Data updated: May 26, 2026
EVDI (trabectedin)
Approved 2026-05-01
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-05-01
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
EVDI Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What EVDI Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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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 | not yet 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 | active not 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 | 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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
EVDI FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.