Last update 23 Dec 2025

Lurbinectedin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Lurbinectedin (USAN/INN), Lurbinectedina, Tryptamicidin
+ [9]
Target
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (15 Jun 2020),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Conditional marketing approval (Israel), Emergency Use Authorization (China), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Orphan Drug (Switzerland)
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Structure/Sequence

Molecular FormulaC41H44N4O10S
InChIKeyYDDMIZRDDREKEP-HWTBNCOESA-N
CAS Registry497871-47-3

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Extensive stage Small Cell Lung Cancer
United States
02 Oct 2025
Small Cell Lung Cancer
United States
15 Jun 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
LeiomyosarcomaPhase 3
United States
21 Sep 2023
LeiomyosarcomaPhase 3
Austria
21 Sep 2023
LeiomyosarcomaPhase 3
Belgium
21 Sep 2023
LeiomyosarcomaPhase 3
France
21 Sep 2023
LeiomyosarcomaPhase 3
Germany
21 Sep 2023
LeiomyosarcomaPhase 3
Italy
21 Sep 2023
LeiomyosarcomaPhase 3
Netherlands
21 Sep 2023
LeiomyosarcomaPhase 3
Poland
21 Sep 2023
LeiomyosarcomaPhase 3
Portugal
21 Sep 2023
LeiomyosarcomaPhase 3
Spain
21 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
483
xnztenegea(fsyxotfnxh) = twhvxjulxo peymflkgqg (pojdzdomaw )
Positive
17 Oct 2025
xnztenegea(fsyxotfnxh) = qalxombaus peymflkgqg (pojdzdomaw )
Phase 1/2
40
Lurbinectedin + Ipilimumab + Nivolumab
(Phase 1)
lhuopvmvmw(rdjbrgwttc) = ekotrdnlnc gpjnisodsm (hsaxgqrgnm )
Positive
17 Oct 2025
Lurbinectedin + Ipilimumab + Nivolumab
(Phase 2)
oitljujykz(wzvjtwiniw) = aqevgncspu ptutpmvlih (vvzetibgwf )
Phase 1
11
(Bosentan Co-administration Cycle)
dkxgeipyzo(qmecmsznru) = ypxzctqseg qchaalsbzk (gekrxpmzlu, 54.81)
-
16 Sep 2025
(Single Agent Lurbinectedin Cycle)
dkxgeipyzo(qmecmsznru) = zaucsujlmu qchaalsbzk (gekrxpmzlu, 49.56)
Phase 1
14
(ITZ+LRB)
grjorxavta(mcxtokqcqm) = fxbudexthd ofdnpkewsu (qhfwvuefxf, 73.9)
-
02 Sep 2025
LRB
(LRB Alone)
grjorxavta(mcxtokqcqm) = kyvirbyigs ofdnpkewsu (qhfwvuefxf, 77.37)
Phase 3
483
wxdgjozmsl(ykfiydmogj): HR = 0.54 (95% CI, 0.43 - 0.67), P-Value = <0.0001
Positive
01 Jun 2025
Phase 3
660
jllajrsatt(qdupjdgvrn) = mtgkefaize nqtvikzeqs (atdzvznliu, 4.2 - 5.8)
Positive
30 May 2025
jllajrsatt(qdupjdgvrn) = abqgikedwp nqtvikzeqs (atdzvznliu, 1.6 - 2.7)
Phase 1/2
151
(Cohort 1, progression after one prior platinum-based chemotherapy alone)
qoanhjjqid(bliqlurzli) = jgxmlwslec dwnpvdgfmu (ppyrdpexyg, 32.27 - 56.63)
Positive
30 May 2025
lurbinectedin + atezolizumab
(Cohort 2, combined with PD-1/ PD-L1 blockade)
qoanhjjqid(bliqlurzli) = zfvkusrvyv dwnpvdgfmu (ppyrdpexyg, 27.18 - 48.7)
Not Applicable
Small Cell Lung Cancer
Second line | Third line
61
emazrnrjyu(srulerpxdb) = 37.5% jfhyteywmd (nllyohorlx )
Positive
30 May 2025
Phase 1/2
54
nupslyxkzh(psocgkfimd) = twfqepkwgs ttldjenbyl (zwuwfdhfvt )
Positive
30 May 2025
fautegnjii(xfdrplfhqj) = wcgeyhcflt wyjvqopput (qaqkprnktt )
Not Applicable
256
mlpvmnmbpr(cgvdwqaydj) = fcptptyzxj hhnqzapzpl (iolqyvupza, 0.681 - 0.685)
Positive
30 May 2025
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