ZEPZELCA (lurbinectedin)
ZEPZELCA is indicated for the treatment of Small Cell Lung Cancer; Metastatic Small Cell Lung Cancer.
How ZEPZELCA Works
Lurbinectedin is an alkylating drug that binds to guanine residues within the minor groove of DNA, forming adducts that bend the DNA helix toward the major groove. This structural deformation triggers a cascade of events that interferes with the activity of DNA-binding proteins, including specific transcription factors and DNA repair pathways, resulting in cell cycle perturbation and eventual apoptosis. Beyond its direct cytotoxic effects, lurbinectedin has been shown to inhibit human monocyte activity and reduce macrophage infiltration in tumor microenvironments.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-15
- Patent Cliff
- 2040
- Revenue
- $90M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ZEPZELCA Approval History
What ZEPZELCA Treats
2 indicationsZEPZELCA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Small Cell Lung Cancer
- Metastatic Small Cell Lung Cancer
ZEPZELCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZEPZELCA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEPZELCA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEPZELCA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07155174 SEZanne | M24-633 2024-517490-24 | Ph 2 | recruiting | A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer |
| NCT05153239 | PM1183-C-008-21 | Ph 3 | completed | Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) |
| NCT07459634 | JZP712-203 2025-524566-13-00 | Ph 2 | not yet recruiting | A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC |
| NCT06088290 SaLuDo | PM1183-C-010-22 2022-502975-45 | Ph 3 | active not recruiting | Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) |
| NCT05099666 | 21-437 | Ph 1, Ph 2 | active not recruiting | Lurbinectedin + Doxorubicin In Leiomyosarcoma |
| NCT07328425 ISG-TULIPS | ISG-TULIPS 2024-519261-21-00 | Ph 2 | recruiting | Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS |
| NCT05918640 LiFFT | 23-020814 | Ph 1, Ph 2 | recruiting | Lurbinectedin in FET-Fused Tumors |
| NCT04607954 | MC1923 20-001531 | Ph 2 | active not recruiting | Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer |
| NCT05578326 | LCCC2117 | Ph 2 | recruiting | Study of Trilaciclib and Lurbinectidin |
| NCT06228066 | 10001523 001523-C | Ph 2 | recruiting | Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER) |
| NCT04802174 | 10000176 000176-C | Ph 1, Ph 2 | active not recruiting | Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers |
| NCT06681220 Relapsed SCLC | SPLP-002-24S 14094144/CX002801-01A1 | Ph 1, Ph 2 | recruiting | Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC |
| NCT05091567 IMforte results posted | GO43104 2023-503868-16-00 | Ph 3 | active not recruiting | A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer |
| NCT06203210 IDeate-Lung02 | DS7300-188 2023-509628-16-00, 2031230631 | Ph 3 | recruiting | A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer |
| NCT05734066 | JZP712-101 | Ph 1, Ph 2 | recruiting | Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma |
| NCT07365241 | M23-384 2025-523819-11 | Ph 3 | not yet recruiting | A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer |
| NCT05636111 | 2022-0231 NCI-2022-10037 | Ph 1 | recruiting | Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer |
| NCT05740566 DeLLphi-304 results posted | 20210004 | Ph 3 | active not recruiting | Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer |
| NCT07153055 LOTS | CTO-IUSCCC-0891 | Ph 1, Ph 2 | not yet recruiting | Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer |
| NCT05244239 | STUDY00003528 NCI-2021-12410, STUDY00003528 | Ph 1 | recruiting | Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer |
| NCT05072106 results posted | PM1183-A-019-20 | Ph 1 | completed | Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors |
| NCT07141771 | UM-SCLC | Ph 1, Ph 2 | not yet recruiting | An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing |
| NCT02611024 | PM1183-A-014-15 | Ph 1, Ph 2 | completed | Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors |
| NCT04358237 LUPER | MedOPP300 | Ph 1, Ph 2 | completed | Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. |
| NCT05800587 | 22-1052 TH-214 | Ph 2 | recruiting | Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer |
| NCT06385548 LiDer | VHIO21001 | Ph 1, Ph 2 | withdrawn | Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer |
| NCT05126433 JAZZ EMERGE201 results posted | JZP712-201 | Ph 2 | terminated | Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors |
| NCT06496048 | LY01017/CT-CHN-302 | Ph 3 | recruiting | Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC |
| NCT06217536 | 23872 NCI-2024-00107 | Ph 1, Ph 2 | withdrawn | Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas |
| NCT06501976 | NCC4493 | Ph 2 | not yet recruiting | An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy |
| NCT06497530 | CROC-24-02 | Ph 2 | not yet recruiting | Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC |
| NCT05876715 LINNOVATE | SOC-2310 | Ph 1, Ph 2 | recruiting | LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma |
| NCT04610658 | MCC-20332 | Ph 1 | terminated | Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC |
| NCT05042934 | 2017-0607 NCI-2019-01258, 2017-0607 | Ph 1, Ph 2 | withdrawn | Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma |
| NCT03213301 | SAKK 17/16 2017-001016-11 | Ph 2 | completed | Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZEPZELCA FDA Label Details
Indications & Usage
FDA Label (PDF)ZEPZELCA is indicated for the treatment of Small Cell Lung Cancer; Metastatic Small Cell Lung Cancer.
ZEPZELCA Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZEPZELCA
Revenue Insights
- • Q4-2025: $90M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 5 active patents
Trial Analysis
- • 37 total trials
- • Stage: Growth
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment