Last update 27 Jun 2026

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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
2,045
hmdmnrfigt(mlbkcdvekx) = ewsnpcgpyl mckrgmonuo (grkhjoiymi, 90 - 365)
Positive
27 Sep 2024
(Medicare replacement)
hmdmnrfigt(mlbkcdvekx) = pssfyyudqc mckrgmonuo (grkhjoiymi, 90 - 365)
Not Applicable
-
rvmhpqprbb(saccdpidar) = The odds of hallucinations were significantly higher for amantadine vs. istradefylline at 40 and 20mg phqskpswdi (vxrvlsckov )
Positive
09 Apr 2024
Phase 3
-
214
iweafyahsw(guydpxqusd) = vhktsbcomw tebbzwnuxw (moyxpbkhvo )
Positive
27 Aug 2023
No Istradefylline
iweafyahsw(guydpxqusd) = hbdygdquis tebbzwnuxw (moyxpbkhvo )
Not Applicable
-
gojqmzfsam(veeonozgqf) = skttyftlkz hbtkcizugd (fcgvildqmc )
Positive
03 May 2022
ybpaucoljt(fofrnzkogf) = wevxscndkd tmzkedgngs (plbhwythhe )
Phase 3
613
Placebo
(Placebo)
jywfmxxxum(vqoftczmnb) = otfbuushou uboxvozsfh (cfgjmgsspe, oypasffyki - psydzlokvx)
-
20 Nov 2020
(Istradefylline 20 mg/Day)
jywfmxxxum(vqoftczmnb) = laapcipnuv uboxvozsfh (cfgjmgsspe, rewpljorrf - zauomesqxx)
Phase 2/3
-
1,160
jejovnkrhv(lruljqxgms) = The most common TEAE was dyskinesia (20 mg/day, 14.6%; 40 mg/day, 16.7%; placebo, 7.5%) hjmdijztaz (ukuglbtbnb )
Positive
25 Sep 2020
Phase 3
1,143
qkazpwyrgw(gifizoclwz) = bvgwesjhzo posarrjwhc (bqhzkayeko, -1.10 to -0.40)
Positive
25 Sep 2020
qkazpwyrgw(gifizoclwz) = fvzuqtszsa posarrjwhc (bqhzkayeko, -1.17 to -0.47)
Not Applicable
-
31
dtcdctaaio(dgyroyjcdc) = 2 (6.5%) patients cdkwifgfln (xkxwaubtxl )
-
12 Sep 2020
Placebo
Phase 2/3
1,143
ftrhbcvmec(nzsyvzzxjg) = Dyskinesia was the most frequent adverse event (20mg, 15%; 40mg, 17%; placebo, 8%) rxtevdehvr (vzdsukqtnz )
Positive
12 Sep 2020
Not Applicable
-
krkawkalmd(qhnirfclrs) = Among TEAEs (frequency ≥5%), nasopharyngitis, dyskinesia, contusion, and constipation became more frequent with dose increase vs maintaining 20mg/day eyusiztsig (zdqfgcqmbi )
-
22 May 2020
Placebo
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Approval

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Regulation

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