NCT00604591 ↗

NCT02740582 ↗

Show 15 more sources

Action Inhibit “pharmacological reduction of COMT activity” PMID 23794107 ↗ Aug 2013
Route Oral “tolcapone (Tasmar, tablets, 100 mg three times a day for 1 day and then 200 mg three times a day for 6 days; ClinicalTrials.gov identifier: NCT00044083)” PMID 23794107 ↗ Aug 2013
Target COMT “tolcapone, a CNS penetrant COMT inhibitor that increases cortical dopamine levels” PMID 23794107 ↗ Aug 2013