Drugs / Lurbinectedin
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Lurbinectedin

Other / unclassified

Developed for
small cell lung carcinoma · breast cancer · cancer · ovarian cancer · Ewing sarcoma · non-small cell lung carcinoma · soft tissue sarcoma · desmoplastic small round cell tumor
+28 more · endometrial cancer · leiomyosarcoma · neoplasm · urothelial carcinoma · acute leukemia · bladder small cell carcinoma · cancer of unknown primary site · childhood malignant neoplasm · colorectal cancer · colorectal carcinoma · digestive system cancer · digestive system neuroendocrine neoplasm · endometrial carcinoma · endometrium adenocarcinoma · gastric carcinoma · glioblastoma · head and neck carcinoma · malignant epithelial tumor of ovary · malignant pancreatic neoplasm · malignant pleural mesothelioma · mesothelioma · metastatic malignant neoplasm · metastatic neoplasm · neuroendocrine carcinoma · neuroendocrine neoplasm · pancreatic adenocarcinoma · pancreatic neuroendocrine tumor · sarcoma
Investigated by
PharmaMar · Jazz Pharmaceuticals · National Cancer Institute (NCI) · Jazz Pharmaceuticals Ireland Limited · AstraZeneca · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
+37 more · Luye Pharma Group Ltd. · M.D. Anderson Cancer Center · Massachusetts General Hospital · AdventHealth · Antonio Calles Blanco · Bristol-Myers Squibb · Children's Hospital of Philadelphia · Dana-Farber Cancer Institute · ERLINDA M GORDON · Emory University · Fox Chase Cancer Center · Fundacion Oncosur · G1 Therapeutics, Inc. · Gangnam Severance Hospital · Gilead Sciences · Guangzhou Institute of Respiratory Disease · H. Lee Moffitt Cancer Center and Research Institute · Hoffmann-La Roche · HonorHealth Research Institute · Institut Bergonié · Italian Sarcoma Group · Mayo Clinic · MedSIR · Merck Sharp & Dohme LLC · Misty Shields · National Cancer Center, Korea · Poveda, Andrés, M.D. · Samsung Medical Center · Seoul National Hospital · Seoul National University Bundang Hospital · Sichuan University · Stand Up To Cancer · Swiss Cancer Institute · UNC Lineberger Comprehensive Cancer Center · University of California, San Francisco · Vall d'Hebron Institute of Oncology · Yonsei University

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed small cell lung carcinoma 7 milestones
Filed Japan (PMDA) Zepzelca small cell lung carcinoma 2026-06-23

“Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca® (lurbinectedin)” pharmamar.com ↗

Filed EU (EMA) Zepzelca small cell lung carcinoma 2025-10-03

“PharmaMar has also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), which is currently under review.” pharmamar.com ↗

Filed EU (EMA) Zepzelca small cell lung carcinoma 2025-05-21

“has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Zepzelca® (lurbinectedin)” pharmamar.com ↗

Filed China (NMPA) — small cell lung carcinoma 2023-06-07

“New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE)” pharmamar.com ↗

Filed UK (MHRA) Zepzelca small cell lung carcinoma 2022-05-04

“submitted a conditional marketing authorization application to the UK’s MHRA for the treatment with lurbinectedin in adult patients with metastatic Small Cell Lung Cancer” pharmamar.com ↗

“has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).” pharmamar.com ↗

Filed Other Zepzelca small cell lung carcinoma 2022-03-08

“In December 2020, the company initiated a New Drug Submission for Zepzelca in SCLC with Health Canada's Therapeutic Products Directorate” jazzpharma.com ↗

“绿 叶 制 药 已 在 中 国 香 港 提 交Lurbinectedin的 新 药 上 市 申 请.” luye.com ↗

“Lurbinectedin已 在 中 国 香 港 地 区 提 交 新 药 上 市 申 请” luye.com ↗

Filed US (FDA) Zepzelca small cell lung carcinoma —

“In December 2019 , PharmaMar submitted an NDA to FDA for accelerated approval of lurbinectedin for relapsed SCLC” jazzpharma.com ↗

“we have submitted a supplemental New Drug Application for Zepzelca” jazzpharma.com ↗

Approved Indication not stated 3 milestones
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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 1/214 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 Stop: Business
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 2028 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 Stop: Enrollment
Phase 1/2 NCT04802174 Jun 2021 → Dec 2025 overdue small cell lung carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 221 trials · 2 met primary
Phase 2 NCT07459634 Nov 2026 → Jan 2028 expected small cell lung carcinoma Jazz Pharmaceuticals Recruiting No outcome recorded
Phase 2 NCT07640932 Nov 2026 → Apr 2027 expected small cell lung carcinoma Yonsei University Not yet recruiting No outcome recorded
Phase 2 NCT07258147 Oct 2026 → Dec 2027 expected small cell lung carcinoma Sichuan 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 Stop: Enrollment
Phase 2 NCT05574504 May 2023 → Nov 2026 metastatic malignant neoplasm, urothelial carcinoma AdventHealth Withdrawn No outcome recorded Stop: Enrollment
Phase 37 trials · 1 met primary · 3 missed
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 Missed primary
Phase 3 NCT05091567 Nov 2021 → Jul 2024 overdue small cell lung carcinoma Hoffmann-La Roche Active not recruiting Met primary
Phase 3 NCT02566993 Aug 2016 → Feb 2020 small cell lung carcinoma PharmaMar Completed Missed primary
Phase 3 NCT02421588 May 2015 → Oct 2018 ovarian cancer PharmaMar Completed Missed primary
Phase not stated1 trial
— NCT04291937 — small cell lung carcinoma Jazz Pharmaceuticals Approved for marketing No outcome recorded
Comparator or background therapy10 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 1/2 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 2 NCT07155174 Background Nov 2025 → Apr 2029 expected small cell lung carcinoma AbbVie Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 83

