Product Description
Oral opicapone (Ongentys®), a potent third-generation, peripheral catechol-O-methyltransferase (COMT) inhibitor, is approved as adjunctive therapy to preparations of levodopa/dopa-decarboxylase inhibitor (L-dopa/DDCI) in adults with Parkinson's disease (PD) and end-of dose (EoD) motor fluctuations. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33428178/)
Mechanisms of Action: COMT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States
Approved Indications: Parkinson Disease
Known Adverse Events: Hypotension | Syncope | Constipation
Company: Bial
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, China
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Parkinson's Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| EPSILON | P3 |
Active, not recruiting |
Parkinson's Disease |
2024-01-01 |
34% |
| EPSILON | P3 |
Active, not recruiting |
Parkinson's Disease |
2023-01-12 |
|
| CTR20230270 | P3 |
Recruiting |
Parkinson's Disease |
None |