Data updated: May 26, 2026
YONDELIS (trabectedin)
Alkylating Activity
Trial Activity: Stable 11 active trials
Oncology
Approved 2015-10-23
Yondelis treats adults with liposarcoma or leiomyosarcoma that has spread to other parts of the body or cannot be removed by surgery. It is used for patients who have already received a prior chemotherapy regimen containing an anthracycline. This medication helps patients with these specific soft tissue cancers by interfering with the cellular processes necessary for tumor growth.
How YONDELIS Works
This alkylating drug works by binding to guanine residues in the minor groove of DNA, which causes the DNA helix to bend. This formation of adducts disrupts DNA repair pathways and the activity of certain transcription factors. These disruptions interfere with the cell cycle, which eventually leads to cell death.
Development Insights
Italian Sarcoma Group conducting 6 trials (12%)
67 indications explored (Broad Platform)
→ soft tissue sarcoma (5 trials)
→ leiomyosarcoma (5 trials)
→ sarcoma (4 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-10-23
- Patent Cliff
- 2028
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
YONDELIS Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2015 to 2025 · 1 indication expansions
What YONDELIS Treats
2 indicationsYONDELIS is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Liposarcoma
- Leiomyosarcoma
Source: FDA Label
YONDELIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
2
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in YONDELIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications YONDELIS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to YONDELIS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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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 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.
YONDELIS FDA Label Details
Indications & Usage
FDA Label (PDF)YONDELIS is indicated for the treatment of Liposarcoma; Leiomyosarcoma.
View full patent landscape →
2 OB patents · 1 families ·
55 international docs across 37 countries
YONDELIS Patents & Exclusivity
Latest Patent: Jul 2028
Patents (2 active)
US8895557*PED
Expires Jul 7, 2028
US8895557
Expires Jan 7, 2028
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for YONDELIS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 2 active patents
Trial Analysis
- • 49 total trials
- • Stage: Stable
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment