Drugs / Istradefylline
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Parkinson disease 1 milestone | |||||
| Filed | US (FDA) | — | Parkinson disease | 2019-03-01 | “the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for istradefylline (KW-6002)” kyowakirin.com ↗ “announced it has resubmitted a New Drug Application to the Food and Drug Administration (FDA) for Istradefylline (KW-6002)” kyowakirin.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Refused (EMA) | EU (EMA) | Nouryant | — | 2022-01-06 | europa.eu ↗ |
| Approved | US (FDA) | NOURIANZ | — | 2019-08-27 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02609477 | Jan → Jul 2016 | substance abuse | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02256033 | Aug → Dec 2014 | — | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02174250 | Jun → Aug 2014 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05217498 | Sep → Dec 2027 expected | spinal cord injury | Randy Trumbower, PT, PhD | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07704385 | Oct 2026 → May 2031 expected | — | University of Florida | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05377424 | Jun 2022 → Jan 2026 overdue | amyotrophic lateral sclerosis | University of Florida | Active not recruiting | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT05333549 | Jul 2022 → Jun 2025 | Parkinson disease, cognitive impairment with or without cerebellar ataxia | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT00455507 | Mar 2007 → Aug 2008 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00250393 | Nov 2005 → Oct 2006 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00199446 | Jul 2005 → Aug 2006 | restless legs syndrome, sleep disorder | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00199433 | May 2005 → Jul 2006 | Parkinson disease, movement disorder | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00199355 | Apr 2005 → Mar 2006 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00456586 | Apr 2002 → May 2003 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00456794 | Mar 2002 → Oct 2003 | Parkinson disease | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 2 | NCT00006337 | Oct 2000 → Jan 2002 | Parkinson disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00955045 | Aug 2002 → Oct 2003 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 310 trials · 1 missed | ||||||
| Phase 3 | NCT02610231 | Dec 2015 → Dec 2017 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01968031 | Oct 2013 → Oct 2016 | Parkinson disease | Kyowa Kirin, Inc. | Completed | Missed primary |
| Phase 3 | NCT00957203 | Oct 2009 → Sep 2011 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00955526 | Jul 2009 → Feb 2011 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00199381 | Oct 2005 → Oct 2008 | Parkinson disease | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00203957 | Mar 2005 → Feb 2007 | Parkinson disease | University of Chicago | Completed | No outcome recorded |
| Phase 3 | NCT00199394 | Nov 2004 → Oct 2005 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00199368 | Oct 2004 → Mar 2007 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00199420 | Jul 2004 → Nov 2005 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00199407 | Jun 2004 → Nov 2005 | Parkinson disease | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05885360 | Jan 2023 → Feb 2024 | Parkinson disease, movement disorder | Georgetown University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-01-06 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency kyowakirin.com ↗ |
| 2019-08-28 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S. kyowakirin.com ↗
Tokyo, Japan, August 28th, 2019 – Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for NOURIANZ™ (istradefylline) for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes. |
| 2019-04-04 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US kyowakirin.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for istradefylline (KW-6002) |
| 2019-03-01 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Refiling of Istradefylline (KW-6002)'s New Drug Application in the US kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Kirin") announced it has resubmitted a New Drug Application to the Food and Drug Administration (FDA) for Istradefylline (KW-6002), an investigational selective adenosine A2A receptor antagonist, for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "OFF" episodes. |
| 2016-12-13 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Top-Line Results of Global Phase 3 Trial of KW-6002 (Istradefylline) for Parkinson's Disease kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that top-line results of a global Phase 3 trial of istradefylline (generic name; code name, KW-6002) did not meet its primary endpoint in patients with Parkinson's disease. |
| 2013-03-25 | Kyowa Kirin, Inc. | Regulatory Approval for manufacturing and marketing of NOURIAST® tablets 20 mg, a novel antiparkinsonian agent kyowakirin.com ↗
NOURIAST® tablets 20 mg (nonproprietary name: istradefylline; referred to below as "NOURIAST®"), a novel antiparkinsonian agent, has been approved for manufacturing and marketing in Japan. |
| 2012-04-02 | Kyowa Kirin, Inc. | Regulatory Announcement regarding the Filing in Japan of an Application for Marketing Approval of KW-6002 for Parkinson's Disease Treatment kyowakirin.com ↗ |
| 2011-05-10 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results of Phase lll Clinical Study of KW-6002 (Istradefylline) for Parkinson's Disease in Japan kyowakirin.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | istradefylline | “Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)” NCT00955526 ↗ |
| Known as | Istradefilina | ChEMBL registry synonym — accepted as the source's own label CHEMBL431770 ↗ |
| Known as | KW-6002 | “Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)” NCT00955526 ↗12“Istradefylline (KW-6002) as monotherapy in Parkinson's Disease (PD) Patients” NCT00199433 ↗ “Oral istradefylline (KW-6002) 20 or 40 mg once daily” NCT00957203 ↗ “Istradefylline ( KW-6002)” NCT00199368 ↗ “Istradefylline (KW-6002)” NCT00199355 ↗ “Istradefylline (KW-6002)” NCT00199407 ↗ “Istradefylline (KW-6002)” NCT00199394 ↗ “Istradefylline (KW-6002)” NCT00456794 ↗ “Istradefylline (KW-6002)” NCT00199420 ↗ “Istradefylline (KW-6002)” NCT00250393 ↗ “Istradefylline (KW-6002)” NCT00199446 ↗ |
| Known as | Nourianz | ChEMBL registry synonym — accepted as the source's own label CHEMBL431770 ↗ |
| Known as | Nouriast | ChEMBL registry synonym — accepted as the source's own label CHEMBL431770 ↗ |
| Action | Inhibit | “This drug blocks the action of the neurotransmitter adenosine” NCT00006337 ↗1“Adenosine A2a receptor antagonist” CHEMBL431770 ↗ |
| Modality | Small molecule | — CHEMBL431770 ↗ |
| Route | Oral | “Patients will take tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active ingredient) once a day” NCT00006337 ↗ |
| Target | ADORA2A | “Adenosine A2a receptor antagonist” CHEMBL431770 ↗ |