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Molecule

Istradefylline

Available on requestNeurology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Istradefylline is a prescription medicine indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. It is available as tablets for oral use. MedsAcross supplies Istradefylline 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

Key facts

ATC classification
N04 Parkinson's disease medicines
US FDA first approval
27 August 2019
EU status
Refused
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 2GZ0LIK7T4CAS 155270-99-8DrugBank DB11757Q905783

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. NOURIANZ is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes.

Source: US FDA prescribing information

How it works

The precise mechanism by which istradefylline exerts its therapeutic effect in Parkinson’s disease is unknown. In in vitro studies and in in vivo animal studies, istradefylline was demonstrated to be an adenosine A 2A receptor antagonist.

Source: US FDA prescribing information

Dosing overview

The recommended dosage is 20 mg orally once daily. The dosage may be increased to a maximum of 40 mg once daily. May be taken with or without food. Patients with hepatic impairment: Maximum recommended dosage with moderate hepatic impairment is 20 mg once daily, use of NOURIANZ in patients with severe hepatic impairment should be avoided. Patients who smoke 20 or more cigarettes per day (or the equivalent of another tobacco product): Recommended dosage is 40 mg once daily.

Source: US FDA prescribing information

Warnings and precautions

Dyskinesia: Monitor patients for dyskinesia or exacerbation of existing dyskinesia. Hallucinations / Psychotic Behavior: Consider dosage reduction or stopping NOURIANZ if occurs. Impulse Control / Compulsive Behaviors: Consider dosage reduction or stopping NOURIANZ if occurs.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Dyskinesia Hallucinations / Psychotic Behavior Impulse Control / Compulsive Behaviors The most common adverse reactions (at least 5% and more frequent than placebo) were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.

Source: US FDA prescribing information

Interactions

Strong CYP3A4 inhibitors: Recommended maximum dosage with concomitant use is 20 mg once daily. Strong CYP3A4 inducers: Avoid use.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Istradefylline, sorted by availability.

MedicineManufacturerRegisterAvailability
Nourianz 20 mg tabletOralKyowa KirinUS FDAAvailable on request
Nourianz 40 mg tabletOralKyowa KirinUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 August 2019Drugs@FDA
EU (EMA)RefusedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Istradefylline in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Istradefylline available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Istradefylline and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Istradefylline have?

The catalogue lists 1 brand names for Istradefylline, including Nourianz.

Is Istradefylline approved by the US FDA?

Yes. The US FDA first approved Istradefylline on 27 August 2019, according to Drugs@FDA.

Does Istradefylline need cold chain shipping?

No listed presentation of Istradefylline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Istradefylline in?

Istradefylline is classified under ATC code N04 (Parkinson's disease medicines).

References

  1. NOURIANZ prescribing information (Kyowa Kirin). U.S. National Library of Medicine, DailyMed. Retrieved 20 May 2025

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