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Drug

Trabectedin

Approved · EMA
Emerging researchLate-stage development

Also known as Yondelis, Trabectedina.

RxNorm1716278ChEMBLCHEMBL450449UNIIID0YZQ2TCP
3
Research papers
10
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase III Study Comparing Trabectedin (T) Versus T Plus tTF-NGR to Entrap T Inside the Tumor in Patients With Metastatic and/or Refractory Soft Tissue Sarcoma (STS)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients With Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy

Clinical trial2026-06-01Results posted · ClinicalTrials.gov

Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Clinical trial2026-03-27Results expected Q4 2026 · ClinicalTrials.gov

A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy

Clinical trial2026-03-25Results expected Q4 2026 · ClinicalTrials.gov

A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas

Clinical trial2026-03-03Results expected Q4 2031 · ClinicalTrials.gov

Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Clinical trial2025-08-29Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Clinical trial2025-07-29Results expected Q4 2027 · ClinicalTrials.gov

Approval: Trabectedin Accord (EMA)

Regulatory2025-04-25EMA

A phase 2 trial of trabectedin in children with recurrent rhabdomyosarcoma, Ewing sarcoma and non-rhabdomyosarcoma soft tissue sarcomas: a report from the Children's Oncology Group.

Research2011-11-14European journal of cancer (Oxford, England : 1990)

A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study.

Research2011-10-13Gynecologic oncology

Approval: Yondelis (EMA)

Regulatory2007-09-17EMA

Effect of ecteinascidin-743 on the interaction between DNA binding proteins and DNA.

Research1999-06-01Anti-cancer drug design

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Trabectedin
Aliases & brands
YondelisTrabectedina
RxNorm CUI
1716278
ChEMBL ID
CHEMBL450449
UNII
ID0YZQ2TCP
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-09-17
Latest approval
2025-04-25
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2025-04-25Approval
Approval: Trabectedin Accord (EMA)
Indication: 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… Show full indication

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.

Evidence ↗
2007-09-17Approval
Approval: Yondelis (EMA)
Indication: Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.… Show full indication

Yondelis is indicated for the treatment of 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. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

67 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
67
registered trials across all phases
LATEST COMPLETION 2025
10
Active studies
8
Recruiting
17
Late-stage (III+)
43
Completed
14
Discontinued
PHASE DISTRIBUTIONn = 67
Phase 17Phase 1 / 25Phase 238Phase 2 / 32Phase 314Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Active, not recruitingPH IIIIntensity Therapeutics, Inc.n=3332028

A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients With Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy

Active, not recruitingPH II/IIINational Cancer Institute (NCI)n=742027

Phase III Study Comparing Trabectedin (T) Versus T Plus tTF-NGR to Entrap T Inside the Tumor in Patients With Metastatic and/or Refractory Soft Tissue Sarcoma (STS)

RecruitingPH IIIUniversität Münstern=1262026

A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma

TerminatedPH IIIRain Oncology Incn=1752023

Randomised Phase III Multicentric Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin in Non-progressive Patients Versus Doxorubicine Alone as First-line Therapy in Patients With Metastatic or Unresectable Leiomyosarcoma (Uterine or Soft Tissue)

CompletedPH IIIGustave Roussy, Cancer Campus, Grand Parisn=1502021

Recent completions

Trials that read out recently, adding to the completed evidence base.

SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin Administered as a 1-Hour Infusion in Ewing Sarcoma Patients in Combination With Low Dose Irinotecan and 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging

CompletedPH I/IISarcoma Alliance for Research through Collaborationn=372025

Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients

CompletedPH IIItalian Sarcoma Groupn=232024

Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

CompletedPH IIUniversity of Michigan Rogel Cancer Centern=292024

A Phase II Study on Trabectedin in Combination With PPARg Agonist Pioglitazone in Patients With Round Cell Myxoid Liposarcomas or Dedifferentiated G1 and G2 Liposarcomas With Stable Disease After a Monotherapy With Trabectedin. (TRABEPIO)

CompletedPH IIMario Negri Institute for Pharmacological Researchn=102024

Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

CompletedN/AInstitut Bergonién=292024

A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies

CompletedPH IINational Center for Tumor Diseases, Heidelbergn=1022023

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992012
Journals, researchers & institutions
Top journals
  • Anti-cancer drug design1
  • European journal of cancer (Oxford, England : 1990)1
  • Gynecologic oncology1
Leading researchers
  • Adamson PC1
  • Baker KS1
  • Baruchel S1
  • Blaney SM1
  • Blessing JA1
  • Bonfanti M1
  • Burke JJ1
  • Caretti G1
Leading institutions
free-text, unnormalised
  • Creighton University School of Medicine at St. Joseph's Hospital and Medical Center1
  • The Hospital for Sick Children1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.