Drugs / Lurbinectedin
Lurbinectedin
also known as
PM01183 · Zepzelca · Lurbinectedina · Lurbinectedine · PM-1183 · Tryptamicidin · Zepsyre
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zepzelca | — | 2026-05-29 | europa.eu ↗ |
| Label expansion | US (FDA) | ZEPZELCA | — | 2025-10-02 | fda.gov ↗ |
| Approved | US (FDA) | ZEPZELCA | — | 2020-06-15 | fda.gov ↗ |
Trials 56 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05636111 | Jul 2023 → Dec 2026 expected | ovarian cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05244239 | Jul 2022 → Jul 2026 overdue | small cell lung carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT05101265 | Mar 2021 → Jun 2025 | neoplasm | PharmaMar | Unknown | No outcome recorded |
| Phase 1 | NCT04638491 | Nov 2020 → Nov 2023 | neoplasm | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04610658 | Nov 2020 → Mar 2023 | small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 1 | NCT01980667 | Jul 2014 → Jan 2017 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01831089 | Sep 2013 → Jul 2016 | breast cancer, head and neck carcinoma, non-small cell lung carcinoma, ovarian cancer +1 | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT02210364 | Apr 2013 → Oct 2016 | breast cancer, colorectal cancer, malignant pancreatic neoplasm | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01405391 | Nov 2011 → Jan 2016 | — | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01970540 | May 2011 → Aug 2017 | endometrium adenocarcinoma, small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01314599 | May 2011 → Jul 2015 | acute leukemia | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT01970553 | May 2011 → Oct 2013 | — | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT00877474 | Mar 2009 → Jun 2011 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1/214 trials | ||||||
| Phase 1/2 | NCT07153055 | Aug 2026 → Apr 2029 expected | small cell lung carcinoma | Misty Shields | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07141771 | Dec 2025 → Jun 2030 expected | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06217536 | Oct 2024 → May 2026 | soft tissue sarcoma | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06385548 | May 2024 | endometrial cancer | Vall d'Hebron Institute of Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05918640 | Jul 2023 → Jul 2027 expected | Ewing sarcoma, childhood malignant neoplasm, desmoplastic small round cell tumor | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05876715 | Jun 2023 → Jun 2026 overdue | soft tissue sarcoma | ERLINDA M GORDON | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05734066 | May 2023 → Jan 2028 expected | Ewing sarcoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05099666 | Feb 2022 → Jul 2026 overdue | leiomyosarcoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05042934 | Sep 2021 → Aug 2022 | Ewing sarcoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04802174 | Jun 2021 → Dec 2025 overdue | small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04358237 | Sep 2020 → Sep 2023 | small cell lung carcinoma | Antonio Calles Blanco | Completed | No outcome recorded |
| Phase 1/2 | NCT04253145 | Dec 2019 → May 2025 | small cell lung carcinoma | Fundacion Oncosur | Unknown | No outcome recorded |
| Phase 1/2 | NCT02611024 | May 2016 → Jul 2025 | colorectal carcinoma, digestive system neuroendocrine neoplasm, endometrial carcinoma, gastric carcinoma +6 | PharmaMar | Completed | No outcome recorded |
| Phase 1/2 | NCT02684318 | Jul 2015 → Jul 2019 | breast cancer, cancer of unknown primary site, endometrial cancer, ovarian cancer | Poveda, Andrés, M.D. | Unknown | No outcome recorded |
| Phase 221 trials | ||||||
| Phase 2 | NCT07258147 | Oct 2026 → Dec 2027 expected | small cell lung carcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07459634 | Aug 2026 → Jan 2028 expected | small cell lung carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07640932 | Jun 2026 → Apr 2027 expected | small cell lung carcinoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06501976 | Dec 2025 → Dec 2026 expected | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07328425 | Nov 2025 → Oct 2030 expected | desmoplastic small round cell tumor | Italian Sarcoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07121478 | Sep 2025 → Mar 2027 expected | pancreatic neuroendocrine tumor | National Cancer Center, Korea | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06497530 | Dec 2024 → Dec 2026 expected | small cell lung carcinoma | Guangzhou Institute of Respiratory Disease | Recruiting | No outcome recorded |
| Phase 2 | NCT06228066 | Jun 2024 → Sep 2027 expected | bladder small cell carcinoma, neuroendocrine neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05572476 | Oct 2023 → May 2024 | small cell lung carcinoma | Institut Bergonié | Withdrawn | No outcome recorded |
| Phase 2 | NCT05574504 | May 2023 → Nov 2026 | metastatic malignant neoplasm, urothelial carcinoma | AdventHealth | Withdrawn | No outcome recorded |
