Istradefylline

Overview

Istradefylline, or KW6002, was developed by Kyowa Hakko Kirin in Japan for the treatment of Parkinson's disease as an adjunct to standard therapy. Unlike standard dopaminergic therapies for Parkinson's, Istradefylline targets adenosine A receptors in the basal ganglia. This region of the brain is highly involved in motor control. Istradefylline is indicated as an adjunct treatment to levodopa and carbidopa for Parkinson's disease. This drug was first approved in Japan on 25 March 2013. Istradefylline was granted FDA approval on 27 August 2019.

Indication

Istradefylline is indicated in adjunct to levodopa and carbidopa in the treatment of Parkinson's disease.

Associated Conditions

Parkinson's Disease (PD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Istradefylline Effect Protocol on Parkinson's Disease Tremor	2023/06/01	NCT05885360	Phase 4	Completed	Georgetown University
Adenosine 2A Receptor Antagonism and AIH in ALS	2022/05/17	NCT05377424	Phase 1	Recruiting	University of Florida
Istradefylline for Parkinson Disease With Cognitive Impairment	2022/04/19	NCT05333549	Phase 2	Active, not recruiting	Virginia Commonwealth University
Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury	2022/02/01	NCT05217498	Phase 1	Not yet recruiting	Randy Trumbower, PT, PhD
Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.	2022/01/10	NCT05182151	N/A	Terminated	Medical University of South Carolina
A Study to Evaluate Abuse Potential of Istradefylline	2015/11/20	NCT02609477	Phase 1	Completed	Kyowa Kirin Co., Ltd.
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease	2015/11/20	NCT02610231	Phase 3	Completed	Kyowa Kirin Co., Ltd.
Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline	2014/10/03	NCT02256033	Phase 1	Completed	Kyowa Kirin Co., Ltd.
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.	2014/06/25	NCT02174250	Phase 1	Completed	Kyowa Kirin Co., Ltd.
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease	2013/10/23	NCT01968031	Phase 3	Completed	Kyowa Kirin Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
NOURIANZ	Kyowa Kirin, Inc.	42747-604	ORAL	40 mg in 1 1	3/13/2023
NOURIANZ	Kyowa Kirin, Inc.	42747-602	ORAL	20 mg in 1 1	3/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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