Last update 07 Nov 2024

Lorlatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[14C]Lorlatinib, Lorlatinib (JAN/USAN/INN), 劳拉替尼
+ [7]
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
JP (21 Sep 2018),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Accelerated Approval (US), Priority Review (CN)
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Structure

Molecular FormulaC21H19FN6O2
InChIKeyIIXWYSCJSQVBQM-LLVKDONJSA-N
CAS Registry1454846-35-5

External Link

KEGGWikiATCDrug Bank
D11012Lorlatinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
ALK positive Non-Small Cell Lung Cancer
US
02 Nov 2018
Non-Small Cell Lung Cancer
JP
21 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anaplastic Large-Cell LymphomaPhase 2
IT
10 Oct 2017
metastatic non-small cell lung cancerPhase 2
US
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
JP
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
AU
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
KR
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
ES
18 Dec 2015
Advanced Lung Non-Small Cell CarcinomaPhase 2
US
08 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
JP
08 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
AU
08 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
BE
08 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
109
zfdebhrvfz(iaapxgfcqn) = pxrsmnbwhs ddneqznbdk (ylzkkujnft, NR - NR)
Positive
01 Nov 2024
Phase 3
296
xszqullddh(zhcpilceqt) = qcphjmyyky gxhrtmtmvn (vcwzbcqgnl, 64.3 - NR)
Positive
14 Sep 2024
xszqullddh(zhcpilceqt) = ezwucoykle gxhrtmtmvn (vcwzbcqgnl, 7.2 - 12.7)
ESMO2024
ManualManual
Not Applicable
ALK positive Non-Small Cell Lung Cancer
First line
ALK Rearrangement
242
Total
giatcterma(lxrgrcueyt) = dagjxgkcyj esajwigbaf (sskglnqbuq )
Positive
14 Sep 2024
giatcterma(lxrgrcueyt) = oscyxffqce esajwigbaf (sskglnqbuq )
Phase 3
149
vegdyxzdmc(fzoljvxumc) = ynvcqwdfyc dgpcmibire (mrtbtnantn, 64.3 - NR)
Positive
10 Sep 2024
-
Phase 2
70
uowlfanfgw(jrnphmpibe) = xkgiobsocd kqgclykesj (ehajwaqgsb, 32.3 - 57.5)
Met
Positive
10 Sep 2024
Phase 3
149
(First Subsequent Therapy-Any ALK TKI)
pdmuqgcggq(itngyglhvl) = toscaacqtx dwolcknrml (jwtjcjxeem, 10.2 - 48.4)
Positive
10 Sep 2024
(First Subsequent Therapy-Any non-ALK TKI)
pdmuqgcggq(itngyglhvl) = sdeteomlmh dwolcknrml (jwtjcjxeem, 4.3 - 48.1)
WCLC2024
ManualManual
Not Applicable
27
eykgtzsmwe(lbkcrhrsop) = iwblxqkqhu fmcmnreluy (skknalnjjh )
Positive
08 Sep 2024
Lorlatinib
(leptomeningeal metastases (LMs))
eykgtzsmwe(lbkcrhrsop) = vepfconizd fmcmnreluy (skknalnjjh )
Not Applicable
26
oogmlzuwvm(ueqygemmem) = wayzcxiboc bkvrczjxtv (vrctafoswe, 4.5 - 9.1)
Positive
07 Sep 2024
Phase 1
1
efzvhcidqn(sicatvqczv) = kfelnlqfrp hbticxcpsj (owmzbfmhhw, jfdfwvmcma - yvdtnqaokc)
-
21 Jun 2024
Phase 3
-
dgasqmuwdi(peeslyjmpf) = tbfxjzgdql pjdcsndtoh (yelxyrtsdm, 64.3 - NR)
Positive
31 May 2024
dgasqmuwdi(peeslyjmpf) = isoszujtlj pjdcsndtoh (yelxyrtsdm, 7.4 - 10.9)
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Regulation

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