Yondelis

(Trabectedin)

ApprovedSmall molecule

Trabectedin is used to treat certain types of cancer, particularly soft tissue sarcoma and ovarian cancer. It works by damaging cancer cell DNA to stop the cancer from growing.[2] Yondelis is currently approved and in use across 26 indications[4].[1]

Yondelis is one of 470 small molecule programs targeting Uterine Leiomyosarcoma. It is currently in Approved.

Indications

Total Trials

Active Trials

469

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Uterine LeiomyosarcomaRecruiting

Soft Tissue NeoplasmApproved

LeiomyosarcomaActive, not recruiting

Malignant Pleural MesotheliomaActive, not recruiting

OsteosarcomaActive, not recruiting

Dedifferentiated LiposarcomaActive, not recruiting

MesotheliomaApproved

Mesenchymal ChondrosarcomaActive, not recruiting

CarcinosarcomaActive, not recruiting

Malignant MesotheliomaActive, not recruiting

Uterine LeiomyosarcomaPhase 2

Recruiting

Soft Tissue NeoplasmApproved

Approved

LeiomyosarcomaPhase 3

Active, not recruiting

Malignant Pleural MesotheliomaPhase 2

Active, not recruiting

OsteosarcomaPhase 2

Active, not recruiting

Dedifferentiated LiposarcomaPhase 3

Active, not recruiting

MesotheliomaApproved

Approved

Mesenchymal ChondrosarcomaPhase 2

Active, not recruiting

CarcinosarcomaPhase 2

Active, not recruiting

Malignant MesotheliomaPhase 2

Active, not recruiting

Showing 10 of 26 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Yondelis

AApotex Inc.

Approved

1 2

Tykerb

GSK

Preclinical

80 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Prolia

Amgen

Preclinical

14 6

Gemzar

GGynecologic Oncology Group

Preclinical

22 7

Lexiscan

Astellas

Preclinical

1 8

Zinecard

CChildren's Oncology Group

Preclinical

2 9

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 10

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Randomized

NCT05597917

Phase 2Recruiting

Leiomyosarcoma

NCT04383119

Phase 2Recruiting

Mesenchymal Chondrosarcoma

NCT04305548

Q1 2027

Phase 2/3Active, not recruiting

Uterine Leiomyosarcoma

NCT05432791

Q2 2028

Phase 1/2Recruiting

Soft Tissue Sarcoma

NCT02275286

Q4 2028

Phase 3Active, not recruiting

Soft Tissue Sarcoma

NCT06263231

Clinical

Trials by Indication[1]

Soft Tissue Sarcoma17 trials

Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00017030

Retrospective Study of Trabectedin in Soft Tissue Sarcomas

Completed·IItalian Sarcoma Group··NCT02793050·510 enrolled

Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

Completed·UUniversity Medicine Greifswald·Phase 2·NCT03590210·92 enrolled

Show 14 more trials

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07444619·18 enrolled

Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003939·132 enrolled

Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

Completed·IItalian Sarcoma Group·Phase 3·NCT01710176·550 enrolled

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

Recruiting·SSarcoma Oncology Research Center, LLC·Phase 1/2·NCT03138161·250 enrolled

A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

No longer available· Johnson & Johnson logo

Johnson & Johnson··NCT00210665

Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

Recruiting·GGrupo Espanol de Investigacion en Sarcomas·Phase 1/2·NCT02275286·199 enrolled

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

Active, not recruiting·IIntensity Therapeutics, Inc.·Phase 3·NCT06263231·333 enrolled

Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma

Completed·CCentre Oscar Lambret·Phase 2·NCT01303094·53 enrolled

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

Completed·IInstitut Bergonié·N/A·NCT04008238·29 enrolled

Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT01189253·133 enrolled

A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00102609·41 enrolled

Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

Completed·PPharmaMar, Spain··NCT02367924·130 enrolled

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

Completed·CChildren's Oncology Group·Phase 2·NCT00070109·50 enrolled

Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma

Recruiting·SSarcoma Oncology Research Center, LLC·Phase 2·NCT04535271·80 enrolled

Leiomyosarcoma8 trials

Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma

Withdrawn·UUniversity of Miami·Phase 1·NCT03437070

Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

Recruiting·IItalian Sarcoma Group·Phase 2·NCT04383119·100 enrolled

Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT03074318·35 enrolled

Show 5 more trials

Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT02131480·110 enrolled

Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin Versus Doxorubicine in Patients With Leiomyosarcoma

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT02997358·150 enrolled

Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Completed·GGynecologic Oncology Group·Phase 2·NCT00379145·20 enrolled

A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01343277·579 enrolled

A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01692678·16 enrolled

Ovarian Cancer6 trials

Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer

Unknown status·—·Phase 2·NCT01772979·100 enrolled

Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

Terminated·AAGO Research GmbH·Phase 3·NCT03690739·9 enrolled

Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients

Completed·PPharmaMar··NCT02825420·220 enrolled

Show 3 more trials

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00113607·672 enrolled

INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 3·NCT01379989·617 enrolled

A Study of Trabectedin in Patients With Advanced Ovarian Cancer

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00050414·147 enrolled

Uterine Leiomyosarcoma4 trials

Activity of Trabectedin or Gemcitabine + Docetaxel in Uterine Leiomyosarcoma

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT02249702·168 enrolled

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2/3·NCT05432791·73 enrolled

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

Recruiting·UUNICANCER·Phase 2·NCT06524583·198 enrolled

Show 1 more trial

Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma

Suspended·MM.D. Anderson Cancer Center·Phase 2·NCT07076186·48 enrolled

Fallopian Tube Cancer3 trials

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

Completed·GGynecologic Oncology Group·Phase 2·NCT00569673·71 enrolled

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

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 3·NCT02903004·242 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01846611·581 enrolled

