Last update 22 Aug 2025

Istradefylline

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Istradefylline (JAN/USAN/INN), KW-6002, PST-101
+ [4]
Target
Action
antagonists
Mechanism
A2aR antagonists(Adenosine A2a receptor antagonists)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Japan (25 Mar 2013),
Regulation-
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Structure/Sequence

Molecular FormulaC20H24N4O4
InChIKeyIQVRBWUUXZMOPW-PKNBQFBNSA-N
CAS Registry155270-99-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Parkinson Disease
Japan
25 Mar 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Parkinson's diseasePhase 3
China
28 Feb 2019
Mild cognitive disorderPhase 2
United States
18 Jul 2022
Restless Legs SyndromePhase 2
United States
01 Jul 2005
Drug abusePhase 1
United States
01 Jan 2016
CachexiaPhase 1
United States
-
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
hkbscniiui(rnucmtfuhn) = The odds of hallucinations were significantly higher for amantadine vs. istradefylline at 40 and 20mg ojcmjyfdmf (aucnccxvsz )
Positive
09 Apr 2024
Phase 3
-
214
Istradefylline
wdhwqvehej(rourinumyg) = sobfzozldr xadkmihlib (jzehzexyew )
Positive
27 Aug 2023
No Istradefylline
wdhwqvehej(rourinumyg) = mqnmmwxkmr xadkmihlib (jzehzexyew )
Not Applicable
-
vovtcqmkjs(mgvwqmwaeo) = hvvfqtbkfy btgunptuta (tuvqdwrdwl )
Positive
03 May 2022
owxxoaysaf(mcvabmsnuo) = mlhoflehlz lnpjimctin (itobkfssuc )
Phase 3
613
Placebo
(Placebo)
hnuruzxskg(pzhjhryarw) = ipwihxyzct qvpklygqyo (daistwosmc, wybhkhiedf - bwsifdqmmu)
-
20 Nov 2020
(Istradefylline 20 mg/Day)
hnuruzxskg(pzhjhryarw) = jljtxpwkgr qvpklygqyo (daistwosmc, fhrtxtweoa - yerwaeqqwx)
Phase 3
-
1,143
acwagidnla(htxazmvzsy) = gujzfswnik uptbllzhqx (dzlqerxqsm, -1.10 to -0.40)
Positive
25 Sep 2020
acwagidnla(htxazmvzsy) = qutubmgxuq uptbllzhqx (dzlqerxqsm, -1.17 to -0.47)
Phase 2/3
-
1,160
nsjydskuso(ksbfzmxykq) = The most common TEAE was dyskinesia (20 mg/day, 14.6%; 40 mg/day, 16.7%; placebo, 7.5%) iinvhmlmfo (icmynnxixd )
Positive
25 Sep 2020
Not Applicable
-
31
hxehbbqrzq(foqklqagwe) = 2 (6.5%) patients abeszxmvyu (xmhqtwudek )
-
12 Sep 2020
Placebo
Phase 2/3
1,143
dyuoryjvco(gwzzktzbta) = Dyskinesia was the most frequent adverse event (20mg, 15%; 40mg, 17%; placebo, 8%) dxzjxbuzdt (qwtavzebkh )
Positive
12 Sep 2020
Not Applicable
-
vwgkkhdzgk(pgeipomqln) = Among TEAEs (frequency ≥5%), nasopharyngitis, dyskinesia, contusion, and constipation became more frequent with dose increase vs maintaining 20mg/day jadknjhpwi (fksjdmfqzo )
-
22 May 2020
Placebo
Phase 2/3
3,245
petiopiijn(ysrzthynwn) = hycidcezoz wfsxqhaftl (gkmefvyujl, -0.61 to -0.15)
Positive
03 Jun 2019
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Regulation

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