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 | 2020-09-22 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
TRABECTEDIN, YONDELIS, JANSSEN PRODS | |||
2023-04-23 | PED |
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
90 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 | 4 | 5 | 1 | 3 | 14 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 5 | 3 | — | — | — | 8 | |
Myxoid liposarcoma | D018208 | 1 | 4 | — | — | — | 4 | ||
Ewing sarcoma | D012512 | EFO_0000173 | 1 | 1 | — | — | 1 | 3 | |
Ovarian epithelial carcinoma | D000077216 | — | 1 | — | — | 1 | 2 | ||
Malignant mesothelioma | D000086002 | — | 2 | — | — | — | 2 | ||
Neoplasm metastasis | D009362 | EFO_0009708 | 2 | 1 | — | — | — | 2 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | — | — | — | 2 | |
Neoplasms by site | D009371 | — | 2 | — | — | — | 2 | ||
Rhabdomyosarcoma | D012208 | — | 1 | — | — | 1 | 2 |
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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 | 1716278 |
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,301 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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362 adverse events reported
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