Yondelis(trabectedin)
Yondelis (trabectedin) is a small molecule pharmaceutical. Trabectedin was first approved as Yondelis on 2007-09-17. It is used to treat leiomyosarcoma and liposarcoma in the USA. It has been approved in Europe to treat ovarian neoplasms and sarcoma. It is known to target nuclear receptor subfamily 1 group I member 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Yondelis
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trabectedin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| YONDELIS | Johnson & Johnson | N-207953 RX | 2015-10-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| yondelis | New Drug Application | 2024-12-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| leiomyosarcoma | — | D007890 | — |
| liposarcoma | — | D008080 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Trabectedin, Yondelis, Janssen Prods | |||
| 8895557 | 2028-01-07 | DP | |
HCPCS
Code | Description |
|---|---|
| J9352 | Injection, trabectedin, 0.1 mg |
Clinical
Clinical Trials
108 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 8 | 5 | 1 | 7 | 22 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | 7 | 3 | 1 | 7 | 19 |
| Recurrence | D012008 | — | — | — | 2 | — | 1 | 3 | 6 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | 3 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 8 | 20 | 8 | — | 15 | 47 |
| Leiomyosarcoma | D007890 | — | — | 4 | 12 | 5 | — | 1 | 19 |
| Liposarcoma | D008080 | — | — | 3 | 7 | 4 | — | 1 | 13 |
| Neoplasms | D009369 | — | C80 | 5 | 4 | 1 | — | — | 10 |
| Fallopian tube neoplasms | D005185 | — | — | — | 1 | 1 | — | — | 2 |
| Synovial sarcoma | D013584 | — | — | — | — | 1 | — | 1 | 2 |
| Peritoneal neoplasms | D010534 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 2 | — | — | — | 4 |
| Myxoid liposarcoma | D018208 | — | — | 1 | 4 | — | — | — | 4 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | 2 | — | — | 1 | 3 |
| Malignant mesothelioma | D000086002 | — | — | — | 2 | — | — | — | 2 |
| Mesothelioma | D008654 | — | C45 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 2 | — | — | — | 2 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 2 | — | — | — | 2 |
| Neoplasms by site | D009371 | — | — | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | — | — | — | — | 1 |
| Connective and soft tissue neoplasms | D018204 | — | — | 1 | — | — | — | — | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malignant fibrous histiocytoma | D051677 | — | — | — | — | — | — | 1 | 1 |
| Hemangioendothelioma | D006390 | — | — | — | — | — | — | 1 | 1 |
| Neutropenia | D009503 | — | D70 | — | — | — | — | 1 | 1 |
| Vomiting | D014839 | — | R11.1 | — | — | — | — | 1 | 1 |
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Trabectedin |
| INN | trabectedin |
| Description | Trabectedin is a tetrahydroisoquinoline alkaloid obtained from a Caribbean tunicate Ecteinascidia turbinata. Used for the treatment of soft tissue sarcoma and relapsed ovarian cancer. It has a role as an antineoplastic agent, a marine metabolite, an anti-inflammatory agent, an angiogenesis modulating agent and an alkylating agent. It is an organic heteropolycyclic compound, an azaspiro compound, an oxaspiro compound, a bridged compound, a lactone, a polyphenol, an acetate ester, a hemiaminal, an organic sulfide, a tertiary amino compound and an isoquinoline alkaloid. |
| Classification | Small molecule |
| Drug class | ecteinascidin derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2c(cc1O)CCN[C@]21CS[C@@H]2c3c(OC(C)=O)c(C)c4c(c3[C@H](COC1=O)N1[C@@H](O)[C@@H]3Cc5cc(C)c(OC)c(O)c5[C@H]([C@H]21)N3C)OCO4 |
Identifiers
| PDB | — |
| CAS-ID | 114899-77-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL450449 |
| ChEBI ID | 84050 |
| PubChem CID | 108150 |
| DrugBank | DB05109 |
| UNII ID | ID0YZQ2TCP (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR1I2
NR1I2
Organism
Homo sapiens
Gene name
NR1I2
Gene synonyms
PXR
NCBI Gene ID
Protein name
nuclear receptor subfamily 1 group I member 2
Protein synonyms
Orphan nuclear receptor PAR1, Orphan nuclear receptor PXR, Pregnane X receptor, Steroid and xenobiotic receptor, SXR
Uniprot ID
Mouse ortholog
Nr1i2 (18171)
nuclear receptor subfamily 1 group I member 2 (O54915)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,665 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,292 adverse events reported
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