TheraRadar
Data updated: Nov 8, 2026

TRABECTEDIN · EVER

Generic · see EVDI
Oncology Approved 2015-10-23

TRABECTEDIN is FDA-approved to treat 2 conditions (same as YONDELIS).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2015-10-23
Routes
INTRAVENOUS, INJECTION
Dosage Forms
POWDER, INJECTABLE

Companies

EVER NATCO PHARMA LTD
Active Ingredient: TRABECTEDIN

TRABECTEDIN Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Oct 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What TRABECTEDIN Treats

2 indications

TRABECTEDIN is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Liposarcoma
  • Leiomyosarcoma

Same approved indications as YONDELIS (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

48 trials
Trial Sponsor ID Phase Status Title
NCT05432791 results posted NCI-2022-05065 NCI-2022-05065, A092104 Ph 2, Ph 3 active not recruiting Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
NCT04305548 ISG-MCS ISG-MCS Ph 2 recruiting Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
NCT04383119 ISG-ARTICLE ISG-ARTICLE Ph 2 recruiting Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
NCT01303094 T-DIS T-DIS-1001 2010-022613-26 Ph 2 completed Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma
NCT07076186 2025-0352 NCI-2025-05088 Ph 2 recruiting Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
NCT07444619 2025-1035 NCI-2026-01398 Ph 1 recruiting 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
NCT04794127 TRABEPIO IRFMN-SARCO-7953 Ph 2 completed Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.
NCT04076579 results posted UMCC 2018.132 HUM00161251 Ph 2 completed Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
NCT06263231 INVINCIBLE-3 IT-03 Ph 3 recruiting A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
NCT02234050 results posted EORTC-1320-BTG 2014-002446-47 Ph 2 completed Trabectedin for Recurrent Grade II/III Meningioma
NCT05597917 TRABTRAP WWU19_0007 2024-516392-33-00, 2020-005858-21 Ph 3 recruiting tTF-NGR Randomized Study - STS
NCT06524583 L-UteCIN UC-SAR-2212 2023-506350-21-00, 2023 Ph 2 recruiting 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
NCT04535271 TAGGED SOC-2101 Ph 2 recruiting Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma
NCT03138161 SOC-1702 Ph 1, Ph 2 recruiting SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
NCT04979442 MANTRA results posted RAIN-3201 Ph 3 terminated Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
NCT03023124 STRADA ISG STRADA Ph 2 completed Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor
NCT03127215 NCT-PMO-1603 NCT-2017-0417 Ph 2 completed Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors
NCT03884972 2018-0302 NCI-2019-01555, 2018-0302 Ph 1 withdrawn Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor
NCT02275286 TRASTS GEIS 37 Ph 1, Ph 2 recruiting Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
NCT03590210 NiTraSarc GISG-15 2017-001083-38 Ph 2 completed Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas
NCT03074318 results posted 9717 NCI-2017-00234, 9717 Ph 1, Ph 2 terminated Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery
NCT03690739 AGO-OVAR 2.32 Ph 3 terminated Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer
NCT01379989 INOVATYON ET-D-009-10 Ph 3 completed INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
NCT02997358 LMS04 2016-002186-56 2016/2410 Ph 3 completed Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma
NCT02247544 TRAVELL ISG-STS-TRAB-2012 2012-005428-14 Ph 2 completed Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma
NCT02903004 MITO23 986 Ph 3 completed Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients
NCT02993705 MITO 26 1561 Ph 2 completed Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)
NCT02398058 TOMAS TOMAS 2013-003638-33 Ph 1 completed Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)
NCT02929394 EORTC-1447-STBSG 2016-003535-38 Ph 3 terminated Trabectedin Maintenance Post 1st-line in STS
NCT02194231 ATREUS IRFMN-MPM-6077 2011-006330-16 Ph 2 completed ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
NCT03397186 9769 NCI-2017-02298, 9769 Ph 2 withdrawn Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma
NCT01846611 results posted CR100983 ET743OVC3006, 2012-004808-34 Ph 3 completed A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT03437070 20170991 Ph 1 withdrawn Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
NCT00070109 results posted ADVL0221 NCI-2009-00357, CDR0000329999 Ph 2 completed Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
NCT02672527 TSAR 2014-003176-23 2014/2154 Ph 3 completed Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma
NCT00569673 results posted GOG-0186F GOG-0186F, CDR0000577866 Ph 2 completed Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
NCT01692678 CR017269 ET743SAR3006 Ph 3 completed A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
NCT02066675 TR1US ISG TR1US 2013-001467-23 Ph 2 completed Trabectedin First Line Therapy In Unfit Sarcoma Study
NCT02249702 TAUL TAUL 2009-016017-24 Ph 2 completed Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma
NCT02131480 LMS02 2009-012430-70 2008/1485 Ph 2 completed Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
NCT01343277 results posted CR018004 ET743SAR3007 Ph 3 completed A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
NCT01273493 CR017542 ET7430OVC1004 Ph 1 completed A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
NCT00796120 results posted CR015769 ET-C-002-07 Ph 3 completed An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
NCT01104298 GEIS-20 2008-008922-55 Ph 2 terminated Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS
NCT01267084 CR017539 ET743OVC1003 Ph 1, Ph 2 completed A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies
NCT01339754 PACT-18 CDR0000698981 PACT-18, 2010-024287-17 Ph 2 completed Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
NCT01189253 EORTC-62091 EORTC-62091, 2009-014889-26 Ph 2, Ph 3 terminated Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
NCT00786838 results posted CR014917 ET743OVC1001 Ph 2 completed A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TRABECTEDIN FDA Label Details

Indications & Usage

FDA Label (PDF)

TRABECTEDIN is FDA-approved to treat 2 conditions — same approved indications as YONDELIS.

Looking for the branded version?

EVDI

Full clinical data, patents, trials, and competitive landscape for trabectedin.

See EVDI

Data Sources

FDA Approval: NDA219617 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.