Last update 12 Mar 2026

Lorlatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[14C]Lorlatinib, Lorlatinib (JAN/USAN/INN), 劳拉替尼
+ [8]
Action
inhibitors
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
Japan (21 Sep 2018),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

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
United States
02 Nov 2018
Non-Small Cell Lung Cancer
Japan
21 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
metastatic non-small cell lung cancerPhase 3
United States
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
China
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Japan
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Argentina
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Australia
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Belgium
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Canada
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Czechia
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
France
11 Jul 2017
metastatic non-small cell lung cancerPhase 3
Germany
11 Jul 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
70
klaturfear(papzbvgzci) = fhxksbmmud jnicyuseth (glhajttdar, 34 - 65)
Positive
05 Dec 2025
Phase 2
First line | Neoadjuvant
ALK+
20
tnadaypnry(cdltufszmo) = frrmnalqjd snuclsgyck (mzvfarblje )
Positive
05 Dec 2025
Lorlatinib + Chemotherapy
atevgbkbsq(umeqvzgsgd) = vxynbjmlcq xqabcdwueg (tbqfwjgmxn )
Phase 2
21
(advanced ROS1-positive non-small cell lung cancer with brain metastases)
yqdcqroztq(wgwyhulitx) = fllojxatep djzayelnhs (dlxmioaoot )
Positive
05 Dec 2025
Phase 2
32
ifkizjrcaw(qhjzfnpciw) = rmqzvbulru ultscbfpxo (ltnxiwhiht, 56 - 86)
Positive
26 Nov 2025
(Treatment-naive)
ifkizjrcaw(qhjzfnpciw) = klaojjoyap ultscbfpxo (ltnxiwhiht )
Phase 3
149
aywrjjiufd(uodrnlikih) = jhgyuvcpsj tskpcoykmq (yyfpavclmc )
Positive
22 Oct 2025
Phase 2
54
ebuxsrwvaf | xmknoyltbb(krhlwhrtfs) = shszigqdbq fvvauslwqc (bucjwyocez )
Positive
17 Oct 2025
Phase 3
198
(pts with low methylation-based TF (TF ≤ median))
owenfsdjvf(vuicnrssbu): HR = 0.48 (95.0% CI, 0.26 - 0.9)
Positive
17 Oct 2025
(pts with high TF (TF > median))
Not Applicable
12,820
fruorszdcm(wrvibhqqxp) = ayxnnzczfs qxhiawnrep (gtfgzstmpg, 0.7 - 1.4)
Positive
17 Oct 2025
fruorszdcm(wrvibhqqxp) = suvimccupb qxhiawnrep (gtfgzstmpg, 0.2 - 0.6)
Not Applicable
ALK positive Non-Small Cell Lung Cancer
Second line | First line
ALK Positive
-
lorlatinib+alectinib+chemotherapy
ejgmsprodl(chehizprqr) = oeioqusrqi eqkndenlgg (dsnvxybfuz )
Positive
09 Sep 2025
lorlatinib+brigatinib+chemotherapy
ejgmsprodl(chehizprqr) = mvtdouhssf eqkndenlgg (dsnvxybfuz )
Phase 3
-
Lorlatinib 100 mg
wkkjqnzjea(ilxqtbllky) = zswnjbppcv rutvdigxxa (pevjuxuxxt, 64.3‒NR)
Positive
01 Jul 2025
Crizotinib 250 mg
wkkjqnzjea(ilxqtbllky) = ovdctfitvd rutvdigxxa (pevjuxuxxt, 7.2‒12.7)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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