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Drug

Bosutinib

Approved · FDA / EMA
ClassTyrosine-protein kinase ABL inhibitorEmerging researchLate-stage development

Also known as Bosulif.

RxNorm1307619ChEMBLCHEMBL288441ATCL01EA04UNII5018V4AEZ0
1
Research papers
6
Active clinical trials
4
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Bosutinib on Safety, Tolerability, Biomarkers and Clinical Outcomes in Dementia With Lewy Bodies (DLB)

Clinical trial2026-07-10Results posted · ClinicalTrials.gov

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

Approval: BOSUTINIB (ANDA209624)

Regulatory2026-06-12FDA

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Clinical trial2026-06-08Results posted · ClinicalTrials.gov

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial

Clinical trial2026-03-27Results expected Q4 2026 · ClinicalTrials.gov

A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients With Molecular Evidence of Disease

Clinical trial2025-12-18Results posted · ClinicalTrials.gov

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

A Phase I/II Study of Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia", Study ITCC-054/COG-AAML1921

Clinical trial2025-09-18Results expected Q3 2028 · ClinicalTrials.gov

Approval: BOSUTINIB (ANDA209543)

Regulatory2025-05-23FDA

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Clinical trial2025-04-08Results posted · ClinicalTrials.gov

European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia.

Research2020-03-03Leukemia

Approval: Bosulif (EMA)

Regulatory2013-03-27EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Bosutinib
Aliases & brands
Bosulif
RxNorm CUI
1307619
ChEMBL ID
CHEMBL288441
ATC codes
L01EA04
UNII
5018V4AEZ0
Primary mechanism
Tyrosine-protein kinase ABL inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tyrosine-protein kinase ABL1
ABL1 · P00519
INHIBITORTyrosine-protein kinase ABL inhibitor
Proto-oncogene tyrosine-protein kinase Src
SRC · P12931
INHIBITORTyrosine-protein kinase SRC inhibitor
Tyrosine-protein kinase HCK
HCK · P08631
INHIBITORTyrosine-protein kinase HCK inhibitor
Tyrosine-protein kinase Lyn
LYN · P07948
INHIBITORTyrosine-protein kinase Lyn inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-03-27
Latest approval
2026-06-12
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-12Approval
Approval: BOSUTINIB (ANDA209624)
Evidence ↗
2025-05-23Approval
Approval: BOSUTINIB (ANDA209543)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2013-03-27Approval
Approval: Bosulif (EMA)
Indication: Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive… Show full indication

Bosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.• Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

46 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
46
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
3
Recruiting
8
Late-stage (III+)
30
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 46
Phase 117Phase 1 / 25Phase 216Phase 35Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

RecruitingPH IVNovartis Pharmaceuticalsn=3472030

A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS

TerminatedPH IVPfizern=1632020

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Active, not recruitingPH IIINovartis Pharmaceuticalsn=4052031

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

RecruitingPH IIIAscentage Pharma Group Inc.n=2852026

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

CompletedPH IIINovartis Pharmaceuticalsn=2332024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I Trial of Palbociclib and Bosutinib With Fulvestrant in Patients With Metastatic Hormone Receptor Positive and HER2 Negative (HR+ HER2-) Breast Cancer Refractory to an Aromatase Inhibitor and a CDK4/6 Inhibitor (ASPIRE - WI231696)

CompletedPH IGeorgetown Universityn=192025

A Study of Efficacy and Safety of Long-acting Low Dose Ropeginterferon in Patients With Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis: a Randomized Prospective Trial

CompletedPH IISt. Olavs Hospitaln=2122024

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

CompletedPH IIINovartis Pharmaceuticalsn=2332024

A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 4-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY TO COMPARE THE BIOAVAILABILITY OF ORALLY ADMINISTERED BOSUTINIB CAPSULES AND TO ESTIMATE THE EFFECT OF FOOD ON BOSUTINIB CAPSULE

CompletedPH IPfizern=322022

Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors

CompletedPH IIGruppo Italiano Malattie EMatologiche dell'Adulton=652022

Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

CompletedPH INagla Abdel Karimn=62022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Leukemia1
Leading researchers
  • Apperley JF1
  • Baccarani M1
  • Cervantes F1
  • Clark RE1
  • Cortes JE1
  • Deininger MW1
  • Guilhot F1
  • Hehlmann R1
Leading institutions
free-text, unnormalised
  • Almazov National Research Centre1
  • Amsterdam University Medical Center1
  • Centre Hospitalier de Versailles1
  • Centre Hospitalier Universitaire de Poitiers1
  • Centre Léon Bérard1
  • Department Clinical Medicine and Surgery1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dasatinib

Acts on the same molecular target as Bosutinib, with an overlapping disease area.

Shared target1 shared disease1 shared paper
Imatinib Mesylate

Acts on the same molecular target as Bosutinib, with an overlapping disease area.

Shared target1 shared disease1 shared paper
Nilotinib

Studied across the same disease area as Bosutinib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.