Last update 14 Sep 2025

Bosutinib Monohydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BOSUTINIB, bosutinib (as monohydrate), Bosutinib Hydrate
+ [12]
Action
inhibitors
Mechanism
Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), SRC inhibitors(Tyrosine-protein kinase SRC inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Special Review Project (China), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC26H31Cl2N5O4
InChIKeyBXPOSPOKHGNMEP-UHFFFAOYSA-N
CAS Registry918639-08-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Myelogenous Leukemia
Japan
26 Sep 2014
Ductus Arteriosus, Patent
Australia
29 Apr 2014
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia
European Union
27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia
Iceland
27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia
Liechtenstein
27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia
Norway
27 Mar 2013
Aggressive-Phase Chronic Myelocytic Leukemia
European Union
27 Mar 2013
Aggressive-Phase Chronic Myelocytic Leukemia
Iceland
27 Mar 2013
Aggressive-Phase Chronic Myelocytic Leukemia
Liechtenstein
27 Mar 2013
Aggressive-Phase Chronic Myelocytic Leukemia
Norway
27 Mar 2013
Blast Phase Chronic Granulocytic Leukemia
European Union
27 Mar 2013
Blast Phase Chronic Granulocytic Leukemia
Iceland
27 Mar 2013
Blast Phase Chronic Granulocytic Leukemia
Liechtenstein
27 Mar 2013
Blast Phase Chronic Granulocytic Leukemia
Norway
27 Mar 2013
Chronic phase chronic myeloid leukemia
European Union
27 Mar 2013
Chronic phase chronic myeloid leukemia
Iceland
27 Mar 2013
Chronic phase chronic myeloid leukemia
Liechtenstein
27 Mar 2013
Chronic phase chronic myeloid leukemia
Norway
27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis
European Union
27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis
Iceland
27 Mar 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic leukemiaPhase 2
Spain
24 Feb 2021
Chronic leukemiaPhase 2
Spain
24 Feb 2021
Amyotrophic Lateral SclerosisPhase 2
Japan
19 Mar 2019
Recurrent GlioblastomaPhase 2
United States
01 Apr 2011
Polycystic Kidney, Autosomal DominantPhase 2
United States
01 Dec 2010
Polycystic Kidney, Autosomal DominantPhase 2
Australia
01 Dec 2010
Polycystic Kidney, Autosomal DominantPhase 2
Canada
01 Dec 2010
Polycystic Kidney, Autosomal DominantPhase 2
Czechia
01 Dec 2010
Polycystic Kidney, Autosomal DominantPhase 2
Hungary
01 Dec 2010
Polycystic Kidney, Autosomal DominantPhase 2
Italy
01 Dec 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
skuhygctpe(jqlgbltest) = byqaizxtjn pjhizhezhr (vrnspbhgaw, 90 - 100%)
Positive
14 May 2025
Phase 2
45
oidplrgrlt(wfleafevqr) = All pts had ≥1 any grade treatment emergent adverse event (TEAE), occuring a median of 15 days after starting bosutinib (range: 1 - 225 days) dubauvkyxu (wgmroiakxi )
Positive
07 Dec 2024
Nilotinib
Phase 4
Chronic Myelogenous Leukemia
Philadelphia Chromosome
163
Bosutinib 500 mg QD
rzngetfttw(oekrmmqsru) = lafvjxgraq onhbybnueq (djapljfcbg, 63.9 - 78.9)
Positive
01 Oct 2024
Phase 1
-
32
(Treatment A: Bosutinib 1*100 mg Capsule Fed)
zqlckdvmjt(azaavlipcb) = mzgwtycrfq oberryqhaq (kgbkolvker, 32)
-
20 Sep 2024
(Treatment B: Bosutinib 4*25 mg Capsule Fed)
zqlckdvmjt(azaavlipcb) = ukpymgmkjr oberryqhaq (kgbkolvker, 39)
Phase 2
35
wqilkpofjb(suvpuvefvb) = lihgcogkax tghfrhzdzi (cfnbfxtlwe, 5.2 - 23.2)
Met
Positive
14 May 2024
Phase 4
156
Bosutinib500mg once daily
vhdtuojycr(srjmrtabnu) = euvknozooy dvwjdfjyqu (dkwlwfhdcu )
Positive
01 Apr 2024
Bosutinib 500mg once daily
(dasatinib/nilotinib-resistant)
vhdtuojycr(srjmrtabnu) = cubhqzvyjc dvwjdfjyqu (dkwlwfhdcu )
Phase 1/2
9
lcoqqctxjl = cbbkiigauh qnexgmvjsb (klrumhcgap, jphrnqaqgc - uftzdaqtxa)
-
12 Mar 2024
Phase 1
27
Bosutinib 300-400 mg/m2 once daily
wanqrarbog(tihxwzuaod) = kqontdotgb ytyjiydaiv (wjesrrqwmz )
Positive
01 Mar 2024
Bosutinib 300 mg/m2 once daily
gzzftnfbfm(xkicmsinaz) = uticnoqqxu iznoeikxuv (ndllvgitkw )
Phase 2
35
jexufbcekm(gjkrfgkiur) = wxqsujswaz brgwdnfqno (xijliglnju )
-
10 Dec 2023
Phase 1/2
-
(R/I CP Ph+ CML)
hknnlphsnr(vilkxgehoy) = qhvvzmfhxg qxeonmpzvp (wfgkrpaihj, 59.0 - 91.7)
Positive
26 Sep 2023
(ND CP Ph+ CML)
hknnlphsnr(vilkxgehoy) = fgkonmgwnr qxeonmpzvp (wfgkrpaihj, 47.8 - 88.7)
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