Drug · Small Molecule
Trabectedin
CI-DRUG-00000601Explore in graph →NCIt C1691 CHEMBL450449 CIViC Approved
Regulatory
Approvals (7)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | — | Trabectedin Accord is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Trabectedin Accord in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer. | approved | Apr 25, 2025 | ema |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 9 | 9 | 15 | 68 | 7 | CA, EU, US | Sep 17, 2007 | 1996-02 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 1 | 1 | 3 | 7 | 0 | — | — | 2005-04 |
| Malignant Uterine Corpus Neoplasm | Phase2 | Phase 2 | 1 | 1 | 0 | 3 | 0 | — | — | 2011-02 |
| Malignant Mesothelioma | Phase2 | Phase 2 | 0 | 0 | 0 | 2 | 0 |
Curated evidence
Clinical evidence (6)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 38074516
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ATF1 Fusion1 | ||||||||
| Trabectedin | Clear Cell Sarcoma of Soft Tissue | |||||||
Clinical trials
Trials with this intervention (74)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00796120 | An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS) | completed | Phase 3 | 121 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C.INDUSTRY | 5 | Dec 10, 2015 | clinicaltrials |
| NCT01104298 | Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS |