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Opicapone

Generic Name
Opicapone
Brand Names
Ongentys, Ontilyv
Drug Type
Small Molecule
Chemical Formula
C15H10Cl2N4O6
CAS Number
923287-50-7
Unique Ingredient Identifier
Y5929UIJ5N
Background

Opicapone is a potent, reversible, and peripherally-acting third-generation inhibitor of catechol-o-methyltransferase (COMT), an enzyme involved in the breakdown of various catecholamines including dopamine. Many patients with Parkinson’s disease treated with levodopa plus a dopa decarboxylase (DDC) inhibitor (eg carbidopa) experience motor complications over time, which calls for the management of these symptoms through the use of a dopamine agonist, a monoamine oxidase B inhibitor (selegiline, rasagiline), a catechol-O-methyl transferase (COMT) inhibitor, or amantadine, or using a modified-release formulation of levodopa.

Opicapone is used for adjunct therapy to levodopa and carbidopa in adult patients with Parkinson's disease and end-of-dose motor fluctuations. Opicapone was approved for use by the European Commission in June 2016 and the FDA in April 2020. It is marketed under the brand name Ongentys as once-daily oral capsules. Exhibiting a long duration of action that exceeds 24 hours, opicapone can be administered once-daily and demonstrates the lowest risk for cytotoxicity compared to other catechol-O-methyltransferase inhibitors.

Indication

Opicapone is indicated as adjunctive therapy in adults with Parkinson’s disease and end-of-dose motor fluctuations or “off” episodes whose symptoms cannot be stabilized on the combination therapy of levodopa and DOPA decarboxylase inhibitor (e.g., carbidopa).

Associated Conditions
Parkinson's Disease (PD)

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2018-04-12
Last Posted Date
2019-03-22
Lead Sponsor
Neurocrine Biosciences
Target Recruit Count
16
Registration Number
NCT03496870
Locations
🇺🇸

Neurocrine Clinical Site, Farmington Hills, Michigan, United States

Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2017-04-17
Last Posted Date
2018-10-15
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
56
Registration Number
NCT03116295
Locations
🇩🇪

Nuvisan GmbH, Neu-Ulm, Germany

Effect of Food on Opicapone

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2017-04-17
Last Posted Date
2017-04-17
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
28
Registration Number
NCT03116308

Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Phase 3
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2013-05-13
Last Posted Date
2020-03-16
Lead Sponsor
Rabin Medical Center
Target Recruit Count
1
Registration Number
NCT01851850
Locations
🇮🇱

Rabin Medical Center, Petach Tiqva, Hamerkaz, Israel

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