Ongentys (opicapone) / Fosun Pharma, Ono Pharmaceutical, Neurocrine Biosciences, SK Bio, BIAL - LARVOL DELTA

Opicapone as adjunct to levodopa in Chinese patients with Parkinson’s disease and wearing-off: a randomized, double-blind, placebo-controlled phase 3 trial (MDS Congress 2026) - No abstract available

Clinical • P3 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Patient self-rated Improvements with Opicapone: From randomized trials to Phase IV studies in fluctuating Parkinson’s Disease (MDS Congress 2026) - No abstract available

Clinical • P4 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Long-term Safety of Opicapone in Parkinson’s Disease Patients with First Signs of Wearing-off (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy of Opicapone in Early Motor Fluctuations in Parkinson’s Disease: A Comparison of Early versus Later Initiation (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Comparative efficacy and safety of Safinamide versus Opicapone in Japanese patients with Parkinson’s Disease and wearing-off: A matching-adjusted indirect comparison (MDS Congress 2026) - No abstract available

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety of Opicapone After 10 Years of Post-Marketing experience Worldwide (MDS Congress 2026) - No abstract available

Clinical • P4 data • CNS Disorders

Opicapone Co-administration Allows Significant Flow Reduction in Continuous Subcutaneous Foslevodopa/Foscarbidopa Infusion: A Real-World Case Series (MDS Congress 2026) - No abstract available

Clinical • Real-world • Real-world evidence • CNS Disorders

Opicapone for Management of Sleep Disturbances in Parkinson’s Disease: Post-hoc Analysis of the OASIS trial in Patients With and Without Probable RBD (MDS Congress 2026) - No abstract available

Clinical • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Opicapone Shows No Superiority Over Placebo for Fluctuation-Related Pain in Phase 4 Parkinson Trial (NeurologyLive) - "Both arms improved substantially. KPPS domain 3 scores fell 8.8 points (SD, 6.9) with opicapone versus 9.3 points (SD, 6.2) with placebo, a nonsignificant difference of 0.30 point (95% CI, −1.96 to 2.55; P = .7940). KPPS total score fell 18.1 points versus 16.1 points (P = .7538), and MDS-NMS total score fell 28.4 versus 27.1 points (P = .9391), both favoring opicapone numerically but not statistically. Notably, opicapone's KPPS total score improvement exceeded the established 3-point minimum clinically important difference, even without between-group significance."

P4 data • Parkinson's Disease

German Delphi consensus: COMT inhibitors in the management of wearing-off fluctuations in Parkinson's disease. (PubMed, J Neural Transm (Vienna)) - "In summary, the survey provides significant insights into fluctuations diagnosis and the current role of COMT-I in the treatment of PD. The efficacy and tolerability/safety of opicapone observed in clinical trials for the treatment of Parkinson's patients with motor fluctuations are also confirmed in this survey in clinical practice."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Environmentally relevant concentrations of DCOIT impaired lifespan and healthspan in Caenorhabditis elegans. (PubMed, J Environ Sci (China)) - "Importantly, both genetic (comt-4 RNAi) and pharmacological (opicapone) interventions restored dopamine levels, alleviated oxidative stress, and reversed DCOIT-induced aging deficits. Our study established the comt-4/dopamine/oxidative stress axis as a central mechanism in DCOIT toxicity, suggesting dopamine modulation as a potential countermeasure against environmental toxicant-induced aging."

Journal • Metabolic Disorders • COMT

Effect of COMT and UGT1A Variants on Clinical Response to Opicapone in Parkinson's Disease. (PubMed, Mov Disord Clin Pract) - "These results suggest that COMT and UGT1A genotyping may contribute to personalized therapy in PD, although prospective validation is needed."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

REal-life ON PARKinson's - ITaly (REONPARK-IT) (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: Bial - Portela C S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and Safety of Opicapone in Early Parkinson’s Disease: A Prospective Observational Study (EAN 2026) - No abstract available

Clinical • Observational data • CNS Disorders • Movement Disorders • Parkinson's Disease

Opicapone Therapy During Continuous Foslevodopa/Foscarbidopa Infusion: A Good Choice? (EAN 2026) - "OPC appears to be a feasible adjunct during CSFI, supporting higher dopaminergic requirements without increasing infusion flow rates. While generally well tolerated, careful monitoring for neuropsychiatric adverse events is recommended."

