Nourianz

(Istradefylline)

ApprovedSmall molecule

Istradefylline is used to help reduce the symptoms of Parkinson's disease, particularly to help improve movement and reduce stiffness in patients who are also taking levodopa.[2] Nourianz is currently approved and in use across 6 indications[4].[1]

Nourianz is one of 175 small molecule programs targeting Amyotrophic Lateral Sclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

174

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Amyotrophic Lateral SclerosisApproved

Liver DiseaseApproved

ApathyActive, not recruiting

Parkinson DiseaseActive, not recruiting

AdultsNot yet recruiting

Spinal Cord InjuryNot yet recruiting

Amyotrophic Lateral SclerosisApproved

Approved

Liver DiseaseApproved

Approved

ApathyPreclinical

Active, not recruiting

Parkinson DiseaseApproved

Active, not recruiting

AdultsPreclinical

Not yet recruiting

Spinal Cord InjuryPhase 2

Not yet recruiting

Competition

Competitive Landscape

100 competitors in Liver Disease

#DrugCompanyPhaseTrials

Nourianz

Kyowa Kirin Co., Ltd.

Approved

22 2

Erleada

Myrbetriq

Nexavar

Dayvigo

Cibinqo

Balversa

Piqray

Kalydeco

Vertex Pharmaceuticals

Sovaldi

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 1/2Not yet recruiting

Spinal Cord Injury

NCT05217498

Q4 2031

PreclinicalNot yet recruiting

Adults

NCT07704385

Clinical

Trials by Indication[1]

Parkinson's Disease12 trials

Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT00957203·308 enrolled

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT00455507·363 enrolled

12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa

Completed·KKyowa Kirin, Inc.·Phase 2·NCT00456794·325 enrolled

Show 9 more trials

An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

Terminated·KKyowa Kirin, Inc.·Phase 3·NCT00199381·504 enrolled

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT00250393·64 enrolled

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT00199355·75 enrolled

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT00199394·405 enrolled

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

Completed·KKyowa Kirin, Inc.·Phase 3·NCT00199420·580 enrolled

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT01968031·613 enrolled

An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018

Completed·KKyowa Kirin, Inc.·Phase 3·NCT00199368·1,100 enrolled

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Completed·KKyowa Kirin, Inc.·Phase 3·NCT00199407·230 enrolled

Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT00955526·373 enrolled

Complication2 trials

Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa

Completed·UUniversity of Chicago·Phase 3·NCT00203957·10 enrolled

A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy

Completed·KKyowa Kirin, Inc.·Phase 2/3·NCT00955045

Metabolism1 trial

The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT02174250·20 enrolled

Abuse Potential1 trial

A Study to Evaluate Abuse Potential of Istradefylline

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT02609477·42 enrolled

Restless Legs Syndrome1 trial

Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome

Completed·KKyowa Kirin, Inc.·Phase 2·NCT00199446·160 enrolled

5 more indications

Hepatic Impairment1 trial

Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT02256033·20 enrolled

Parkinson's Disease (PD)1 trial

A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

Completed·KKyowa Kirin, Inc.·Phase 2·NCT00199433·160 enrolled

Apathy1 trial

Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.

Terminated·MMedical University of South Carolina··NCT05182151·8 enrolled

Spinal Cord Injury1 trial

Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury

Not yet recruiting·—·Phase 1/2·NCT05217498·40 enrolled

Adults1 trial

Enhancing Rehabilitation in Aging Study (ERAS)

Not yet recruiting·UUniversity of Florida·Preclinical·NCT07704385·38 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 27, 2019

NOURIANZ

NDA NDA022075

Aug 27, 2019

NOURIANZ

NDA NDA022075

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Istradefylline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nourianz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Istradefylline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Istradefylline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022075). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nourianz. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Kyowa Kirin Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adenosine A2A Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Kyowa Kirin Co., Ltd.

Patent Landscape[6]

Patent Cliff

Sep 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8318201Sep 5, 2027

7727993Jan 28, 2028

Nourianz

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q4 2031

Trials by Indication[1]

Parkinson's Disease12 trials

Complication2 trials

Metabolism1 trial

Abuse Potential1 trial

Restless Legs Syndrome1 trial

Hepatic Impairment1 trial

Parkinson's Disease (PD)1 trial

Apathy1 trial

Spinal Cord Injury1 trial

Adults1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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