Drug · Small Molecule

Crenolanib

CI-DRUG-00000164Explore in graph →NCIt C64639 CHEMBL2105728 CIViC Phase 3

Regulatory

Approvals (0)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Phase 3	Trials	Jurisdictions	First approval	First trial
All cancers	Phase3	Phase 3	4	17	—	—	2005-12
Leukemia	Phase3	Phase 3	1	6	—	—	2012-07
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	0	2	—	—	2011-07

Computedclinicaltrials

Curated evidence

Clinical evidence (22)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–22 of 22 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FLT3 D593del1
Crenolanib +

Clinical trials

Trials with this intervention (18)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–18 of 18 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03250338	Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML	completed	Phase 3	106	Arog Pharmaceuticals, Inc.INDUSTRY	6	Apr 9, 2026	clinicaltrials
NCT03258931	Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML	completed

Molecule

Record

Kind: Small Molecule
Mechanism: Platelet-derived growth factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor
Targets: 3 genes
Aliases: [1-[2-[5-(3-Methyloxetan-3-ylmethoxy)benzimidazol-1-yl]quinolin-8-yl]piperidin-4-yl]amine, 4-Piperidinamine, 1-[2-[5-[(3-methyl-3-oxetanyl)methoxy]-1Hbenzimidazol-1-yl]-8-quinolinyl]-, ARO 002, CP 868 596, CP 868596, CP-868,596, CP-868596, CP868596, Crenolanib, PDGFR Inhibitor CP-868596

Data updated 23 hours agoSource updated unknown

Identifiers

Codes (0)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

FLT3 D835Y1
Crenolanib + FLT3 Tyrosine Kinase Inhibitor TTT-3002 + Lestaurtinib + MidostaurinSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID11085 A panel of 13 FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3 D835Y using MTT growth/survival assay, and results were compared to Ba/F3 cells transfected with FLT3… (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic

FLT3 D835Y1

Crenolanib + FLT3 Tyrosine Kinase Inhibitor TTT-3002 + Lestaurtinib + MidostaurinSubstitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11085

A panel of 13 FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3 D835Y using MTT growth/survival assay, and results were compared to Ba/F3 cells transfected with FLT3… (full text at CIViC)

PMID 28077790 · Nguyen et al., 2017 · Open in CIViC

FLT3 Y572C2
Crenolanib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID12794 Ba/F3 cell lines engineered to express Y572C showed reduced cell viability when exposed to different concentrations of crenolanib [IC50 (nm) 0.89] (no Figure available, data presented in supplemental … (full text at CIViC) PMID 39806020 · Anabtawi et al., 2025 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	submitted	EID12796 Ba/F3 cell lines engineered to express Y572C showed reduced cell viability when exposed to different concentrations of crenolanib [IC50 (nm) not supplied in text] (Figure 1c and 1e). The FLT3 D835Y po… (full text at CIViC) PMID 30651561 · Zhang et al., 2019 · Open in CIViC	civic

FLT3 Y572del2
Crenolanib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID12863 Ba/F3 cell lines expressing the variant FLT3 Y572del showed sensitivity to crenolanib comparable to the FLT3-ITD construct (Figure 4). PMID 33914060 · Young et al., 2021 · Open in CIViC	civic
Crenolanib + Lestaurtinib + Midostaurin + Ponatinib + Quizartinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	submitted	EID9306 The construct supported IL-3 independent growth of Ba/F3 cells. It showed FLT-3 autophosphorylation and downstream signaling via STAT5, AKT, and ERK1/2 pathways. With IL-3 deprivation, the cells showe… (full text at CIViC) PMID 33914060 · Young et al., 2021 · Open in CIViC	civic