Opicapone is a catechol-O-methyltransferase inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. It is available as capsules for oral use. MedsAcross supplies Opicapone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Opicapone is a 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 a 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).
Source: US FDA prescribing information
The recommended dosage is 50 mg administered orally once daily at bedtime. Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS. The recommended dosage in patients with moderate hepatic impairment is 25 mg orally once daily at bedtime, avoid use in patients with severe hepatic impairment.
Source: US FDA prescribing information
ONGENTYS is contraindicated in patients with: Concomitant use of non-selective monoamine oxidase (MAO) inhibitors. Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. Concomitant use of non-selective monoamine oxidase (MAO) inhibitors. History of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Source: US FDA prescribing information
Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT): May cause arrhythmias, increased heart rate, and excessive changes in blood pressure. Monitor patients when treated concomitantly with products metabolized by COMT. Falling Asleep During Activities of Daily Living: Advise patients prior to treatment. Hypotension/Syncope: If occurs, consider discontinuing ONGENTYS or adjusting dosage of other medications that can lower blood pressure. Dyskinesia: May cause or exacerbate dyskinesia, consider levodopa or dopaminergic medication dose reduction. Hallucinations and Psychosis: Consider stopping ONGENTYS if occurs. Impulse Control/Compulsive Disorders: Consider stopping ONGENTYS if occurs.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT) Falling Asleep During Activities of Daily Living and Somnolence Hypotension/Syncope Dyskinesia Hallucinations and Psychosis Impulse Control/Compulsive Disorders Withdrawal-Emergent Hyperpyrexia and Confusion Most common adverse reactions (≥4% and > placebo): dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased.
Source: US FDA prescribing information
Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. Concomitant use may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Concomitant use of ONGENTYS with non-selective MAO inhibitors is contraindicated. Selective MAO-B inhibitors can be used concomitantly with ONGENTYS.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Opicapone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ongentys 25 mg capsuleOral | Amneal Pharmaceuticals | US FDA | Available on request |
| Ongentys 50 mg capsuleOral | Amneal Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Opicapone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Opicapone, including Ongentys.
Yes. The US FDA first approved Opicapone on 24 April 2020, according to Drugs@FDA.
Yes. Opicapone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Opicapone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Opicapone is classified under ATC code N04BX04 (Opicapone).
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