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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)

Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Not Applicable
Completed
Conditions
Effect of Drug
Parkinson Disease
Interventions
First Posted Date
2024-05-29
Last Posted Date
2025-03-03
Lead Sponsor
University Hospital of Ferrara
Target Recruit Count
22
Registration Number
NCT06432309
Locations
🇮🇹

University Hospital of Ferrara - Arcispedale Sant'Anna, Ferrara, Emilia Romagna, Italy

eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
Drug: L-DOPA/DDCI
First Posted Date
2021-08-04
Last Posted Date
2025-03-12
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
106
Registration Number
NCT04990284
Locations
🇵🇹

Hospital Beatriz Ângelo, Loures, Lisboa, Portugal

🇮🇹

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milano, Italy

🇮🇹

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli", Napoli, Italy

and more 22 locations

OpiCapone Effect on Motor Fluctuations and pAiN

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
Other: Placebo
First Posted Date
2021-08-03
Last Posted Date
2025-03-28
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
144
Registration Number
NCT04986982
Locations
🇬🇧

The Maurice Wohl Clinical Neuroscience Institute - King's College Hospital, London, United Kingdom

OpicApone Sleep dISorder

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2021-08-03
Last Posted Date
2025-03-12
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
22
Registration Number
NCT04986995
Locations
🇵🇹

Hospital da Senhora da Oliveira - Guimarães, E.P.E, Serviço de Neurologia, Guimarães, Portugal

Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)

Phase 3
Completed
Conditions
Parkinson
Interventions
First Posted Date
2021-07-27
Last Posted Date
2025-03-12
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
410
Registration Number
NCT04978597
Locations
🇧🇬

Medical Centre "Asklepii", OOD, Dupnitsa, Bulgaria

A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg
First Posted Date
2021-03-29
Last Posted Date
2023-06-01
Lead Sponsor
SK Chemicals Co., Ltd.
Target Recruit Count
169
Registration Number
NCT04821687
Locations
🇰🇷

Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, Korea, Republic of

Opicapone Treatment Initiation Open-Label Study

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2021-03-09
Last Posted Date
2022-11-28
Lead Sponsor
Neurocrine Biosciences
Target Recruit Count
239
Registration Number
NCT04787965
Locations
🇺🇸

Neurocrine clinical site, Crab Orchard, West Virginia, United States

Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
Drug: 50 mg BIA 9 1067
Drug: 25 mg BIA9 1067
First Posted Date
2020-02-11
Last Posted Date
2020-02-11
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
72
Registration Number
NCT04265027
Locations
🇬🇧

Simbec Research Ltd, Merthyr Tydfil, United Kingdom

Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2019-05-22
Last Posted Date
2021-10-04
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
39
Registration Number
NCT03959540
Locations
🇬🇧

Norfolk&Norwich University Hospitals, Norwich, Norfolk, United Kingdom

Relative Bioavailability and Bioequivalence of Opicapone

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2019-01-29
Last Posted Date
2020-12-31
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
45
Registration Number
NCT03820037
Locations
🇬🇧

Covance Clinical Research, Leeds, United Kingdom

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