Movement Disorders • Parkinson's Disease

Long-term Safety of Opicapone in Parkinson’s Disease Patients with First Signs of Wearing-off (EAN 2026) - "Long-term opicapone exposure was generally safe and well-tolerated in patients with recent-onset fluctuations. Most TEAEs were mild/moderate and consistent with dopaminergic therapy. Dyskinesia occurred less frequently in early versus later starters during the open-label phase, supporting opicapone’ s favorable safety profile when initiated at wearing-off onset."

Clinical • CNS Disorders • Insomnia • Movement Disorders • Parkinson's Disease • Sleep Disorder

Efficacy of Opicapone in Early Motor Fluctuations in Parkinson’s Disease: A Comparison of Early versus Later Initiation (EAN 2026) - "Early opicapone in PD patients with recent-onset wearing-off provided sustained improvements of ~2.5 hours in OFF-time and Good-ON-time, without increasing dyskinesia or levodopa doses. These results support opicapone use in early wearing-off without aggravating the risk of dyskinesia."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Early COMT Inhibition Improves Motor Stability and Real-World Mobility in Parkinson’s Disease: A Randomized Single-Blind Study with Digital Biomarkers (EAN 2026) - " Forty-six PD patients were randomized into two clinically-matched groups ( n = 23 each) receiving either add-on Opicapone 50 mg or an additional levodopa/carbidopa dose (100/25 mg). Early add-on therapy with Opicapone appears more effective than an additional levodopa dose in improving motor stability and patient-perceived well-being in PD patients with emerging motor fluctuations. While CROs may fail to capture changes in long-term motor phenomena, digital biomarkers provide an ecologically valid assessment of real-world motor behaviours."

Biomarker • Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

OPAL-PD: A Longitudinal Observational Study Assessing Health-Related Quality of Life After Opicapone Initiation in Parkinson’s Disease (EAN 2026) - No abstract available

Clinical • HEOR • Observational data • CNS Disorders • Movement Disorders • Parkinson's Disease

Challenges of Pain in Parkinson's Disease: Results from the OCEAN Study. (PubMed, Mov Disord) - "Opicapone did not reach statistical superiority over placebo, highlighting the complexities of studying pain in PD."

Journal • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease

Levodopa Dose-Related Risk of Motor Complications in Early Parkinson’s Disease Patients Treated with Opicapone: Findings from EPSILON Study (EAN 2026) - "Most patients remained free of MCs with OPC; however, a trend toward higher MC risk was observed in patients on higher levodopa doses who initiated OPC later. Early OPC introduction may support motor stability, even at higher levodopa doses."

Clinical • CNS Disorders • Dystonia • Movement Disorders • Parkinson's Disease

FLOW REDUCTION AND LOCAL TOLERABILITY AFTER OPICAPONE USE WITH CONTINUOUS FOSLEVODOPA/FOSCARBIDOPA INFUSION (EAN 2026) - No abstract available

Safety and tolerability of Opicapone in elderly Parkinson’s disease patients: a single-center, real-life retrospective study (EAN 2026) - "These preliminary findings suggest that safety and tolerability were higher in patients with less advanced age and disease severity, with possible gender-related differences. Larger, multicenter prospective studies are warranted."

Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Opicapone for Management of Sleep Disturbances in Parkinson’s Disease: Post-hoc Analysis of the OASIS trial in Patients With and Without Probable RBD (EAN 2026) - "Adding opicapone to levodopa in patients with PD, wearing-off and sleep disturbances improved sleep complaints similarly in patients with and without probable RBD, although the analysis is limited by the small sample size."

Clinical • Retrospective data • CNS Disorders • Dystonia • Mental Retardation • Movement Disorders • Parkinson's Disease • REM Sleep Behavior Disorder • Sleep Disorder

Effect of Opicapone on non-motor burden in fluctuating PD patients: a NoMoFA prospective study (EAN 2026) - "Adjunctive OPC therapy was associated with a significant reduction in fluctuating NMS, particularly during OFF periods, in PD patients with motor fluctuations. These real-world findings support the hypothesis that improved dopaminergic stability may benefit the non-motor domain, reducing the burden of non-motor symptom fluctuations"

Clinical • Movement Disorders • Parkinson's Disease • COMT