Ongentys (BIA 9-1067)

Neurocrine Biosciences · FDA-approved active Small molecule Quality 59/100

Ongentys (generic name: BIA 9-1067) is a Catechol-O-Methyltransferase Inhibitor [EPC] Small molecule drug developed by Neurocrine Biosciences. It is currently FDA-approved (first approved 2020) for Parkinson's disease. Also known as: Entacapone, OPC, Opicapone, Opicapone, OPC, Ongentys.

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

Frequently asked questions about Ongentys

What is Ongentys?

Ongentys (BIA 9-1067) is a Catechol-O-Methyltransferase Inhibitor [EPC] drug developed by Neurocrine Biosciences, indicated for Parkinson's disease.

How does Ongentys work?

Ongentys works by blocking the enzyme that breaks down dopamine, allowing more dopamine to be available in the brain.

What is Ongentys used for?

Ongentys is indicated for Parkinson's disease.

Who makes Ongentys?

Ongentys is developed and marketed by Neurocrine Biosciences (see full Neurocrine Biosciences pipeline at /company/neurocrine).

What is the generic name of Ongentys?

BIA 9-1067 is the generic (nonproprietary) name of Ongentys.

Is Ongentys also known as anything else?

Ongentys is also known as Entacapone, OPC, Opicapone, Opicapone, OPC, Ongentys, Opicapone.

What drug class is Ongentys in?

Ongentys belongs to the Catechol-O-Methyltransferase Inhibitor [EPC] class. See all Catechol-O-Methyltransferase Inhibitor [EPC] drugs at /class/catechol-o-methyltransferase-inhibitor-epc.

When was Ongentys approved?

Ongentys was first approved on 2020.

What development phase is Ongentys in?

Ongentys is FDA-approved (marketed).

What are the side effects of Ongentys?

Common side effects of Ongentys include Dyskinesia, Constipation, Blood creatine kinase increased, Hypotension/syncope, Weight decreased, Dizziness.

What is Ongentys's annual revenue?

Ongentys generated approximately $0.0B in annual revenue.

What does Ongentys target?

Ongentys targets Catechol O-methyltransferase and is a Catechol-O-Methyltransferase Inhibitor [EPC].

Related

• Drug class: All Catechol-O-Methyltransferase Inhibitor [EPC] drugs
• Target: All drugs targeting Catechol O-methyltransferase
• Manufacturer: Neurocrine Biosciences — full pipeline
• Therapeutic area: All drugs in Metabolic
• Indication: Drugs for Parkinson's disease
• Also known as: Entacapone, OPC, Opicapone, Opicapone, OPC, Ongentys, Opicapone