Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Opicapone · 1 trial · 1 indication
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose
Maximum plasma concentration
Time to maximum plasma concentration
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| Opicapone once daily with Carbidopa/Levodopa | EXPERIMENTAL | Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 \& 15 |
| Name | Type | Description |
|---|---|---|
| Opicapone | DRUG | catechol-O-methyltransferase (COMT) inhibitor |
| Carbidopa Levodopa | DRUG | Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor |
Inclusion Criteria: 1. Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment 2. Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD 3. Subjects of childbearing potential who do not pr...
Opicapone is an investigational small molecule being studied for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in clinical trials.
Opicapone is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NBIX. The company is conducting clinical research to evaluate the drug's potential in treating Parkinson's Disease.
Opicapone is currently in Phase 1 clinical development. It is an investigational drug, not yet approved for commercial use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for Parkinson's Disease.
Opicapone has one completed Phase 1 clinical trial, registered as NCT03496870. This study evaluated the pharmacokinetics, pharmacodynamics, and safety of Opicapone in subjects with Parkinson's Disease taking levodopa. The trial enrolled 16 participants in the United States.
Opicapone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Parkinson's Disease. The drug has completed an early-stage clinical trial, but it has not yet received regulatory approval and remains under clinical investigation.