Drug · Small Molecule

Dasatinib

CI-DRUG-00000179Explore in graph →NCIt C38713 CHEMBL5416410 CIViC Approved

Regulatory

Approvals (43)

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-dpdRegulatory43 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 APO-DASATINIB TABLETS (DIN 02562464) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd

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 18 hours 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 4	45	19	19	268	43	CA, EU, US	Jun 28, 2006	Jul 13, 2001
Non-Hodgkin Lymphoma	Phase4	Phase 4	6	4	0	20	0	—	—	Sep 17, 2007
Multiple Myeloma	Phase4	Phase 4	4	2	0	10	0	—	—	2008-02
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	1	1	1	10	0

Curated evidence

Clinical evidence (319)

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

civicCuratedShowing 1–50 of 319 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
ABL1 Fusion2
Dasatinib	Acute Lymphoblastic Leukemia

Clinical trials

Trials with this intervention (273)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 273 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
NCT06124157	A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)	recruiting	Phase 2	222	National Cancer Institute (NCI)NIH	4	Sep 28, 2026	clinicaltrials
NCT02389309	Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Platelet-derived growth factor receptor beta inhibitor; Stem cell growth factor receptor inhibitor; Ephrin type-A receptor 2 inhibitor; SRC inhibitor; Bcr/Abl fusion protein inhibitor
Targets: 15 genes
UNII: RBZ1571X5H
Aliases: 5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)-1-piperazinyl)-2-methyl-4-pyrimidinyl)amino)-, Monohydrate, APO-DASATINIB, BMS 354825, BMS354825, BMS-354825-03, BMS-354825 HYDRATE, Dasatinib, Dasatinib Accord, Dasatinib accord healthcare, Dasatinib Accordpharma, Dasatinib hydrate, Dasatinib Hydrate, Dasatinib Monohydrate, NSC-759877, PHYRAGO, Sprycel, SPRYCEL, TARO-DASATINIB, TEVA-DASATINIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (59)

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

System	Code	Label
ATC (WHO)	L01EA02	DASATINIB
DIN (Health Canada)

ABL1 T315I + ABL1 Fusion6
Dasatinib	Acute Lymphoblastic Leukemia	Predictive	C	Supports Resistance	2	submitted	EID4374 In a retrospective study of 45 imatinib-resistant or -intolerant Philadelphia chromosome BCR-ABL fusion positive (Ph+) chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia (ALL) patients, pati… (full text at CIViC) PMID 17339191 · Soverini et al., 2007 · Open in CIViC	civic
〃	Acute Lymphoblastic Leukemia	Predictive	C	Supports Resistance	2	submitted	EID4375 In a retrospective study of 174 imatinib-resistant or -intolerant Philadelphia chromosome BCR-ABL1 fusion positive accelerated phase chronic myeloid leukemia patients, patients with the T315I mutation… (full text at CIViC) PMID 19487385 · Apperley et al., 2009 · Open in CIViC	civic
〃	Acute Lymphoblastic Leukemia	Predictive	C	Supports Resistance	2	accepted	EID4376 In this phase II multinational study, patients with accelerated phase CML and BCR-ABL fusions were treated with dasatinib monotherapy. Response rate among 60 imatinib-resistant patients with BCR-ABL m… (full text at CIViC) PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic
〃	Acute Lymphoblastic Leukemia	Predictive	D	Supports Resistance	2	submitted	EID4377 In an in vitro study, a Ba/F3 cell line stably expressing the T315I mutation in the ABL1 portion of the BCR-ABL1 fusion protein was associated with reduced sensitivity to dasatinib treatment (IC50: 1… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Acute Lymphoblastic Leukemia	Predictive	D	Supports Resistance	2	submitted	EID4378 In an in vitro study, a Ba/F3 cell line stably expressing the T315I mutation in the ABL1 portion of the BCR-ABL1 fusion protein was found to have reduced sensitivity to dasatinib treatment, comparable… (full text at CIViC) PMID 15256671 · Shah et al., 2004 · Open in CIViC	civic
Dasatinib + Imatinib + NilotinibSubstitutes	Acute Lymphoblastic Leukemia	Predictive	D	Supports Resistance	3	accepted	EID7778 Bone marrow mononuclear cells (BM MNCs) isolated from three acute lymphoblastic leukemia patients with the BCR-ABL1 T315I variant. Patients were pretreated with various chemotherapeutics and dasatinib… (full text at CIViC) PMID 25686603 · Pemovska et al., 2015 · Open in CIViC	civic

