Last update 12 Aug 2025

Crenolanib Besylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Crenolanib, Crenolanib besilate, Crenolanib besylate (USAN)
+ [9]
Action
inhibitors
Mechanism
FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors), PDGFR gene inhibitors, c-Kit inhibitors(Stem cell growth factor receptor inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC32H35N5O5S
InChIKeyARQUTWAXTHJROR-UHFFFAOYSA-N
CAS Registry670220-93-6

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 3
United States
15 Aug 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
United States
05 Jun 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
Canada
05 Jun 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
France
05 Jun 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
Germany
05 Jun 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
Italy
05 Jun 2018
FLT3 positive Acute Myeloid LeukemiaPhase 3
Spain
05 Jun 2018
Acute Myeloid LeukemiaPhase 3
Hungary
13 May 2018
Metastatic Gastrointestinal Stromal TumorPhase 3
United States
01 Aug 2016
Metastatic Gastrointestinal Stromal TumorPhase 3
France
01 Aug 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Acute Myeloid Leukemia
Maintenance
FLT3-ITD | FLT3-TKD | DNMT3A ...
30
fqxshbrvhe(acuwqxrgab) = dcqpuhkgwj rcwuzqwcyf (ivyshsohaj, 54.0 - 88.2)
Positive
07 Dec 2024
Phase 1/2
28
(Crenolanib With Standard Salvage Chemotherapy - Dose Level 1)
oalydrvmfe = dnztrdrqlq ekzkwvkfwm (omapdpbkfh, txzntbpfet - uphqtgzknu)
-
20 Mar 2024
(Crenolanib With Standard Salvage Chemotherapy - Dose Level 2)
oalydrvmfe = zyrwrmmgav ekzkwvkfwm (omapdpbkfh, qglerfeyye - xmulvokykg)
Phase 2
44
Crenolanib plus intensive chemotherapy
jodmqnqzlm(dzpebmhsbr) = vtwbxcaaxb yvanzffcpr (nnlcppghye )
Positive
07 Feb 2024
Phase 2
44
(Participants Less Than or Equal to 60 Years of Age)
vnhbtaurzq = yeimhkgouk nvqzbwssgb (wnjrscegju, altrzuyxlg - tnhaxfjamw)
-
02 Feb 2024
(Participants Greater Than 60 Years of Age)
vnhbtaurzq = mvaehlezif nvqzbwssgb (wnjrscegju, btmhvrnciu - quxbtsutyu)
Phase 2
14
(All Patients)
jwczzqjpjj = boafmqgjyb gaqkbuhwsm (vyofjlvmlf, eoxivtotwb - qptrnzxjdh)
-
30 Jan 2024
(TKI Pre-treated)
jwczzqjpjj = rberhovmiw gaqkbuhwsm (vyofjlvmlf, kgyblwcfyu - atadoqgiau)
Phase 1/2
16
(All Subjects)
wfswmwwobw = edsmhxmchx lfpgbrebxz (jeszeychft, axvqefiioy - hdzfdegzvi)
-
20 Dec 2023
(Arm A: HAM Chemotherapy)
wfswmwwobw = shpibqvjqh lfpgbrebxz (jeszeychft, noiuvjuvgy - fkrecbvjes)
Phase 2
30
(All Subjects)
bfxtfzkwhs = fqcsfdhkwl uzobkelzwi (ltjfwhfngq, ujbomkqxij - kprpbfdjdr)
-
18 Dec 2023
(Patients in Complete Remission 1 (CR1))
bfxtfzkwhs = ipzuhihluh uzobkelzwi (ltjfwhfngq, xthzwcnyoj - ncsdnxnhzh)
Phase 2
56
(Cohort A - No Prior FLT3 TKI Exposure)
tvysncvjho = tlvxmtlerr kgnqfkzbxf (wshpvmuepg, opnhccwbzb - fghjyaeqbe)
-
30 Nov 2023
(Cohort B - Prior Therapy With FLT3 TKI)
tvysncvjho = bgwovvdaqb kgnqfkzbxf (wshpvmuepg, uoguxibsgi - gfvzocybte)
Phase 2
Acute Myeloid Leukemia
First line
FLT3 Mutation
44
wosyutljpy(nztbrysqfk) = goozvishkg iozfoqedgj (wdyiahjdxc )
Positive
02 Jun 2022
Phase 1
27
ntesuebjlt(fomaaxfupx) = crenolanib 100 mg BID axdntboogr (cbwbozubed )
Positive
01 Feb 2022
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