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.

emaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.  Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.

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 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 151–200 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 G250E + ABL1 Fusion5
Dasatinib	Chronic Myeloid Leukemia, BCR-ABL1 Positive

Clinical trials

Trials with this intervention (273)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 201–250 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
NCT01395017	Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer(LAPC)	completed	Phase 2	202	Otsuka Pharmaceutical Development & Commercialization, Inc.INDUSTRY	15	Apr 8, 2016	clinicaltrials
NCT00850382	Dasatinib (Sprycel™) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

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 17 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 G398R + ABL1 Fusion1

Dasatinib

Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS

Predictive

Supports Sensitivity Response

accepted

EID4561

In an in vitro study, a Ba/F3 cell line stably expressing the G398R mutation in the ABL1 portion of the BCR-ABL1 fusion protein was associated with sensitivity to dasatinib treatment (IC50: 1.27nM vs… (full text at CIViC)

PMID 19075254 · Redaelli et al., 2009 · Open in CIViC