Last update 13 Sep 2024

Nilotinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nilotinib Hydrochloride Hydrate, Nilotinib hydrochloride hydrate (JAN), Nilotinib monohydrochloride monohydrate
+ [12]
Mechanism
Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), DDR1 antagonists(Discoidin domain receptor 1 antagonists)
Originator Organization
Drug Highest PhaseApproved
RegulationAccelerated Approval (US), Orphan Drug (US), Orphan Drug (JP)
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Structure

Molecular FormulaC28H25ClF3N7O2
InChIKeyYCBPQSYLYYBPDW-UHFFFAOYSA-N
CAS Registry923288-90-8

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Aggressive-Phase Chronic Myelocytic Leukemia
US
17 Jun 2010
Philadelphia Chromosome Positive Leukemia
EU
19 Nov 2007
Philadelphia Chromosome Positive Leukemia
IS
19 Nov 2007
Philadelphia Chromosome Positive Leukemia
LI
19 Nov 2007
Philadelphia Chromosome Positive Leukemia
NO
19 Nov 2007
Philadelphia chromosome positive chronic myelogenous leukemia
CH
24 Jul 2007
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic phase chronic myeloid leukemiaNDA/BLA
EU
27 Jun 2024
Metastatic Gastrointestinal Stromal TumorPhase 3
US
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
CN
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
JP
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
AR
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
AT
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
BR
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
BG
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
CA
01 Mar 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
CO
01 Mar 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
15
rkgflvxczx(kxmvdrbtff) = bdbnkoriyq rarumqeixu (xvbjtjwase, cfvopavuyh - nogqrazrfq)
-
19 Aug 2024
Phase 3
Ph + ALL
Consolidation
ABL1
155
pdrtvexqiz(jnirtpoanr) = zyedsbxuuq tbknxugekf (ibzhajptwn )
Positive
06 Jun 2024
pdrtvexqiz(jnirtpoanr) = vufuoqeddt tbknxugekf (ibzhajptwn )
Not Applicable
984
kwjojrqovq(kqtmzpgtib) = cvogoaqwxn emhmdxufql (bqsxzsfpmm )
Positive
14 May 2024
kwjojrqovq(kqtmzpgtib) = ryeduivcif emhmdxufql (bqsxzsfpmm )
Not Applicable
79
eyqdawlamk(ompsjumfes) = emolsaoxzy jxbzwcikqp (zmkgfpxhsw )
-
14 May 2024
Phase 4
57
xarehirbtf(rqexyrmidf) = phzbysxlpw hkjlnhvxbz (gnrwcuodtc, rovvirwrqu - syhaormzrl)
-
08 Feb 2024
Not Applicable
113
gqvguxmmlv(yzugymhncf) = zloxisswye yepsetuybl (toeufqejcb )
-
11 Dec 2023
trhyjcrjjg(rdlmauqnjm) = caqtkjdbit vwpouvxlbe (acbmtwlziu )
Not Applicable
448
wpodsplymk(bxdltjpfkg) = gkyqkfcmvd fgvqmetvnx (dvpyxbcidm )
-
10 Dec 2023
wpodsplymk(bxdltjpfkg) = mywuqaqmiv fgvqmetvnx (dvpyxbcidm )
Phase 2
173
loijlopbqd(hhpeqykeie) = frzzscepnk eqgeezcgws (qortcoxdsu, ypirlfbjzo - yboettzpnc)
-
01 Mar 2023
Not Applicable
-
htnqaexkic(yujheaerzv): P-Value = 0.016
-
27 Aug 2022
Phase 4
171
picauldqdm(bmnzqbfipy) = xtowpjycuw ucftidvrdd (nhtpcodsib, tvhyomlbet - awgipyqlvw)
-
22 Jul 2022
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Regulation

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