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Lurbinectedin
Zepzelca (lurbinectedin) is a small molecule pharmaceutical. Lurbinectedin was first approved as Zepzelca on 2020-06-15. It is used to treat small cell lung carcinoma in the USA.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Zepzelca
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lurbinectedin
Tradename
Company
Number
Date
Products
ZEPZELCAJazz PharmaceuticalsN-213702 RX2020-06-15
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zepzelcaNew Drug Application2020-06-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
small cell lung carcinomaD055752
Agency Specific
FDA
EMA
Expiration
Code
LURBINECTEDIN, ZEPZELCA, JAZZ
2027-06-15ODE-304
2025-06-15NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Lurbinectedin, Zepzelca, Jazz
77636152024-12-13DS, DPU-2836
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01X: Other antineoplastic agents in atc
L01XX: Other antineoplastic agents in atc
L01XX69: Lurbinectedin
HCPCS
Code
Description
J9223
Injection, lurbinectedin, 0.1 mg
Clinical
Clinical Trials
46 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Small cell lung carcinomaD055752444212
Ovarian neoplasmsD010051EFO_0003893C563114
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8011715
Breast neoplasmsD001943EFO_0003869C50324
Pancreatic neoplasmsD010190EFO_0003860C25223
SarcomaD012509233
Non-small-cell lung carcinomaD002289112
Colorectal neoplasmsD015179212
Endometrial neoplasmsD016889EFO_0004230222
Neuroendocrine tumorsD018358EFO_1001901D3A.8212
Lung neoplasmsD008175C34.90112
Stomach neoplasmsD013274EFO_0003897C16111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Head and neck neoplasmsD00625811
Female genital neoplasmsD00583311
Endometrioid carcinomaD01826911
Hepatic insufficiencyD04855011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLURBINECTEDIN
INNlurbinectedin
Description
Lurbinectedin, sold under the brand name Zepzelca, is a medication used for the treatment of small cell lung cancer.
Classification
Small molecule
Drug classecteinascidin derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2[nH]c3c(c2c1)CCN[C@]31CS[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-ID497871-47-3
RxCUI
ChEMBL IDCHEMBL4297516
ChEBI ID
PubChem CID57327016
DrugBankDB12674
UNII ID2CN60TN6ZS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zepzelca - Jazz Pharmaceuticals
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 478 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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26,193 adverse events reported
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