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Drug ReportsTrabectedin
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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EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
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
YONDELISJohnson & JohnsonN-207953 RX2015-10-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
yondelisNew Drug Application2020-09-22
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
88955572028-01-07DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01C: Plant alkaloids and other natural products, antineoplastic drugs
— L01CX: Other plant alkaloids and natural products in atc
— L01CX01: Trabectedin
HCPCS
Code
Description
J9352
Injection, trabectedin, 0.1 mg
Clinical
Clinical Trials
106 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 neoplasmsD010051EFO_0003893C561751721
Ovarian epithelial carcinomaD000077216——1521716
RecurrenceD012008———21137
HypersensitivityD006967HP_0012393T78.40———134
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——9218—1548
LeiomyosarcomaD007890——4115—118
LiposarcomaD008080——374—113
NeoplasmsD009369—C80541——10
Fallopian tube neoplasmsD005185———12——3
Peritoneal neoplasmsD010534———11——2
Synovial sarcomaD013584————1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neoplasm metastasisD009362EFO_0009708—32———4
Myxoid liposarcomaD018208——14———4
CarcinomaD002277—C80.012———3
Ewing sarcomaD012512EFO_0000173—12——13
Malignant mesotheliomaD000086002———2———2
MesotheliomaD008654—C45—2———2
Breast neoplasmsD001943EFO_0003869C50—2———2
Endometrial neoplasmsD016889EFO_0004230——2———2
Uterine neoplasmsD014594EFO_0003859C55—2———2
Neoplasms by siteD009371———2———2
Show 36 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver failureD017093HP_0001399K72.91————1
Hepatic insufficiencyD048550——1————1
Neoplasms by histologic typeD009370——1————1
Connective and soft tissue neoplasmsD018204——1————1
Bone neoplasmsD001859EFO_0003820D161————1
LeukemiaD007938—C951————1
LymphomaD008223—C85.91————1
B-cell chronic lymphocytic leukemiaD015451—C91.11————1
Lymphoid leukemiaD007945—C911————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Malignant fibrous histiocytomaD051677——————11
HemangioendotheliomaD006390——————11
NeutropeniaD009503—D70————11
VomitingD014839HP_0002013R11.1————11
Chemotherapy-induced febrile neutropeniaD064146——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTrabectedin
INNtrabectedin
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 classecteinascidin derivatives
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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-ID114899-77-3
RxCUI—
ChEMBL IDCHEMBL450449
ChEBI ID84050
PubChem CID108150
DrugBankDB05109
UNII IDID0YZQ2TCP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
NR1I2
NR1I2
Organism
Homo sapiens
Gene name
NR1I2
Gene synonyms
PXR
NCBI Gene ID
8856
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
Q9UNW4
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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,095 adverse events reported
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