Last reviewed · How we verify
Ongentys (BIA 9-1067)
Ongentys works by blocking the enzyme that breaks down dopamine, allowing more dopamine to be available in the brain.
Ongentys (BIA 9-1067) is a small molecule catechol-O-methyltransferase inhibitor developed by Neurocrine, targeting the breakdown of dopamine in the brain. It is FDA-approved for the treatment of Parkinson's disease. As a patented medication, Ongentys is not yet available as a generic. Key safety considerations include the potential for increased risk of dyskinesia and impulse control disorders. Ongentys works by inhibiting the enzyme responsible for breaking down dopamine, allowing more dopamine to be available in the brain.
At a glance
| Generic name | BIA 9-1067 |
|---|---|
| Also known as | Entacapone, OPC, Opicapone, Opicapone, OPC, Ongentys, Opicapone |
| Sponsor | Neurocrine Biosciences |
| Drug class | Catechol-O-Methyltransferase Inhibitor [EPC] |
| Target | Catechol O-methyltransferase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 200 |
Mechanism of action
Opicapone is selective and reversible inhibitor of catechol-O-methyltransferase (COMT). COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain catechol structure. Physiological substrates of COMT include DOPA, catecholamines (dopamine, norepinephrine, and epinephrine), and their hydroxylated metabolites. When decarboxylation of levodopa is prevented by carbidopa, COMT becomes the major metabolizing enzyme for levodopa, catalyzing its metabolism to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
Approved indications
- Parkinson's disease
Common side effects
- Dyskinesia
- Constipation
- Blood creatine kinase increased
- Hypotension/syncope
- Weight decreased
- Dizziness
- Hallucination
- Insomnia
- Hypertension
Key clinical trials
- REal-life ON PARKinson's - ITaly (REONPARK-IT)
- Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health
- OpiCapone Effect on Motor Fluctuations and pAiN (PHASE4)
- OpicApone Sleep dISorder (PHASE4)
- Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) (PHASE3)
- eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. (PHASE4)
- Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers (PHASE1)
- Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ongentys CI brief — competitive landscape report
- Ongentys updates RSS · CI watch RSS
- Neurocrine Biosciences portfolio CI