Lurbinectedin
drugOn this page
Also known as LurbinectedinaLurbinectedinePM-01183PM-1183Pm01183PM1183TryptamicidinZepsyreZepzelca
Summary
Lurbinectedin (CHEMBL4297516) is an approved small molecule (ATC L01XX69); indicated across 19 conditions including neoplasm and small cell lung carcinoma.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: L01XX69
- Indications: 19 conditions
- Clinical trials: 56
- Chemistry: 784.9 Da · C41H44N4O10S
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297516 |
| Name | Lurbinectedin |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 57327016 |
| ATC | L01XX69 |
| Molecular formula | C41H44N4O10S |
| Molecular weight | 784.9 |
| InChIKey | YDDMIZRDDREKEP-HWTBNCOESA-N |
SMILES: CC1=CC2=C([C@@H]3[C@@H]4[C@H]5C6=C(C(=C7C(=C6[C@@H](N4[C@H]([C@H](C2)N3C)O)COC(=O)[C@@]8(CS5)C9=C(CCN8)C2=C(N9)C=CC(=C2)OC)OCO7)C)OC(=O)C)C(=C1OC)O
IUPAC name: [(1R,2R,3R,11S,12S,14R,26R)-5,12-dihydroxy-6,6’-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1’-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22-yl] acetate
Also known as: Lurbinectedin, Lurbinectedina, Lurbinectedine, PM-01183, PM-1183, Pm01183, PM01183, PM1183, Tryptamicidin, Zepsyre, Zepzelca, LURBINECTEDIN
Patent coverage: 277 distinct patent families (712 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
19 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| small cell lung carcinoma | 4 | MONDO:0008433 | EFO:0000702 |
| ovarian carcinoma | 3 | MONDO:0005140 | EFO:0001075 |
| ovarian cancer | 3 | MONDO:0008170 | MONDO:0008170 |
| sarcoma | 2 | MONDO:0005089 | EFO:0000691 |
| malignant pleural mesothelioma | 2 | MONDO:0005112 | EFO:0000770 |
| mesothelioma | 2 | MONDO:0005065 | EFO:0000588 |
| non-small cell lung carcinoma | 2 | MONDO:0005233 | EFO:0003060 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| leiomyosarcoma | 2 | MONDO:0005058 | EFO:0000564 |
| soft tissue sarcoma | 2 | MONDO:0018078 | EFO:1001968 |
| gastric carcinoma | 1 | MONDO:0004950 | EFO:0000178 |
| leukemia | 1 | MONDO:0005059 | EFO:0000565 |
| endometrial carcinoma | 1 | MONDO:0002447 | EFO:1001512 |
| carcinoid tumor | 1 | MONDO:0005369 | MONDO:0024503 |
| Ewing sarcoma | 1 | MONDO:0012817 | EFO:0000174 |
| colorectal carcinoma | 1 | MONDO:0024331 | EFO:1001951 |
| endometrium neoplasm | 1 | MONDO:0021251 | MONDO:0011962 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 56.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 16 |
| PHASE1/PHASE2 | 14 |
| PHASE1 | 14 |
| PHASE3 | 9 |
| Not specified | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05091567 | PHASE3 | 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 |
| NCT05740566 | PHASE3 | ACTIVE_NOT_RECRUITING | Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer |
| NCT06088290 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) |
| NCT06203210 | PHASE3 | RECRUITING | A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer |
| NCT06496048 | PHASE3 | RECRUITING | Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC |
| NCT07365241 | PHASE3 | 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 |
| NCT02421588 | PHASE3 | COMPLETED | Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients |
| NCT02566993 | PHASE3 | COMPLETED | Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer |
| NCT05153239 | PHASE3 | 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) |
| NCT04607954 | PHASE2 | ACTIVE_NOT_RECRUITING | Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer |
| NCT04802174 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers |
| NCT05099666 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Lurbinectedin + Doxorubicin In Leiomyosarcoma |
| NCT05578326 | PHASE2 | RECRUITING | Study of Trilaciclib and Lurbinectidin |
| NCT05734066 | PHASE1/PHASE2 | RECRUITING | Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma |
| NCT05800587 | PHASE2 | RECRUITING | Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer |
| NCT05876715 | PHASE1/PHASE2 | RECRUITING | LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma |
| NCT05918640 | PHASE1/PHASE2 | RECRUITING | Lurbinectedin in FET-Fused Tumors |
| NCT06228066 | PHASE2 | RECRUITING | Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER) |
| NCT06497530 | PHASE2 | NOT_YET_RECRUITING | Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC |
| NCT06501976 | PHASE2 | NOT_YET_RECRUITING | An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy |
| NCT06681220 | PHASE1/PHASE2 | RECRUITING | Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC |
| NCT07141771 | PHASE1/PHASE2 | NOT_YET_RECRUITING | An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing |
| NCT07153055 | PHASE1/PHASE2 | NOT_YET_RECRUITING | Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer |
| NCT07155174 | PHASE2 | 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 |
| NCT07328425 | PHASE2 | RECRUITING | Clinical Study in Adult and Young Adult Patients With Advanced Desmoplastic Small Round Cell Tumor (DSRCT) ISG-TULIPS |
| NCT07459634 | PHASE2 | NOT_YET_RECRUITING | A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC |
| NCT01525589 | PHASE2 | COMPLETED | A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer |
| NCT01951157 | PHASE2 | COMPLETED | A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients |
| NCT02448537 | PHASE2 | COMPLETED | A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas |
| NCT02451007 | PHASE2 | COMPLETED | Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors |
| NCT02454972 | PHASE2 | COMPLETED | Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors |
| NCT02611024 | PHASE1/PHASE2 | COMPLETED | Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors |
| NCT02684318 | PHASE1/PHASE2 | UNKNOWN | Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors |
| NCT03213301 | PHASE2 | COMPLETED | Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. |
| NCT04358237 | PHASE1/PHASE2 | COMPLETED | Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. |
| NCT05042934 | PHASE1/PHASE2 | WITHDRAWN | Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma |
| NCT05126433 | PHASE2 | TERMINATED | Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors |
| NCT06217536 | PHASE1/PHASE2 | WITHDRAWN | Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas |
| NCT06385548 | PHASE1/PHASE2 | WITHDRAWN | Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer |
| NCT05244239 | PHASE1 | RECRUITING | Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 6 variant annotation(s) for this drug (gene-keyed; see PharmGKB).
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: neoplasm, small cell lung carcinoma, ovarian carcinoma, ovarian cancer