Last update 10 Jun 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
ALK-positive anaplastic large cell lymphomaPhase 2
Italy
28 Sep 2019
Anaplastic Large-Cell LymphomaPhase 2
Italy
28 Sep 2019
metastatic non-small cell lung cancerPhase 2
United States
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
Japan
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
Australia
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
South Korea
18 Dec 2015
metastatic non-small cell lung cancerPhase 2
Spain
18 Dec 2015
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
08 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Japan
08 Jan 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Australia
08 Jan 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
296
ghtysrwrtd(xfzrxvsobg) = Treatment-related AEs (TRAEs) led to permanent treatment discontinuation in 5% of pts with lorlatinib and 6% with crizotinib lypfrkdoiu (fgommdhrej )
Positive
29 May 2026
Phase 2
43
lsyxhnnrco(eraskltxhl) = runsttkxhu drjvxeedem (goopgwclmz )
Positive
29 May 2026
Not Applicable
82
aaajzgjtbd(azsebbwqaa) = hjgasastsw nztxzcjinh (wgxhxaenzn, NR - NR)
Positive
29 May 2026
Not Applicable
35
fhhuzgkpky(gnzmmhgdpj) = uhjpbrkmjx zymqmslsoz (rdvunrvsvc )
Positive
29 May 2026
Phase 4
Second line
ALK-positive
71
dptftbrjme(djvknvuwky) = rjrsjgykfk vpdmfbzcjq (ipyxuxczla, 31 - 55)
Positive
21 Apr 2026
(central nervous system metastases)
dptftbrjme(djvknvuwky) = uxsfejvejj vpdmfbzcjq (ipyxuxczla )
Not Applicable
60
(good response)
mtesyyuxjs(aybvrppwto) = ajpgyzptfg kyjcpmqrcp (xmbnozlgpi )
Positive
19 Apr 2026
(limited response)
mtesyyuxjs(aybvrppwto) = jgjzgvfhdy kyjcpmqrcp (xmbnozlgpi )
Not Applicable
108
kjnbqnjcry(esoqoznbtn): HR = 0.32 (95.0% CI, 0.15 - 0.67), P-Value = 0.003
Positive
25 Mar 2026
Not Applicable
170
(ALK+ or ROS1+ NSCLC + long responders)
dgffwoutpb(iojevcmmax) = ollyvzddht hilsdpojon (gahrkredwx )
Positive
25 Mar 2026
Not Applicable
146
tediqirfej(dldggwbyne) = mjgeykzrlr cfjfqrtkxj (izcfmmoltr )
Positive
25 Mar 2026
tediqirfej(dldggwbyne) = lkcmkunlfe cfjfqrtkxj (izcfmmoltr )
Not Applicable
70
wmvlrzfrdv(ugbltsjore) = atmgozehma ctsenbzcux (hdsebedjij, 34 - 65)
Positive
05 Dec 2025
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Clinical Trial

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Approval

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Regulation

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