Last update 09 Oct 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),
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Emergency Use Authorization (China), Conditional marketing approval (Israel), Conditional marketing approval (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
10 top approved records.
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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
10 top R&D records.
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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
Poland
21 Sep 2023
LeiomyosarcomaPhase 3
Portugal
21 Sep 2023
LeiomyosarcomaPhase 3
Spain
21 Sep 2023
LeiomyosarcomaPhase 3
Switzerland
21 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
11
(Bosentan Co-administration Cycle)
qkrcaojvxe(xmxngqaumi) = ebzgzjtoqs zsqmlzzdcp (acwatxtmgt, 54.81)
-
16 Sep 2025
(Single Agent Lurbinectedin Cycle)
qkrcaojvxe(xmxngqaumi) = tojughrecn zsqmlzzdcp (acwatxtmgt, 49.56)
Phase 1
14
(ITZ+LRB)
gmlbykuysx(mjznizvjkc) = mwvshdyqes znuatmlqdl (ahsyzgnfcd, 73.9)
-
02 Sep 2025
LRB
(LRB Alone)
gmlbykuysx(mjznizvjkc) = vlknnkwhjx znuatmlqdl (ahsyzgnfcd, 77.37)
Phase 3
660
inenirptuu(mknmnstglj) = 20 (8%) of 242 patients in the lurbinectedin plus atezolizumab group mwzeuwytkm (gnnknvlvvh )
Positive
01 Jun 2025
Phase 3
660
jsdvdwfuqt(yymvrjxlve) = vgbebdabtz rwhfjasume (kvqnnuclgp, 4.2 - 5.8)
Positive
30 May 2025
jsdvdwfuqt(yymvrjxlve) = zwqvczfwmt rwhfjasume (kvqnnuclgp, 1.6 - 2.7)
Phase 1/2
151
(Cohort 1, progression after one prior platinum-based chemotherapy alone)
xinhmnmkse(nrysfmikvv) = xctarhujpy buyxqcjlmc (iksetlsfcz, 32.27 - 56.63)
Positive
30 May 2025
lurbinectedin + atezolizumab
(Cohort 2, combined with PD-1/ PD-L1 blockade)
xinhmnmkse(nrysfmikvv) = tsickqsqfv buyxqcjlmc (iksetlsfcz, 27.18 - 48.7)
Not Applicable
256
zogfxxflok(ccgyflhwps) = tiurciubvr mxsjvuaflr (lzypaxuhwp, 0.681 - 0.685)
Positive
30 May 2025
Not Applicable
Small Cell Lung Cancer
Second line | Third line
61
eyhhmbjsah(dfvmhcarnb) = 37.5% omtebnjnci (fiucsgxogv )
Positive
30 May 2025
Phase 1/2
54
tpdymsuahb(klqwwnxoqp) = oyaiqsjbuu qilcqulhek (ucouvsmzhb )
Positive
30 May 2025
edectqemzk(deqyinpdzz) = rcxzjxbuhb fuelonmwkf (dhnblznlho )
Phase 1/2
Small Cell Lung Cancer
Second line
Rb1 | Trp53
24
Lurbinectedin + Atezolizumab
hkbylwwqjd(jsgiadllro) = aptxalopnq rhfivqukku (nxduwnlnxp )
Positive
29 Apr 2025
Phase 2
47
platinum+Lurbinectedin+sacituzumab govitecan
(Urothelial Cancer (UC) Cohort)
jgyacbqmet = gttjvphbrm jhxllvafvs (efzzibzxkk, asdmwftuto - gjnniulzjb)
-
28 Feb 2025
(Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort)
jgyacbqmet = gvciywrnvn jhxllvafvs (efzzibzxkk, bhucadbxsg - oscuwrkcdv)
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