DateIssuerRelease
2026-10-01 Immedica Pharma AB Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved by the MHRA as first-line maintenance therapy for extensive-stage small cell lung cancer in the United Kingdom immedica.com ↗
Zepzelca was submitted and approved with the European Medicines Agency (EMA) acting as the Reference Regulator.
2026-09-24 PharmaMar Regulatory The United Kingdom approves Zepzelca® (lurbinectedin) by PharmaMar in combination with atezolizumab for first-line maintenance treatment of small cell lung cancer pharmamar.com ↗
2026-09-04 Immedica Pharma AB Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in Kuwait immedica.com ↗
Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) has been approved as a maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide in Kuwait.
2026-08-03 Immedica Pharma AB Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in Qatar immedica.com ↗
2026-08-03 PharmaMar Regulatory Canada, Qatar and South Korea Approve PharmaMar’s Zepzelca® in combination with Atezolizumab for First-Line Maintenance Treatment of Small Cell Lung Cancer pharmamar.com ↗
With these latest authorizations, the lurbinectedin–atezolizumab combination is now approved in 18 territories worldwide, including the European Union and the United States.
2026-06-23 PharmaMar Regulatory PharmaMar’s partner, Merck, has submitted a New Drug Application in Japan for Zepzelca® (lurbinectedin) regarding first line maintenance therapy in small cell lung cancer pharmamar.com ↗
PharmaMar (MSE: PHM), has announced that Merck (MRK.DE) has submitted a marketing application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for Zepzelca® (lurbinectedin) regarding the first line maintenance treatment of small cell lung cancer (SCLC).
2026-06-12 PharmaMar Results PharmaMar Reports Update on Phase III LAGOON Trial in Second Line for Small Cell Lung Cancer pharmamar.com ↗
Safety for lurbinectedin monotherapy is better compared to the control group.
2026-06-12 Jazz Pharmaceuticals Results Jazz Pharmaceuticals Provides Update on Zepzelca® (lurbinectedin) Phase 3 LAGOON Trial in Second-Line Small Cell Lung Cancer jazzpharma.com ↗
The trial did not meet its primary endpoint of overall survival (OS) evaluating Zepzelca as monotherapy or in combination with irinotecan compared to investigators' choice of topotecan or irinotecan.
2026-06-01 Immedica Pharma AB Regulatory Zepzelca® (lurbinectedin) in combination with atezolizumab approved by the European Commission as first-line maintenance therapy for extensive-stage small cell lung cancer immedica.com ↗
2026-06-01 PharmaMar Regulatory The European Commission approves PharmaMar’s Zepzelca® (lurbinectedin) for the treatment of extensive-stage small cell lung cancer in combination with atezolizumab pharmamar.com ↗
2026-04-20 PharmaMar Regulatory PharmaMar’s Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) has obtained another three approvals as first-line maintenance therapy for small cell lung cancer pharmamar.com ↗
2026-04-08 Lotus Pharmaceutical Regulatory Lotus Pharmaceutical Announces TFDA Approval of Zepzelca® (lurbinectedin) in Combination with Immunotherapy as First-Line Maintenance Therapy for ES-SCLC lotuspharm.com ↗
Zepzelca® (lurbinectedin), its licensed oncology product, has received approval from the Taiwan Food and Drug Administration (TFDA) for use in combination with atezolizumab as a first-line maintenance treatment for adult patients with extensive-stage small-cell lung cancer (ES-SCLC).

All press releases naming this drug 108 releases

DateIssuerRelease
Show all 108 releases opens the full record — a long page

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 68 sources stand behind the page.

FieldValueCited 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 2018
60

“PURPOSE: Lurbinectedin (PM01183) binds covalently to DNA and has broad activity against tumor cell lines.” PMID 24563480 ↗ Feb 2014

“Lurbinectedin (PM01183)” NCT01831089 ↗

NCT05229588 ↗

NCT04358237 ↗

NCT04607954 ↗

NCT01970553 ↗

NCT06801834 ↗

NCT05636111 ↗

NCT07121478 ↗

NCT04291937 ↗

Show 50 more sources

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 2018
18

“lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01970540 ↗

“lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.” NCT01980667 ↗

“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)” NCT01970553 ↗

Show 8 more sources

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 ↗