Drug · Small Molecule

Bosutinib

CI-DRUG-00000114Explore in graph →NCIt C60809 CHEMBL288441 CIViC Approved

Regulatory

Approvals (15)

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-dpdRegulatory15 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 REDDY-BOSUTINIB (DIN 02560038) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 8, 2025	health-canada-dpd
CA

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	6	3	5	35	15	CA, EU, US	Sep 4, 2012	2004-10
Leukemia	Approved	Phase 4	4	2	4	24	3	EU, US	Sep 4, 2012	Jan 18, 2006
Multiple Myeloma	Phase2	Phase 2	1	1	0	1	0	—	—	Mar 23, 2018
Non-Hodgkin Lymphoma	Phase2	Phase 2	1	1	0	1	0	—	—

Curated evidence

Clinical evidence (91)

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

civicCuratedShowing 1–50 of 91 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 Non-P-Loop Mutation + ABL1 P-Loop Mutation + ABL1 TKD Mutation1
Bosutinib

Clinical trials

Trials with this intervention (41)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–41 of 41 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
NCT06423911	Study of Olverembatinib (HQP1351) in Patients With CML-CP(POLARIS-2)	recruiting	Phase 3	333	Ascentage Pharma Group Inc.INDUSTRY	16	Sep 15, 2026	clinicaltrials
NCT04971226	A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP	active not recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Tyrosine-protein kinase SRC inhibitor; Tyrosine-protein kinase HCK inhibitor; Tyrosine-protein kinase Lyn inhibitor; Bcr/Abl fusion protein inhibitor
Targets: 5 genes
UNII: 844ZJE6I55
Aliases: 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile, 4-Anilino-3-quinolinecarbonitrile, 4-Anilinobenzo(g)quinoline-3-carbonitrile, Bosulif, BOSULIF, Bosutinib, Bosutinib Dihydrate, Bosutinib Monohydrate, REDDY-BOSUTINIB, SK-606, SKI 606, SKI-606, SKI606

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (14)

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

System	Code	Label
ATC (WHO)	L01EA04	BOSUTINIB
DIN (Health Canada)	02419149

ABL1 H396P + ABL1 Fusion3
Bosutinib	Acute Lymphoblastic Leukemia	Predictive	D	Does Not Support Resistance	2	submitted	EID4379 In an in vitro kinase study, the recombinant ABL1 H396P mutant kinase did not demonstrate resistance to bosutinib treatment at concentrations of 1μM and 10μM (activity %: 1 and 1) when compared to wil… (full text at CIViC) PMID 19039322 · Remsing Rix et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Does Not Support Resistance	2	accepted	EID4554 In this retrospective study, imatinib-resistant or -intolerant patients, with chronic phase CML and BCR-ABL fusions, were treated with bosutanib monotherapy. Complete hematologic response (CHR) and ma… (full text at CIViC) PMID 21865346 · Cortes et al., 2011 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID4555 In an in vitro study, a Ba/F3 murine cell line stably expressing the H396P mutation in the ABL1 portion of the BCR-ABL1 fusion protein was associated with increased sensitivity to bosutinib treatment … (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic

ABL1 Fusion2
Bosutinib	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	submitted	EID11287 In a phase I/II, open-label trial, 570 patients with Philadelphia chromosome–positive CML were enrolled. Patient cohorts included second-line chronic phase (CP) CML (n = 286), third-/fourth-line CP CM… (full text at CIViC) PMID 24345751 · Kantarjian et al., 2014 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	A	Supports Sensitivity Response	4	submitted	EID11224 536 patients with CML, 487 of which were Philadelphia chromosome-positive were enlisted to a multicentre, open-label phase 3 trial assessing the efficacy and safety of bosutinib. The patients were ran… (full text at CIViC) PMID 29091516 · Cortes et al., 2018 · Open in CIViC	civic

ABL1 F486Y2
Bosutinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	—	submitted	EID4569 In a retrospective study of 118 imatinib-resistant or -intolerant, Philadelphia chromosome BCR-ABL1 fusion positive, chronic myeloid leukemia (chronic phase) patients, no response to dasatinib monothe… (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	—	submitted	EID4570 In an in vitro study, a Ba/F3 murine cell line stably expressing the F486S mutation in the ABL1 portion of the BCR-ABL1 fusion protein was associated with reduced sensitivity to bosutinib treatment (I… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic

ABL1 Non-P-Loop Mutation2
Bosutinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	B	Does Not Support Resistance	3	accepted	EID6337 In this retrospective study, imatinib-resistant or -intolerant patients, with chronic phase CML and BCR-ABL fusions, were treated with bosutanib monotherapy. Among 115 patients with mutational analysi… (full text at CIViC) PMID 21865346 · Cortes et al., 2011 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	B	Does Not Support Resistance	3	accepted	EID6998 This was a retrospective study of dasatinib and/or nilotinib-resistant or -intolerant patients pretreated with imatinib aimed at evaluating the efficacy of bosutanib monotherapy. All patients had chro… (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic

ABL1 P-Loop Mutation2
Bosutinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	B	Does Not Support Resistance	3	accepted	EID6336 In this retrospective study, imatinib-resistant or -intolerant patients, with chronic phase CML and BCR-ABL fusions, were treated with bosutanib monotherapy. Among 115 patients with mutational analysi… (full text at CIViC) PMID 21865346 · Cortes et al., 2011 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	B	Does Not Support Resistance	2	accepted	EID6997 This was a retrospective study of dasatinib and/or nilotinib-resistant or -intolerant patients pretreated with imatinib aimed at evaluating the efficacy of bosutanib monotherapy. All patients had chro… (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic