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Compound · clinical trials

Trabectedin clinical trials

Also listed in trial records as Yondelis
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 6 trials in our France, Italy, Germany, Spain, USA and Canada registers that name Trabectedin as an intervention. Synced 27 Sep 2026
6Current trials
6Recruiting now
5Lead sponsors
6Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Trabectedin is named as an intervention in 6 current clinical trials in our France, Italy, Germany, Spain, USA and Canada registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Italian Sarcoma Group (2). The most-studied condition is Soft Tissue Sarcoma. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Trabectedin is approved

All regulators →

Trabectedin was first approved in the EU on 17 Sep 2007. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
23 Oct 2015
Yondelis
NDA207953 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
17 Sep 2007
Yondelis
EMA product page
First centralised authorisation
CACanada (Health Canada)
13 May 2010
Yondelis
Notice of Compliance 11372
First new-drug NOC

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.

Trials by status

  • Recruiting6100%

Trials by phase

  • Phase 2350%
  • Phase 3233%
  • Phase 1/2117%
01

Clinical trials of Trabectedin

6 trials
StudyPhaseStatusLead sponsorRegisters
tTF-NGR Randomized Study - STS
NCT05597917 · ClinicalTrials.gov ↗ · Soft Tissue Sarcoma
Phase 3 Recruiting Universitรคt Mรผnster Germany
A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
NCT06263231 · ClinicalTrials.gov ↗ · Sarcoma,Soft Tissue
Phase 3 Recruiting Intensity Therapeutics, Inc USA, Germany, France, Spain, Canada
Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
NCT04305548 · ClinicalTrials.gov ↗ · Mesenchymal Chondrosarcoma
Phase 2 Recruiting Italian Sarcoma Group Italy
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
NCT04383119 · ClinicalTrials.gov ↗ · Leiomyosarcoma of Ovary, Soft Tissue Sarcoma
Phase 2 Recruiting Italian Sarcoma Group Italy
Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
NCT06524583 · ClinicalTrials.gov ↗ · Leiomyosarcoma Uterus
Phase 2 Recruiting UNICANCER France
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
NCT02275286 · ClinicalTrials.gov ↗ · Liposarcoma, Myxoid, Sarcoma, Soft Tissue, Leiomyosarcoma
Phase 1/2 Recruiting Grupo Espanol de Investigacion en Sarcomas France, Spain, Italy

Registers 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.

02

Trabectedin in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Trabectedin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
Multicentre, randomized, open label study comparing the concomitant administration of trabectedin and low-dose radiotherapy versus trabectedin alone in patients with advanced sarcoma
2026-525703-27-00 · Musculoskeletal Diseases
Phase 4 Authorised Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz Spain
03

Trabectedin across our data

Ireland · EU · US

The 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)

6 single-substance products containing Trabectedin on the HPRA medicines list.

  • Trabectedin Accord 0.25 mg powder for concentrate for solution for infusionAccord Healthcare S.L.U. · EU/1/24/1902/001
  • Trabectedin Accord 1 mg powder for concentrate for solution for infusionAccord Healthcare S.L.U. · EU/1/24/1902/002
  • Trabectedin EVER Pharma 0.25 mg powder for concentrate for solution for infusionEVER Valinject GmbH · PA1774/013/001 · Not marketed
  • Trabectedin EVER Pharma 1 mg powder for concentrate for solution for infusionEVER Valinject GmbH · PA1774/013/002 · Not marketed
  • Yondelis 0.25 mg Powder for concentrate for solution for infusionPharma Mar S.A. · EU/1/07/417/1
All 6 Irish products →

Supply shortages

No entry for Trabectedin in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Trabectedin

9 conditions
Soft Tissue Sarcoma2Sarcoma,Soft Tissue1Leiomyosarcoma Uterus1Liposarcoma, Myxoid1Sarcoma, Soft Tissue1Leiomyosarcoma1Liposarcoma1Mesenchymal Chondrosarcoma1Leiomyosarcoma of Ovary1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Italian Sarcoma Group2
Intensity Therapeutics, Inc1
Universitรคt Mรผnster1
UNICANCER1
Grupo Espanol de Investigacion en Sarcomas1
06

By country register

RegisterTrialsRecruiting
Clinical trials in France33
Clinical trials in Italy33
Clinical trials in Germany22
Clinical trials in Spain22
Clinical trials in USA11
Clinical trials in Canada11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Trabectedin trials

How many clinical trials are testing Trabectedin?

6 current trials in our France, Italy, Germany, Spain, USA and Canada registers name Trabectedin as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Trabectedin trials recruiting patients?

Yes. 6 of the 6 trials are recruiting: 3 with sites in France, 3 with sites in Italy, 2 with sites in Germany, 2 with sites in Spain, 1 with sites in USA and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Trabectedin clinical trials?

Italian Sarcoma Group (2), Intensity Therapeutics, Inc (1), Universitรคt Mรผnster (1) and UNICANCER (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Trabectedin licensed in Ireland?

Yes. The HPRA medicines list includes 6 single-substance products containing Trabectedin, for example Trabectedin Accord 0.25 mg powder for concentrate for solution for infusion (Accord Healthcare S.L.U.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Trabectedin shortage?

Not in the lists we track: Trabectedin 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 Trabectedin works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Trabectedin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Trabectedin (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 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.