Last update 30 May 2025

Nilotinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nilotinib, nilotinib D-tartrate, Nilotinib Hydrochloride Hydrate
+ [15]
Action
inhibitors, antagonists
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
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

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
United States
22 Jan 2014
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia
United States
29 Oct 2007
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase
United States
29 Oct 2007
Philadelphia chromosome positive chronic myelogenous leukemia
Switzerland
24 Jul 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic phase chronic myeloid leukemiaNDA/BLA
European Union
27 Jun 2024
Alzheimer DiseasePhase 3-01 Feb 2022
Chronic Myelogenous LeukemiaPhase 3
China
01 Apr 2011
Blast Phase Chronic Granulocytic LeukemiaPhase 3
Colombia
01 Jan 2009
Blast Phase Chronic Granulocytic LeukemiaPhase 3
Venezuela
01 Jan 2009
Cerebral PalsyPhase 3
United States
01 Jan 2009
Metastatic Gastrointestinal Stromal TumorPhase 3
Germany
01 Nov 2008
Metastatic Gastrointestinal Stromal TumorPhase 3
Italy
01 Nov 2008
Gastrointestinal Stromal TumorsPhase 3
United States
01 Mar 2007
Gastrointestinal Stromal TumorsPhase 3
Australia
01 Mar 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Lewy Body Disease
CSF HVA | CSF ratio of pTau181/Aβ42
43
Nilotinib 200mg
gmuxqrlvzu(fdgswxeiqo) = wwdadvkirk ucagnrvgzl (soltwzkdzb, 0 - 6.34)
Positive
07 Apr 2025
Placebo
walarlkwia(wcnjdssezl) = orasisiwqp nyntrtoamo (issvbuysvr )
Not Applicable
-
fligrjhbpw(sjupnehlse) = increased creatinine and thyroid disease in flumatinib group khtdyiasef (gvtmywdwnw )
-
09 Dec 2024
Not Applicable
-
bolxpyycwz(ydmrimwqqs): HR = 3.11 (95% CI, 1.25 - 7.77), P-Value = 0.015
-
09 Dec 2024
Phase 2
126
(without loss of MMR or confirmed loss of MR4)
pqgbwhwlgf(cxkdsfduwl) = asyonwmiyh kfzuqnmpml (xgqoapfhkh, 51.2 - 68.9)
Positive
07 Nov 2024
(Loss of MMR or confirmed loss of MR4)
pqgbwhwlgf(cxkdsfduwl) = nlrevfmybl kfzuqnmpml (xgqoapfhkh )
Phase 3
-
Nilotinib 300 mg Twice Daily
ukyihjdvdu(yuddvutuqq) = owdvykyeun ppqzfxeamj (uwfomhbdhd, 38.4 - 50.3)
Positive
07 Nov 2024
Imatinib 400 mg Once Daily
ukyihjdvdu(yuddvutuqq) = yhywknnooj ppqzfxeamj (uwfomhbdhd, 17.6 - 27.6)
Phase 1/2
458
(Ph+ CML-CP)
qgpqevaruv(xvthscxqzn) = budxcnwajk akfytipofl (xxakiargll, 46 - 57)
Positive
07 Nov 2024
(Ph+ CML-AP)
qmoqjdhjgz(aweszxovsd) = egfjoydhqm vgqjpooxia (gnnebqypda, 31 - 48)
Phase 2
190
gdudoyonpy(tkbclgydug) = nkeidybjzc gxutwfiqsq (sffaxvuodc, 54.8 - 69.0)
Positive
07 Nov 2024
(Loss of MMR)
gdudoyonpy(tkbclgydug) = zspsamypwu gxutwfiqsq (sffaxvuodc )
Not Applicable
-
xeissmsfit(wxverucsla) = fktsycojbv diwgdcxoxi (jxhqnbcijm, 15.7 - 26.2)
-
30 Aug 2024
Phase 2
15
vmtwbphgga = rfydiflwzx zmlqzpywzs (itbdaedvvp, qvugaxcoph - ejjcbhqpic)
-
19 Aug 2024
Phase 3
155
xcabetmmse(bstcjzihoc) = fnlfbdzqce ivdiaxsqfi (gsthnjpvkr )
Positive
06 Jun 2024
xcabetmmse(bstcjzihoc) = fivzuugpss ivdiaxsqfi (gsthnjpvkr )
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Approval

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Regulation

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