Lurbinectedin clinical trials
Lurbinectedin is named as an intervention in 17 current clinical trials in our USA, China, Spain, Germany, Italy, Belgium, South Korea, Poland, France, Japan, Taiwan, UK, Netherlands, Switzerland, Austria, Turkey, Canada, Brazil, Portugal, Mexico, Australia, Israel, Czechia, Ireland, Denmark, Singapore, Norway and Egypt registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Jazz Pharmaceuticals (2). The most-studied condition is Small Cell Lung Cancer.
Where Lurbinectedin is approved
All regulators →Of the three regulators tracked here, the first to approve Lurbinectedin was the US, on 15 Jun 2020. It is approved in 3 of the 3 regulators tracked here.
- 4 EU orphan designations, most recently for treatment of soft tissue sarcoma (21 Apr 2023, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Lurbinectedin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lurbinectedin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 4 listed patents; the last listed expires 29 May 2040 (US 12324806).
- Latest patent on the drug substance itself: 13 Dec 2029 (US 7763615).
- Exclusivity I-977: New indication: lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for maintenance treatment of adult p…, until 2 Oct 2028.
- Exclusivity ODE-304: Orphan drug exclusivity: indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progressi…, until 15 Jun 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lurbinectedin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Lurbinectedin works
All drug targets →- CancerPhase 3
- Childhood leukemiaPhase 3
- LeiomyosarcomaPhase 3
- Lung cancerPhase 3
- Ovarian cancerPhase 3
- Ewing sarcomaPhase 2
- Ewing sarcoma/peripheral primitive neuroectodermal tumorPhase 2
- Breast cancerPhase 2
- Breast carcinomaPhase 2
- Desmoplastic small round cell tumorPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297516, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10681, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Lurbinectedin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ZepzelcaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Lurbinectedin
17 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Lurbinectedin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Lurbinectedin on the HPRA medicines list.
- ZEPZELCA 2 mg powder for concentrate for solution for infusionPharma Mar S.A. · EU/1/26/2032/001
- ZEPZELCA 4 mg powder for concentrate for solution for infusionPharma Mar S.A. · EU/1/26/2032/002
Supply shortages
No entry for Lurbinectedin in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- ZepzelcaEMA · 29 May 2026 · Pharma Mar S.A.
Conditions studied with Lurbinectedin
20 conditionsAll 20 conditions
| Condition (as registered) | Trials |
|---|---|
| Small Cell Lung Cancer | 3 |
| Small Cell Lung Cancer (SCLC) | 2 |
| Small-Cell Lung Cancer | 1 |
| Extensive Stage Small Cell Lung Cancer (ES-SCLC) | 1 |
| Leiomyosarcoma | 1 |
| Refractory Ewing Sarcoma | 1 |
| Relapsed Ewing Sarcoma | 1 |
| Ewing Sarcoma | 1 |
| Extensive-stage Small-cell Lung Cancer | 1 |
| Large Cell Neuroendocrine Cancer (LCNEC) | 1 |
| Neuroendocrine Prostate Cancer (NEPC) | 1 |
| Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC) | 1 |
| Extensive-Stage Small Cell Lung Cancer | 1 |
| Small Cell Lung Carcinoma | 1 |
| Relapsed Small Cell Lung Cancer | 1 |
| Lung Cancer (SCLC) | 1 |
| Desmoplastic Small Round Cell Tumor | 1 |
| Neuroendocrine Tumor of Pancreas | 1 |
| Pancreatic Neuroendocrine Tumors | 1 |
| Carcinoma, Small Cell Lung | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Lurbinectedin trials
How many clinical trials are testing Lurbinectedin?
17 current trials in our USA, China, Spain, Germany, Italy, Belgium, South Korea, Poland, France, Japan, Taiwan, UK, Netherlands, Switzerland, Austria, Turkey, Canada, Brazil, Portugal, Mexico, Australia, Israel, Czechia, Ireland, Denmark, Singapore, Norway and Egypt registers name Lurbinectedin (also registered as PM01183/JZP712) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Lurbinectedin trials recruiting patients?
Yes. 10 of the 17 trials are recruiting: 7 with sites in USA, 5 with sites in China, 5 with sites in Spain, 4 with sites in Germany, 4 with sites in Italy, 4 with sites in Belgium, 3 with sites in South Korea, 3 with sites in Poland, 3 with sites in France, 4 with sites in Japan, 3 with sites in Taiwan, 1 with sites in UK, 2 with sites in Netherlands, 2 with sites in Switzerland, 2 with sites in Austria, 2 with sites in Turkey, 3 with sites in Canada, 3 with sites in Brazil, 1 with sites in Portugal, 1 with sites in Mexico, 2 with sites in Australia, 2 with sites in Israel, 1 with sites in Czechia, 1 with sites in Norway and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lurbinectedin clinical trials?
Jazz Pharmaceuticals (2), AbbVie (2), Amgen (1) and Hoffmann-La Roche (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Lurbinectedin clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Lurbinectedin licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Lurbinectedin, for example ZEPZELCA 2 mg powder for concentrate for solution for infusion (Pharma Mar S.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Lurbinectedin shortage?
Not in the lists we track: Lurbinectedin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lurbinectedin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Lurbinectedin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Lurbinectedin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.