ONGENTYS (opicapone)
ONGENTYS is indicated for the treatment of Parkinson's Disease.
How ONGENTYS Works
Opicapone functions as a selective and reversible inhibitor of catechol-O-methyltransferase (COMT), an enzyme that metabolizes physiological substrates like levodopa and dopamine. When the decarboxylation of levodopa is blocked by carbidopa, COMT becomes the primary enzyme responsible for breaking down levodopa into 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD). By inhibiting COMT, the drug prevents this metabolic process. This mechanism helps maintain levodopa levels when used in combination with levodopa/carbidopa therapy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-04-24
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ONGENTYS Approval History
What ONGENTYS Treats
1 indicationsONGENTYS is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
ONGENTYS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ONGENTYS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04990284 ADOPTION | BIA-91067-403 2020-002754-24 | Ph 4 | completed | eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. |
| NCT04986995 OASIS | BIA-91067-405 2020-001176-15 | Ph 4 | completed | OpicApone Sleep dISorder |
| NCT03820037 | BIA-91067-132 | Ph 1 | completed | Relative Bioavailability and Bioequivalence of Opicapone |
| NCT01851850 | BIA-91067 | Ph 3 | completed | Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial |
| NCT03496870 | NBI-OPC-1706 | Ph 1 | completed | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONGENTYS FDA Label Details
Indications & Usage
FDA Label (PDF)ONGENTYS is indicated for the treatment of Parkinson's Disease.
ONGENTYS Patents & Exclusivity
Patents (9 active)
Pro Intelligence Preview
Deep insights for ONGENTYS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 44 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment