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

INFLUENCE OF SOCIODEMOGRAPHIC VARIABLES ON PATIENT AND PRACTITIONER KNOWLEDGE OF PHARMACOLOGICAL MANAGEMENT FOR PARKINSON'S DISEASE (ADPD 2025) - "Younger age is significantly related to higher knowledge of several PD management (aOR 0.42 -0.58) including extended - release capsules, Levodopa -Carbidopa -Entacapone tablets, Rasagiline, Safinamide, R opinirole, Pramipexole, Opicapone, Amantadine, and Trihexyphenidyl/Benzhexol. Practitioners have a statistically significant advantage in identifying most pharmacological management for PD compared to patients. Future research should investigate the quality of communication between patients with PD and practitioners to identify what might be causing this knowledge gap."

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

Factors affecting continuation rates of opicapone: A retrospective study at a single center in Japan. (PubMed, Clin Neurol Neurosurg) - No abstract available

Journal • Retrospective data

Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) (clinicaltrials.gov) - P3 | N=410 | Completed | Sponsor: Bial - Portela C S.A. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

OASIS: OpicApone Sleep dISorder (clinicaltrials.gov) - P4 | N=22 | Completed | Sponsor: Bial - Portela C S.A. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

ADOPTION: eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. (clinicaltrials.gov) - P4 | N=106 | Completed | Sponsor: Bial - Portela C S.A. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

Update on Treatments for Parkinson's Disease Motor Fluctuations - An International Parkinson and Movement Disorder Society Evidence-Based Medicine Review. (PubMed, Mov Disord) - "There are several treatment options that can improve motor fluctuations in PD. These recommendations will assist physicians and patients in determining which intervention to use."

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

Long-term Follow-up of Opicapone Use as Add-on to Levodopa in Parkinson's Patients Without Motor Fluctuations: Findings from the EPSILON Study (AAN 2025) - "This data supports persistent beneficial motor effects over 12 months without increasing dyskinesia risk following the addition of opicapone to levodopa in PD subjects without motor fluctuations."

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

Opicapone as First-line Strategy for the Treatment of Wearing-off in Patients with Parkinson's Disease (AAN 2025) - "OPC 50 mg was superior to an increased daily levodopa dose in reducing wearing-off, suggesting that adding OPC may also be considered as first-line therapeutic option in PD patients with early/less severe motor fluctuations."

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

Opicapone Improved Parkinson's Disease-related Sleep Disturbances: Findings from the OASIS Study (AAN 2025) - "Adding OPC 50mg to levodopa therapy improved sleep disturbances and other non-motor symptoms associated with PD."

CNS Disorders • Fatigue • Movement Disorders • Parkinson's Disease • Sleep Disorder • COMT

OPAILEC: Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: University Hospital of Ferrara | Initiation date: Oct 2022 ➔ Jul 2022

Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

Therapeutic Role of Heterocyclic Compounds in Neurodegenerative Diseases: Insights from Alzheimer's and Parkinson's Diseases. (PubMed, Neurol Int) - "Many clinically approved drugs, such as galantamine hydrobromide, donepezil hydrochloride, memantine hydrochloride, and opicapone, feature heterocyclic cores. As these heterocyclic compounds have exceptional therapeutic potential, heterocycles are an intriguing research topic for the development of new effective therapeutic drugs for PD and AD. This review aims to provide current insights into the development and potential use of heterocyclic compounds targeting diverse therapeutic targets to manage and potentially treat patients with AD and PD."

Journal • Review • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Opicapone for Parkinson's disease-related sleep disturbances: The OASIS clinical trial. (PubMed, J Parkinsons Dis) - "Adding opicapone 50 mg to levodopa/DDCI therapy in patients with PD and motor fluctuations and sleep disturbances improved both sleep disturbances and OFF time in these patients."

Journal • CNS Disorders • Fatigue • Movement Disorders • Parkinson's Disease • Sleep Disorder

Opicapone to Treat Early Wearing-off in Parkinson's Disease Patients: The European Experience. (PubMed, Mov Disord Clin Pract) - No abstract available

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

Opicapone as adjunct to levodopa in treated Parkinson's disease without motor complications: A randomized clinical trial. (PubMed, Eur J Neurol) - P3 | "Treatment with once-daily adjunct opicapone was well tolerated, improved motor severity, and did not induce the development of motor complications. These results support the clinical usefulness of opicapone in the management of PD patients without motor complications."

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

OCEAN: OpiCapone Effect on Motor Fluctuations and pAiN (clinicaltrials.gov) - P4 | N=144 | Completed | Sponsor: Bial - Portela C S.A. | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Feb 2024 | Trial primary completion date: Dec 2022 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease

Spike-In Proteome Enhances Data-Independent Acquisition for Thermal Proteome Profiling. (PubMed, Anal Chem) - "The integration of DIA-TPP with the matrix-augmented pooling strategy (MAPS) to increase experiment throughput demonstrates performance comparable to that of existing TMT-TPP-MAPS. With this spike-in proteome strategy, we also successfully identified the thermal stabilization of CA13 by dorzolamide hydrochloride as well as GSTZ1 and tyrosyl-DNA phosphodiesterase 1 of opicapone that eluded detection without spike-in proteome."

