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Lurbinectedin · Zepzelca, PM-01183

Small molecule · Cytotoxic, directed at DNA · developed by Jazz

Approved FDA, Jun 2020
JAZZ Developer
2 Registered trials

What is Lurbinectedin?

Lurbinectedin is an alkylating agent that binds guanine residues in the minor groove of DNA, forming adducts that bend the DNA helix and disrupt transcription factor activity and DNA repair pathways. It also inhibits monocyte activity and reduces macrophage infiltration in tumors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Zepzelca, PM-01183, PM-1183
Drug type
Small molecule
Targets
DNA
Mechanism
Cytotoxic, directed at DNA
Pathways
cell cycle perturbation, DNA repair, apoptosis
Therapy area
Oncology
Developer
Jazz (JAZZ)
FDA status
Approved as Zepzelca (June 15, 2020), NDA213702 · FDA label
UNII
2CN60TN6ZS

✅ FDA-approved uses

From the indications section of the FDA label (version of Feb 27, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05091567 Phase 3 Small-Cell Lung Cancer Active not recruiting JAZZ
NCT05229588 Phase 2 Gastrointestinal Malignancies Completed JAZZ

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Small-Cell Lung CancerGastrointestinal Malignancies

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the JAZZ page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.