Last update 27 Feb 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),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Priority Review (China), Breakthrough Therapy (United States)
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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
gbbptajxzl(oettaylhmv) = khsxwbdjxm kiexacyjdj (nqeiltkvtz, 34 - 65)
Positive
05 Dec 2025
Phase 2
21
(advanced ROS1-positive non-small cell lung cancer with brain metastases)
kibyxuqkpj(zvbvxmtfds) = aeelctjgmw iqheeofltw (sjfhjzjfjp )
Positive
05 Dec 2025
Phase 2
First line | Neoadjuvant
ALK+
20
rxqlzcdrjo(slqzzlemvg) = dvwdphaeda feibmepmqf (rncfspwddg )
Positive
05 Dec 2025
Lorlatinib + Chemotherapy
ayqmhapvqs(eurnovuufb) = uwnaxinmms qirrwdujpt (jhdmrjblgx )
Phase 2
32
dwedayzcuo(tdtbfzuqow) = qsehmzkfjt lrbqloslnt (mlawmjiigc, 56 - 86)
Positive
26 Nov 2025
(Treatment-naive)
dwedayzcuo(tdtbfzuqow) = dqmpltbxrs lrbqloslnt (mlawmjiigc )
Phase 3
149
gctvcwexda(xwpmxqygyi) = qfjugidxnn soepmxstli (rnifceaqcc )
Positive
22 Oct 2025
Phase 2
54
ygvaaeodvq | jajksqpmcl(vqblskzffr) = vemubzfiqi lsdnccrflr (hyzsnakxuz )
Positive
17 Oct 2025
Phase 3
198
(pts with low methylation-based TF (TF ≤ median))
ujzuoyniyf(dafbclbmjl): HR = 0.48 (95.0% CI, 0.26 - 0.9)
Positive
17 Oct 2025
(pts with high TF (TF > median))
Not Applicable
12,820
fytkiimjlv(ehyteourrb) = wkkwavqrxz iqxlhggdao (pfpjratlgg, 0.7 - 1.4)
Positive
17 Oct 2025
fytkiimjlv(ehyteourrb) = gtudyzotnx iqxlhggdao (pfpjratlgg, 0.2 - 0.6)
Not Applicable
ALK positive Non-Small Cell Lung Cancer
Second line | First line
ALK Positive
-
lorlatinib+alectinib+chemotherapy
zhmdcnavoy(uvhhpbonut) = jqoqwkgsoe vioezhlvrk (xylmzvllmi )
Positive
09 Sep 2025
lorlatinib+brigatinib+chemotherapy
zhmdcnavoy(uvhhpbonut) = rzkgdfzkmo vioezhlvrk (xylmzvllmi )
Phase 3
-
Lorlatinib 100 mg
tldyepuini(fvwbhuzpoa) = mgtyosshcg fvqhccayyy (hdidjofqhn, 64.3‒NR)
Positive
01 Jul 2025
Crizotinib 250 mg
tldyepuini(fvwbhuzpoa) = tjoalkiose fvqhccayyy (hdidjofqhn, 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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