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Drug

Opicapone

Approved · EMA
Late-stage development

Also known as Ongentys, Opicapona.

RxNorm2362167ChEMBLCHEMBL1089318UNIIY5929UIJ5N
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain.

Clinical trial2025-03-28Results posted · ClinicalTrials.gov

Market withdrawal: Ontilyv (EMA)

Regulatory2025-02-21EMA

Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel

Clinical trial2024-04-25Completed · ClinicalTrials.gov

A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension

Clinical trial2024-01-26Completed · ClinicalTrials.gov

A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.

Clinical trial2023-04-04Completed · ClinicalTrials.gov

Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders

Clinical trial2023-03-29Completed · ClinicalTrials.gov

A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease

Clinical trial2022-08-18Completed · ClinicalTrials.gov

A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects

Clinical trial2019-06-09Completed · ClinicalTrials.gov

An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers.

Clinical trial2018-07-24Completed · ClinicalTrials.gov

A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease

Clinical trial2018-07-02Completed · ClinicalTrials.gov

A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects

Clinical trial2017-08-28Completed · ClinicalTrials.gov

Approval: Ongentys (EMA)

Regulatory2016-06-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Opicapone
Aliases & brands
OngentysOpicapona
RxNorm CUI
2362167
ChEMBL ID
CHEMBL1089318
UNII
Y5929UIJ5N
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-06-24
Latest approval
2016-06-24
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2025-02-21Market withdrawalMarket
Market withdrawal: Ontilyv (EMA)
Indication: Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor… Show full indication

Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Evidence ↗
2016-06-24Approval
Approval: Ongentys (EMA)
Indication: Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor… Show full indication

Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2024
7
Late-stage (III+)
12
Completed
PHASE DISTRIBUTIONn = 12
Phase 15Phase 32Phase 44Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain.

CompletedPH IVBial - Portela C S.A.n=1442024

A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.

CompletedPH IVBial - Portela C S.A.n=1062023

Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders

CompletedPH IVBial - Portela C S.A.n=222023

A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease

CompletedPH IVSK Chemicals Co., Ltd.n=1692022

A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension

CompletedPH IIIBial - Portela C S.A.n=4102024

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy and Safety of Opicapone in Parkinson's Disease Add -on to Levodopa Carbidopa Intestinal Gel

CompletedN/AUniversity Hospital of Ferraran=222024

Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain.

CompletedPH IVBial - Portela C S.A.n=1442024

A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension

CompletedPH IIIBial - Portela C S.A.n=4102024

A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.

CompletedPH IVBial - Portela C S.A.n=1062023

Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders

CompletedPH IVBial - Portela C S.A.n=222023

A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease

CompletedPH IVSK Chemicals Co., Ltd.n=1692022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.