Clinical Trials

Numerous clinical trials evaluate opicapone across Phase 1 through Phase 4, along with pharmacokinetic and bioequivalence assessments, primarily focusing on Parkinson's disease, associated wearing-off motor fluctuations, and related conditions such as epilepsy. Supported by industry sponsors—including Bial - Portela C S.A., Neurocrine Biosciences, and SK Chemicals—and academic institutions like the University Hospital of Ferrara, the majority of these trials are completed, including Phase 1 evaluations of drug-drug interactions and pharmacokinetic profiles. Together, these studies establish the therapeutic utility and safety profile of opicapone as an adjunctive treatment in neurodegenerative disease management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04986982 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2021-02-25 PHASE4
NCT06432309 COMPLETED
Parkinson Disease; Effect of Drug
University Hospital of Ferrara
 2022-07-01
NCT04990284 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2021-11-29 PHASE4
NCT04986995 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2021-06-09 PHASE4
NCT04978597 COMPLETED
Parkinson
Bial - Portela C S.A.
 2021-05-31 PHASE3
NCT04821687 COMPLETED
Parkinson Disease
SK Chemicals Co., Ltd.
 2021-06-17 PHASE4
NCT03820037 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2019-03-19 PHASE1
NCT04265027 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2018-02-20 PHASE1
NCT02847442 COMPLETED
Parkinson's Disease With Wearing-off Motor Fluctuations
Bial - Portela C S.A.
 2016-11-23 PHASE4
NCT03496870 COMPLETED
Parkinson Disease
Neurocrine Biosciences
 2018-02-08 PHASE1
NCT03496870 Completed
Parkinson Disease
Neurocrine Biosciences
 2018-02-08 Phase 1
NCT03116295 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2017-06-20 PHASE1
NCT01851850 COMPLETED
Parkinson Disease
Rabin Medical Center
 2013-05 PHASE3
NCT03116308 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2014-11-21 PHASE1
NCT02305277 COMPLETED
Parkinson
Bial - Portela C S.A.
 2014-03 PHASE1
NCT02305030 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2014-03 PHASE1
NCT02305329 COMPLETED
Epilepsy
Bial - Portela C S.A.
 2014-02 PHASE1
NCT02305017 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2014-03 PHASE1
NCT02305316 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2014-02 PHASE1
NCT02305030 Completed
Parkinson''s Disease
Bial - Portela C S.A.
 2014-03 Phase 1
NCT02305316 Completed
Parkinson Disease
Bial - Portela C S.A.
 2014-02 Phase 1
NCT01520987 Completed
Parkinson Disease
Bial - Portela C S.A.
 2011-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-28)

Check the Opicapone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Opicapone selectively binds to and potently inhibits peripheral catechol-O-methyltransferase (COMT), thereby preventing the peripheral O-methylation and enzymatic degradation of levodopa into 3-O-methyldopa. By increasing levodopa bioavailability and extending its plasma elimination half-life, this peripheral blockade stabilizes central dopamine availability, providing significant clinical benefit in reducing wearing-off motor fluctuations in patients with Parkinson's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.