Journal • TDP1

Driving Abilities and Wearing-Off in Parkinson's Disease: A Driving Simulation Study. (PubMed, Brain Sci) - "DwP demonstrated impaired driving compared to controls. Wearing-off symptoms can also affect driving ability, but therapies (opicapone more so than MAO inhibitors) may play a role in preserving specific driving skills, possibly through maintaining learning abilities."

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

Clinical pharmacokinetics of levodopa and relevant add-on therapies for Parkinson's disease. (PubMed, Expert Opin Drug Metab Toxicol) - "Opicapone induced higher levodopa plasma levels compared with the ones following application of levodopa/carbidopa alone or combined with entacapone or tolcapone. Co-administration of opicapone with its once daily intake regimen may support the efficacy of subcutaneous and intrajejunal levodopa infusions."

Journal • PK/PD data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Levodopa / opicapone as a complement to STN-DBS in clinical practice. A retrospective single-centre analysis. (PubMed, eNeurologicalSci) - "These results indicate a clinical phenotype characterised by more motor fluctuations requiring a more stable dopamine replacement therapy to address the patients' disease biology. In these cases, levodopa + COMT inhibition by opicapone represents a therapeutic approach but determination of the potential clinical benefit requires further prospective studies."

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

Recent advancements and updates in the management of Parkinson's disease (Neuroscience 2024) - "Dyskinesia was significantly decreased in the studies of immediate-release/extended-release amantadine (OS320) with treatment differences of ≥8. Conclusion Pharmacological therapies such as ND0612, Opicapone, Safinamide, and LCIG have the potential to improve the Quality of Life in PD by decreasing motor symptoms and dyskinesias. STN-DBS can also be a cutting-edge measure in the overall management of patients. Further studies should be directed toward the use of combination therapies and precision-based treatment regimens for refractory cases."

Late-breaking abstract • CNS Disorders • Parkinson's Disease

Comparative analysis of opicapone and entacapone in the management of motor fluctuations in patients with Parkinson’s disease, from clinical trials to healthcare resource usage (MDS Congress 2024) - "Opicapone's sustained COMT inhibition, once-daily dosing convenience, favorable efficacy and safety profiles distinguish it from ENT, potentially offering improved patient outcomes, treatment adherence and reduced healthcare cost."

Clinical • CNS Disorders • Parkinson's Disease • COMT

Opicapone real-world experience in early motor fluctuations: 3-months analysis of the REONPARK study. (MDS Congress 2024) - "Available iCOMT include opicapone, entacapone and tolcapone. Opicapone demonstrated effective control of motor symptoms and good tolerability in PD patients with EMF in routine clinical practice after 3 months."

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

When Off Can Cost Life: Myocardial Infarction Due to Spontaneous Coronary Dissection as a Catastrophic Manifestation in Advanced Parkinson's Disease. (MDS Congress 2024) - "After adding opicapone and rescue subcutaneous apomorphine, a significant control of OFF symptoms was achieved... This exceptional case describes a PD patient without cardiovascular risk factors who suffered severe hearth dysautonomia occurring during an OFF period that put her life at risk. Although dysautonomic signs should be considered as part of PD symptoms it should be noted that they can be a true emergency to provide timely and targeted treatment."

Metastases • CNS Disorders • Dystonia • Pain • Parkinson's Disease • Psychiatry

If Oral Levodopa is not Possible, Keep Calm and Breathe Deeply (MDS Congress 2024) - "Due to severe motor fluctuations and severe dysphagia episodes, it was decided to start levodopa/carbidopa intestinal gel infusion as advanced therapy. His treatment at that time was oral levodopa divided into 6 doses, safinamide, rivastigmine and, for delayed ON in the morning and for unpredictable OFF, inhaled levodopa had been prescribed. He had presented intolerance to opicapone, rasagiline and dopamine agonists, the latter with impulse control disorder and hallucinations at low doses... – Inhaled levodopa could be of choice in patients without tolerance to oral/enteral or transdermal treatments. – Future studies should provide more real-life data on this utility beyond the objective of clinical trials."

CNS Disorders • Pain • Parkinson's Disease

Opicapone Reduces Homocysteine Levels in Patients with Parkinson's Disease Treated with Levodopa Gel Infusion (MDS Congress 2024) - "We have previously proved that add-on treatment with COMT inhibitor tolcapone reduced LCIG/CLES daily dose and decreased HCY levels [1]. Opicapone might have the potential to reduce HCY plasmatic levels in patients with advanced PD treated by LCIG/CLES, probably by decreased peripheral conversion of levodopa to 3-O-methyldopa and, thus, also possibility to reduce the daily dose of LCIG/CLES. The change in homocysteine levels (in μmol/l)"

Clinical • CNS Disorders • Parkinson's Disease • COMT