Drug · Small Molecule

Gilteritinib

CI-DRUG-00000273Explore in graph →NCIt C116722 CHEMBL3301622 CIViC Approved

Regulatory

Approvals (4)

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

health-canada-dpdRegulatory4 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as XOSPATA (DIN 02495058) under ATC L01EX13 GILTERITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 3, 2020	health-canada-dpd
EU EMA	Acute Myeloid Leukemia	Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.	approved	Oct 24, 2019	ema
US FDA	—	Efficacy supplement 2019-05-29 (see label)	approved	May 29, 2019	openfda
US FDA	Acute Myeloid Leukemia	XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 days agoSource updated unknown

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	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	32	25	10	53	4	CA, EU, US	Nov 28, 2018	Oct 9, 2013
Leukemia	Approved	Phase 3	28	22	10	47	2	EU, US	Nov 28, 2018	Oct 9, 2013
Malignant Lung Neoplasm	Phase2	Phase 2	2	2	0	3	0	—	—	Sep 8, 2015
Multiple Myeloma	Phase2	Phase 2	1	1	0	1	0	—

Curated evidence

Clinical evidence (21)

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

civicCuratedShowing 1–21 of 21 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 D8351
Gilteritinib	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (58)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 58 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
NCT05564390	MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)	recruiting	Phase 2	2,000	National Cancer Institute (NCI)NIH	3	Sep 25, 2026	clinicaltrials
NCT07140016	A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase receptor FLT3 inhibitor; Tyrosine-protein kinase receptor UFO inhibitor
Targets: 2 genes
UNII: 5RZZ0Z1GJT
Aliases: 6-Ethyl-3-((3-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)amino)-5-((tetrahydro-2H-pyran-4-yl)amino)pyrazine-2-carboxamide, ASP 2215, ASP-2215, ASP2215, Gilteritinib, Gilteritinib Fumarate, Xospata, XOSPATA

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (4)

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

System	Code	Label
ATC (WHO)	L01EX13	GILTERITINIB
DIN (Health Canada)	02495058	XOSPATA

FLT3 D835H1
Gilteritinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID8517 Ba/F3 cells were transfected to express FLT3-ITD or FLT3 tyrosine kinase domain mutations. Immunoblots revealed gilteritinib IC50s of 2nM, 1.6nM, and 5nM for D835H, FLT3-ITD, and wildtype (cell line: … (full text at CIViC) PMID 27908881 · Lee et al., 2017 · Open in CIViC	civic

FLT3 D835H1

Gilteritinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8517

Ba/F3 cells were transfected to express FLT3-ITD or FLT3 tyrosine kinase domain mutations. Immunoblots revealed gilteritinib IC50s of 2nM, 1.6nM, and 5nM for D835H, FLT3-ITD, and wildtype (cell line: … (full text at CIViC)

PMID 27908881 · Lee et al., 2017 · Open in CIViC

FLT3 D835Y3
Gilteritinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	submitted	EID12620 A 60 year old female relapsed or refractory AML patient, white, and 55.2 kg, with favorable cytogenetic risk status Inv(16), and blast percentage of 95, had D835Y at time of bone marrow screening. Var… (full text at CIViC) PMID 32040554 · Tarver et al., 2020 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID8108 A 35 year-old male patient (AML4) presented with a FLT3-ITD mutation at diagnosis and was refractory to induction and salvage chemotherapy. He then received quizartinib and underwent allogenic transpl… (full text at CIViC) PMID 27908881 · Lee et al., 2017 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID8106 Gilteritinib inhibited the cell growth of Ba/F3 cells expressing D835Y (IC50 1.6 nM; 95% CI: 1.1–2.4 nM) compared to controls (IC50 420nM; 95% CI: 350–500 nM). Additionally, immunoblots showed gliteri… (full text at CIViC) PMID 28516360 · Mori et al., 2017 · Open in CIViC	civic