Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | YONDELIS | — | 2018-06-29 | fda.gov ↗ |
| Approved | US (FDA) | YONDELIS | — | 2015-10-23 | fda.gov ↗ |
| Approved | EU (EMA) | Yondelis | — | 2007-09-17 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Yondelis | — | 2004-09-07 | europa.eu ↗ |
Trials 78 · started per year
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07444619 Background | Jun 2026 → Dec 2031 expected | soft tissue sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06333314 Comparator | Jul 2024 → Oct 2028 expected | adrenal cortex carcinoma, carcinoma of the ampulla of vater, duodenal adenocarcinoma, gastric adenocarcinoma +3 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT03838744 Comparator | May 2020 → Nov 2024 | soft tissue sarcoma | Italian Sarcoma Group | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05432791 Comparator | Mar 2023 → Aug 2024 overdue | leiomyosarcoma of the corpus uteri | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06263231 Comparator | Jun 2024 → Dec 2027 expected | soft tissue sarcoma | Intensity Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04979442 Comparator | Jul 2021 → Oct 2023 | dedifferentiated liposarcoma | Rain Oncology Inc | Terminated | No outcome recorded |
| Phase 3 | NCT03690739 Comparator | Aug 2019 → Mar 2021 | ovarian carcinoma | AGO Research GmbH | Terminated | No outcome recorded |
| Phase 3 | NCT02929394 Comparator | Nov 2017 → Jun 2020 | soft tissue sarcoma | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 93 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trabectedin | “Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients” NCT00050427 ↗83“Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer.” NCT00060944 ↗ “Doxorubicin and ifosfamide or doxorubicin monotherapy or doxorubicin and trabectedin.” NCT06333314 ↗ “Trabectedin Presentation: vials with trabectedin 1 mg and sucrose 400 mg.” NCT01104298 ↗ “Study drugs include trabectedin and rifampin.” NCT01273480 ↗ |
| Known as | Ecteinascidin | “A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules” NCT00060944 ↗ |
| Known as | Ecteinascidin-743 | “While investigating the novel anticancer drug ecteinascidin 743 (Et743), a natural marine product isolated from the Caribbean sea squirt, we discovered a new cell-killing...” PMID 11479630 ↗ Aug 2001 |
| Known as | ET-743 | “The cytotoxic activity of ecteinascidin 743 (ET-743), a natural product derived from the marine tunicate Ecteinascidia turbinata that exhibits potent anti-tumor activity in...” PMID 11304695 ↗ May 20016“While investigating the novel anticancer drug ecteinascidin 743 (Et743), a natural marine product isolated from the Caribbean sea squirt, we discovered a new cell-killing...” PMID 11479630 ↗ Aug 2001 “A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules” NCT00060944 ↗ “A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours.” PMID 15177491 ↗ Jun 2004 “ET-743, Yondelis (vials of 1 mg). Route of administration: intravenous infusion” NCT05131386 ↗ “Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])” NCT01453283 ↗ |
| Known as | YONDELIS | “PURPOSE: To determine the dose-limiting toxicity (DLT) and the maximum tolerated dose of ecteinascidin-743 (ET-743, Yondelis) in children with refractory solid tumors, to...” PMID 15701855 ↗ Jan 20059“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...” NCT01846611 ↗ “A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)” NCT00796120 ↗ “A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma” NCT00579501 ↗ “A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma” NCT01343277 ↗ “A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours.” PMID 15177491 ↗ Jun 2004 “The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin” NCT00102609 ↗ “combination of trabectedin (Yondelis®)” NCT04887961 ↗ “Trabectedin 1 MG [Yondelis]” NCT04067115 ↗ |
| Known as | YONDELIS [R] | “Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])” NCT01453283 ↗ |
| Action | Inhibit | “ET-743 downregulated TLS:CHOP expression” PMID 22293175 ↗ Feb 2012 |
| Modality | Small molecule | “Trabectedin (ET-743) is a marine alkaloid isolated from the Caribbean tunicate Ecteinascidia turbinata, with a chemical structure characterized by three fused...” PMID 20647340 ↗ Jul 2010 |
| Route | Intravenous | “administered as a single intravenous infusion” NCT00002904 ↗ |
| Target | FLI1 | “Trabectedin above a threshold concentration reverses the activity of EWS::FLI1 and is potentiated by low-dose irinotecan in vivo.” PMID 41991689 ↗ Apr 2026 |