Friday, July 10, 2026

Drug profile · INN

opicapone

opicapone (ONGENTYS) is a catechol o-methyltransferase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Nervous system (N04) N04
US status approved
Patents linked 7
Pipeline programs 1
News articles 0
Drug details — opicapone
US status
approved
Class
Nervous system (N04)
Route
ORAL
Patents
7
Programs
1
Data quality
0.89

Quick answer

opicapone (ONGENTYS) is a catechol o-methyltransferase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN opicapone
Brand ONGENTYS
Mechanism Catechol O-methyltransferase inhibitor
Target Catechol O-methyltransferase
Therapeutic class Nervous system (N04)
Route ORAL
Formulation CAPSULE
ATC code N04

Mechanism of action

Catechol O-methyltransferase inhibitor

Primary target: Catechol O-methyltransferase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. Opicapone Phase 1 · NEUROCRINE BIOSCIENCES · Parkinson Disease

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. AU 2023244944

    PRODRUGS OF OPICAPONE

    Expires Wed Sep 28 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2022158991

    TRAITEMENT DE LA DOULEUR ASSOCIÉE À LA MALADIE DE PARKINSON AVEC DE L'OPICAPONE EN COMBINAISON AVEC LA LÉVODOPA

    Expires Wed Jul 23 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2022081033

    OPICAPONE ET LÉVODOPA POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON

    Expires Wed Apr 16 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. WO 2022025781

    DISPERSION SOLIDE D'OPICAPONE

    Expires Wed Jan 29 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. CA 3183290

    COMPRIME COMPRENANT DE L'OPICAPONE

    Expires Wed Nov 27 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. WO 2021182981

    OPICAPONE MICRONISÉE

    Expires Wed Sep 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. CA 3174918

    OPICAPONE MICRONISEE

    Expires Wed Sep 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is opicapone?

opicapone (ONGENTYS) is a catechol o-methyltransferase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for opicapone?

ONGENTYS is a marketed brand name for opicapone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of opicapone?

opicapone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.