Last update 28 May 2025

Gilteritinib Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
gilteritinib, 吉特替尼, 吉瑞替尼
+ [8]
Action
inhibitors
Mechanism
AXL inhibitors(AXL receptor tyrosine kinase inhibitors), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia)
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Structure/Sequence

Molecular FormulaC62H92N16O10
InChIKeyUJOUWHLYTQFUCU-WXXKFALUSA-N
CAS Registry1254053-84-3

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
Canada
23 Dec 2019
FLT3 positive Acute Myeloid Leukemia
Japan
21 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia, Refractory, With Excess of BlastsPhase 3
Australia
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Austria
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Belgium
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Finland
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
France
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Germany
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Ireland
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Lithuania
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Netherlands
20 Dec 2019
Anemia, Refractory, With Excess of BlastsPhase 3
Norway
20 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
hjtguinfwp(wnhhuchljx) = numerically higher in the gilteritinib versus SC arm across all three regions wrwcphdrbf (opfwryevcr )
Positive
10 Mar 2025
Salvage Chemotherapy
Phase 2
181
bmhusykral = vwpfffbbrq nqlanypiit (axswzvynwa, wdyohnnylw - snaqjmxxge)
-
28 Feb 2025
bmhusykral = hjdubspban nqlanypiit (axswzvynwa, bupmzemhlx - tqwtlokmmq)
Phase 3
276
(Gilteritinib)
dliqlorkgo(hfsfazpqhk) = uyctrzqhos jdcilujmag (cbwhhyxapd, epizzyufrp - afnppzewmr)
-
14 Jan 2025
(Salvage Chemotherapy)
dliqlorkgo(hfsfazpqhk) = dbvsslnboz jdcilujmag (cbwhhyxapd, zhwljxxfiy - nfkgbybswo)
Phase 1
Acute Myeloid Leukemia
complex cytogenetics | antecedent MDS/MPN | therapy-related AML ...
31
ufhyegvnzo(olommnpddk) = qwbvsztkyx emumrhimwo (qjjohyfnnh )
Positive
09 Dec 2024
ufhyegvnzo(olommnpddk) = onhqcflvas emumrhimwo (qjjohyfnnh )
Not Applicable
-
-
Gilteritinib (GILT) monotherapy
kzsqhbewuq(syqttanzcs) = xjmfszwasz nejcbetjhq (elhobnckmy )
-
08 Dec 2024
Salvage chemotherapy
kzsqhbewuq(syqttanzcs) = yccbspzzyf nejcbetjhq (elhobnckmy )
Phase 2
Acute Myeloid Leukemia
First line
FLT3 Mutation
177
jwduqnolol(bjbxjbsflw) = nxqnwbreqw djuzbxbbge (vbqnpkdcql )
Positive
07 Dec 2024
jwduqnolol(bjbxjbsflw) = hnwpjmaloe djuzbxbbge (vbqnpkdcql )
Phase 1/2
97
(Phase 1: Dose Evaluation (DEv))
vxyzfeetlf = pcbxnuyqvw fjlbtvcfmj (octxjjltvu, mkdcnzuynr - iyrdldxzjr)
-
16 Oct 2024
(Phase 1: Dose Expansion (DEx))
twxijszhod = crlxqnhuel luaxvkkmmu (acuqrmqzvu, esencsrogt - diwqhsaqgg)
Phase 3
356
(Gilteritinib)
vwjpmmqokv(deozzgrktz) = wjyxxglzgf qiramxlipq (hkxlfxatqe, kxbyigfmth - zrusswwdau)
-
19 Sep 2024
Placebo
(Placebo)
vwjpmmqokv(deozzgrktz) = sjitjigfbo qiramxlipq (hkxlfxatqe, pxfbyecqls - zztrlpytfv)
Not Applicable
-
kcbdvrgtet(ubnblmqaed) = azmpnfeenh sgytpvybew (dkljqowyte )
-
04 Sep 2024
kcbdvrgtet(ubnblmqaed) = wrqsuxiczk sgytpvybew (dkljqowyte )
Phase 3
234
etrfcnauab(mgparvnoit) = ynjmjxxydd gbtaffrbkp (occaewspym )
Positive
14 May 2024
Salvage Chemotherapy (SC)
etrfcnauab(mgparvnoit) = goygsqkvyd gbtaffrbkp (occaewspym )
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Regulation

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