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Label indication ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 ) FDA label
Also known as BIA 9-1067
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
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Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
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| 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...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
Opicapone is a small molecule drug being developed by Neurocrine Biosciences, Inc. (ticker NBIX) for Parkinson disease. It is a COMT inhibitor and is currently in Phase 1 clinical development. The drug has been studied in a completed Phase 1 trial in the United States.
Opicapone is being developed as an adjunct therapy for Parkinson disease. It is intended for use in patients taking levodopa, as studied in a Phase 1 trial. It is not yet approved and remains investigational.
Opicapone targets catechol-O-methyltransferase (COMT). It acts as a COMT inhibitor. By inhibiting this enzyme, it is designed to affect the metabolism of levodopa in patients with Parkinson disease.
Opicapone is being developed by Neurocrine Biosciences, Inc., which trades under the ticker NBIX. The company is responsible for its clinical development in Parkinson disease.
Opicapone is in Phase 1 clinical development. It has not been approved by the FDA and is considered investigational. One Phase 1 trial has been completed.
Opicapone has been studied in a completed Phase 1 trial, NCT03496870, titled 'A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.' The trial enrolled 16 participants in the United States and was uncontrolled.