| Phase 2 | NCT05800587 | Feb 2023 → Aug 2028 expected | non-small cell lung carcinoma, small cell lung carcinoma | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05578326 | Oct 2022 → Dec 2026 expected | small cell lung carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05229588 | Jun 2022 → Aug 2025 | digestive system cancer | HonorHealth Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT05126433 | Mar 2022 → Dec 2023 | metastatic neoplasm, neuroendocrine carcinoma, urothelial carcinoma | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04607954 | Dec 2020 → Sep 2026 expected | small cell lung carcinoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03213301 | Sep 2017 → Jun 2021 | malignant pleural mesothelioma | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02454972 | Aug 2015 → Sep 2020 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT02451007 | Aug 2015 → Aug 2016 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT02448537 | Aug 2015 → Feb 2017 | sarcoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01951157 | Sep 2013 → Nov 2016 | non-small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT01525589 | Jun 2012 → Oct 2018 | breast cancer | PharmaMar | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06801834 | Apr 2025 → Oct 2029 expected | small cell lung carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT06496048 | Sep 2024 → Dec 2027 expected | small cell lung carcinoma | Luye Pharma Group Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06088290 | Sep 2023 → Aug 2029 expected | leiomyosarcoma | PharmaMar | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05153239 | Jul 2022 → Apr 2026 | small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 3 | NCT05091567 | Nov 2021 → Jul 2024 overdue | small cell lung carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02566993 | Aug 2016 → Feb 2020 | small cell lung carcinoma | PharmaMar | Completed | No outcome recorded |
| Phase 3 | NCT02421588 | May 2015 → Oct 2018 | ovarian cancer | PharmaMar | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04291937 | — | small cell lung carcinoma | Jazz Pharmaceuticals | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05072106 Comparator | Jan 2021 → Jan 2022 | neoplasm | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT05063318 Comparator | Oct 2020 → Apr 2022 | cancer | PharmaMar | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06681220 Comparator | Feb 2026 → Dec 2029 expected | small cell lung carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05652686 Background | Sep 2023 → Dec 2027 expected | digestive system neuroendocrine neoplasm, large cell neuroendocrine carcinoma, prostate neuroendocrine neoplasm, small cell lung carcinoma | Phanes Therapeutics | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07155174 Background | Nov 2025 → Apr 2029 expected | small cell lung carcinoma | AbbVie | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07625644 Comparator | Jun 2026 → Jan 2030 expected | small cell lung carcinoma | SystImmune Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07365241 Comparator | Apr 2026 → Sep 2030 expected | small cell lung carcinoma | AbbVie | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07218146 Comparator | Nov 2025 → Jun 2028 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06203210 Comparator | May 2024 → Apr 2027 expected | small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT05740566 Comparator | May 2023 → Jan 2025 overdue | small cell lung carcinoma | Amgen | Active not recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-10-03 | Roche Global Development | FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer roche.com ↗ |
| 2025-06-03 | Roche Global Development | Roche’s Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer roche.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lurbinectedin | “This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer.” PMID 30240327 ↗ Sep 201860“PURPOSE: Lurbinectedin (PM01183) binds covalently to DNA and has broad activity against tumor cell lines.” PMID 24563480 ↗ Feb 2014 “Topotecan, Lurbinectedin, or Amrubicin” NCT07218146 ↗ “Lurbinectedin (PM01183)” NCT01831089 ↗ |
| Known as | Lurbinectedina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Lurbinectedine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | PM-1183 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | PM01183 | “This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer.” PMID 30240327 ↗ Sep 201818“lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01980667 ↗ “lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01970540 ↗ “Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients” NCT02421588 ↗ “lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion” NCT02451007 ↗ “Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors” NCT05063318 ↗ “lurbinectedin (PM01183) 1 mg and 4 mg vials” NCT02210364 ↗ “Lurbinectedin (PM01183) for Injection” NCT04638491 ↗ “Drug: Lurbinectedin (PM01183)” NCT02566993 ↗ “Drug: Lurbinectedin (PM01183)” NCT01951157 ↗ “lurbinectedin (PM01183)” NCT02454972 ↗ “Lurbinectedin (PM01183)” NCT01831089 ↗ “lurbinectedin (PM01183)” NCT01970553 ↗ |
| Known as | Tryptamicidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Zepsyre | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297516 ↗ |
| Known as | Zepzelca | “A Phase II Pilot Clinical Trial of Lurbinectedin (Zepzelca™ PM01183) in Patients With Gastrointestinal Malignancies With DNA Repair Mutations” NCT05229588 ↗1“Lurbinectedin 4 MG Injection [Zepzelca]” NCT07121478 ↗ |
| Action | Inhibit | “a selective inhibitor of active transcription of protein-coding genes” PMID 30240327 ↗ Sep 2018 |
| Modality | Other / unclassified | “Lurbinectedin is in a class of medications called alkylating agents.” NCT04607954 ↗ |
| Route | Intravenous | “PM01183 administered every three weeks intravenously (i.v.) over one hour” NCT00877474 ↗ |