ABL1 Fusion7
Dasatinib + ImatinibSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID12385 Functional activity and treatment response were evaluated for several fusions identified in patients with gene expression profiles showing BCR::ABL1-like B-ALL. Phosphoflow on leukemic samples from 2 … (full text at CIViC) PMID 22897847 · Roberts et al., 2012 · Open in CIViC	civic
Dasatinib + Imatinib + Nilotinib + PonatinibSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	2	accepted	EID9150 A 22-year-old male with B-cell acute lymphoblastic leukemia was treated with induction therapy. FISH using a BCR-ABL1 probe demonstrated 50-80 extrachromosomal copies of ABL1; FISH using probes to the… (full text at CIViC) PMID 23175662 · Eyre et al., 2012 · Open in CIViC	civic
Dasatinib	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	B	Supports Sensitivity Response	3	submitted	EID13328 Of 40 patients with BCR::ABL1-like (Ph-like) B-cell acute lymphoblastic leukemia (B-ALL), one 16-year-old male was found to have a NUP214::ABL1 fusion identified by genomic profiling (RT-PCR, next-gen… (full text at CIViC) PMID 25049327 · Roberts et al., 2014 · Open in CIViC	civic
〃	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	C	Supports Sensitivity Response	3	submitted	EID13327 A 26-year-old female with Philadelphia chromosome-like (Ph-like) B-cell acute lymphoblastic leukemia (B-ALL) had a NUP214::ABL1 fusion detected by a next-generation sequencing panel experienced persis… (full text at CIViC) PMID 31014138 · Aldoss et al., 2019 · Open in CIViC	civic
Dasatinib + NilotinibSequential	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	C	Supports Sensitivity Response	3	submitted	EID13329 A 21-year-old patient with refractory B-cell acute lymphoblastic leukemia (B-ALL) had a NUP214::ABL1 fusion identified by clinical next-generation sequencing failed multiple prior treatment regimens, … (full text at CIViC) PMID 37933765 · Shumock et al., 2023 · Open in CIViC	civic
Dasatinib + Dexamethasone + VincristineCombination	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	C	Supports Sensitivity Response	2	accepted	EID7208 A 15-year-old girl with B-cell precursor ALL was placed into the very high risk group after showing corticoid resistance on treatment day 8, and induction failure on day 35 (MRD >0.01). The patient re… (full text at CIViC) PMID 26681761 · Duployez et al., 2016 · Open in CIViC	civic
Dasatinib + ImatinibCombination	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	B	Supports Sensitivity Response	3	submitted	EID13330 In a cohort of six patients with NUP214::ABL1-positive Ph-like B-ALL, detected by multiplex molecular assays for fusion transcript identification, including RNA sequencing, treatment with ABL-directed… (full text at CIViC) PMID 31434701 · Tanasi et al., 2019 · Open in CIViC	civic

ABL1 Fusion5
Dasatinib	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID9164 Authors reported a 40-yr-old male patient with pre-B ALL and t(1;9)(q24;q34) translocation. Two different RCSD1-ABL1 fusion transcripts, presumably resulting from alternative splicing, were identified… (full text at CIViC) PMID 19794096 · Mustjoki et al., 2009 · Open in CIViC	civic
〃	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID9165 Authors reported a 15-year-old female patient with B-ALL diagnosed in June 2014. Conventional cytogenetics and FISH identified t(1;9)(q23;q34) and RCSD1ABL1 fusion. Microarray identified an approximat… (full text at CIViC) PMID 26600955 · Kamran et al., 2015 · Open in CIViC	civic
〃	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	C	Supports Reduced Sensitivity	3	accepted	EID9166 Author reported a 31-year-old male patient diagnosed with B-ALL. RT-PCR and sequence analyses detected transcription of a single RCSD1-ABL1 fusion gene variant, which had breakpoints in exon 3 of RCSD… (full text at CIViC) PMID 21863287 · Inokuchi et al., 2011 · Open in CIViC	civic
〃	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID9168 Authors reported a 61-year old female diagnosed with B-ALL in August 2012. The RCSD1-ABL1 t(1;9)(q22;q34) fusion between exon 3 of RCSD1 and exon 4 of ABL1 was identified by RT-PCR. The patient was en… (full text at CIViC) PMID 28057740 · Frech et al., 2017 · Open in CIViC	civic
〃	B Lymphoblastic Leukemia/Lymphoma, BCR-ABL1-Like	Predictive	D	Supports Sensitivity Response	3	accepted	EID7249 The ABL1-RCSD1 fusion was identified in a 6 yo boy with Ph-like B-ALL and hyperleukocytosis. Following standard induction therapy the patient had an MRD of 16.4% in bone marrow, indicating a poor resp… (full text at CIViC) PMID 25207766 · Roberts et al., 2014 · Open in CIViC	civic

ABL1 Fusion2
Dasatinib	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID7241 A 7-yr-old boy with B-cell precursor acute lymphoblastic leukemia was found to harbor the SNX2-ABL1 fusion gene. Gene expression analysis showed enrichment for BCR-ABL1+ ALL using GSEA. After first re… (full text at CIViC) PMID 24215620 · Masuzawa et al., 2014 · Open in CIViC	civic
Dasatinib + ImatinibSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID7655 SNX2-ABL1 protein (SNX2 exon 3 to ABL1 exon 4) was transfected in murine Ba/F3 cells and proliferation rates in the presence of IL-3, and tyrosine kinase inhibitors, imatinib and dasatinib was compare… (full text at CIViC) PMID 24367893 · Tomita et al., 2014 · Open in CIViC	civic

ABL1 BCR::ABL F317L2
Dasatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	—	rejected	EID4388 In a retrospective study (of phase 3 clinical trial NCT00481247) of 363 Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia patients in chronic phase, a patient with the F317I mutation in … (full text at CIViC) PMID 26118315 · Hughes et al., 2015 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	—	rejected	EID4389 In a study of 51 imatinib-resistant chronic myeloid leukemia patients, patients with the F317L or F317V mutation in the ABL1 portion of the BCR-ABL1 gene fusion (n=10) were associated with acquired re… (full text at CIViC) PMID 27485109 · Soverini et al., 2016 · Open in CIViC	civic