34 more indications

Dedifferentiated Liposarcoma2 trials

Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

Completed·IItalian Sarcoma Group·Phase 2·NCT02247544·105 enrolled

Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma

Terminated·RRain Oncology Inc·Phase 3·NCT04979442·175 enrolled

Metastatic Sarcoma2 trials

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT04076579·29 enrolled

Multicohort Trial of Trabectedin and Low-dose Radiation Therapy in Advanced/Metastatic Sarcomas

Unknown status·GGrupo Espanol de Investigacion en Sarcomas·Phase 2·NCT05131386·85 enrolled

Advanced Malignancies2 trials

A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT01267084·12 enrolled

A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01273493·15 enrolled

Resectable Sarcoma1 trial

Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma

Withdrawn·FFred Hutchinson Cancer Center·Phase 2·NCT03397186

Randomized1 trial

tTF-NGR Randomized Study - STS

Recruiting·UUniversität Münster·Phase 3·NCT05597917·126 enrolled

Efficacy and Safety1 trial

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00796120·121 enrolled

Pancreatic Cancer1 trial

Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy

Completed·IIRCCS San Raffaele·Phase 2·NCT01339754·25 enrolled

Solitary Fibrous Tumor1 trial

Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor

Completed·IItalian Sarcoma Group·Phase 2·NCT03023124·23 enrolled

Advanced Sarcoma1 trial

Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)

Completed·IItalian Sarcoma Group·Phase 1·NCT02398058·50 enrolled

Liposarcoma1 trial

Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00579501·29 enrolled

Endometrial Carcinoma1 trial

Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00050440·50 enrolled

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00072670·59 enrolled

Myxoid Liposarcoma1 trial

Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone.

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT04794127·10 enrolled

Solid Tumors1 trial

Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

Completed·NNational Center for Tumor Diseases, Heidelberg·Phase 2·NCT03127215·102 enrolled

Synovial Sarcoma1 trial

Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin

Withdrawn·IItalian Sarcoma Group·Phase 3·NCT03773510

Osteosarcoma1 trial

Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00005625

Efficacy1 trial

Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin

Unknown status·LLudwig-Maximilians - University of Munich·Phase 2·NCT02359474·120 enrolled

Mesenchymal Chondrosarcoma1 trial

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Recruiting·IItalian Sarcoma Group·Phase 2·NCT04305548·16 enrolled

Malignant Pleural Mesothelioma1 trial

ATREUS - Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT02194231·145 enrolled

Breast Cancer1 trial

An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00580112·127 enrolled

Carcinosarcoma1 trial

Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 2·NCT02993705·45 enrolled

First Line Therapy1 trial

Trabectedin First Line Therapy In Unfit Sarcoma Study

Completed·IItalian Sarcoma Group·Phase 2·NCT02066675·24 enrolled

Ewing sarcoma1 trial

SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

Completed·SSarcoma Alliance for Research through Collaboration·Phase 1/2·NCT04067115·37 enrolled

Adolescent1 trial

Tabectedin to Treat Children and Adolescents With Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01453283·12 enrolled

CAR1 trial

A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00786838·76 enrolled

AIN1 trial

Trabectedin Maintenance Post 1st-line in STS

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT02929394·13 enrolled

Doxorubicin1 trial

Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

Terminated·GGrupo Espanol de Investigacion en Sarcomas·Phase 2·NCT01104298·115 enrolled

Sarcoma1 trial

Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT02672527·103 enrolled

Malignant Mesothelioma1 trial

Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

Terminated·PPharmaMar·Phase 2·NCT00027508

Chronic Lymphocytic Leukemia1 trial

Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT03884972

ISS1 trial

Pharmacometabolomic of Trabectedin in Soft Tissue Patients

Completed·CCentro di Riferimento Oncologico - Aviano··NCT04394728·44 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 23, 2015

YONDELIS

NDA NDA207953

May 1, 2026

EVDI

NDA NDA220837

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for Trabectedin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Yondelis drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Trabectedin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Trabectedin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA220837). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Yondelis. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Apotex Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AApotex Inc.

Patent Landscape[6]

Patent Cliff

Jan 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8895557Jan 7, 2028

8895557*PEDJul 7, 2028

12303506Feb 18, 2043

Yondelis

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2028

Q4 2028

Trials by Indication[1]

Soft Tissue Sarcoma17 trials

Leiomyosarcoma8 trials

Ovarian Cancer6 trials

Uterine Leiomyosarcoma4 trials

Fallopian Tube Cancer3 trials

Dedifferentiated Liposarcoma2 trials

Metastatic Sarcoma2 trials

Advanced Malignancies2 trials

Resectable Sarcoma1 trial

Randomized1 trial

Efficacy and Safety1 trial

Pancreatic Cancer1 trial

Solitary Fibrous Tumor1 trial

Advanced Sarcoma1 trial

Liposarcoma1 trial

Endometrial Carcinoma1 trial

ESS1 trial

Advanced Solid Tumors1 trial

Meningioma1 trial

Prostate Cancer1 trial

Myxoid Liposarcoma1 trial

Solid Tumors1 trial

Synovial Sarcoma1 trial

Osteosarcoma1 trial

Efficacy1 trial

Mesenchymal Chondrosarcoma1 trial

Malignant Pleural Mesothelioma1 trial

Breast Cancer1 trial

Carcinosarcoma1 trial

First Line Therapy1 trial

Ewing sarcoma1 trial

Adolescent1 trial

CAR1 trial

AIN1 trial

Doxorubicin1 trial

Sarcoma1 trial

Malignant Mesothelioma1 trial

Chronic Lymphocytic Leukemia1 trial

ISS1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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