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
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 |
---|---|---|---|---|
ZEPZELCA | Jazz Pharmaceuticals | N-213702 RX | 2020-06-15 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
zepzelca | New Drug Application | 2020-06-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
small cell lung carcinoma | — | D055752 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
LURBINECTEDIN, ZEPZELCA, JAZZ | |||
2027-06-15 | ODE-304 | ||
2025-06-15 | NCE |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Lurbinectedin, Zepzelca, Jazz | |||
7763615 | 2024-12-13 | DS, DP | U-2836 |
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 carcinoma | D055752 | 4 | 4 | 4 | — | 2 | 12 | ||
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 1 | 1 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 11 | 7 | — | — | — | 15 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 2 | — | — | — | 4 |
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | — | 3 |
Sarcoma | D012509 | 2 | 3 | — | — | — | 3 | ||
Non-small-cell lung carcinoma | D002289 | 1 | 1 | — | — | — | 2 | ||
Colorectal neoplasms | D015179 | 2 | 1 | — | — | — | 2 | ||
Endometrial neoplasms | D016889 | EFO_0004230 | 2 | 2 | — | — | — | 2 | |
Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 2 | 1 | — | — | — | 2 |
Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 2 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 1 | — | — | — | 1 |
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | LURBINECTEDIN |
INN | lurbinectedin |
Description | Lurbinectedin, sold under the brand name Zepzelca, is a medication used for the treatment of small cell lung cancer.
|
Classification | Small molecule |
Drug class | ecteinascidin 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-ID | 497871-47-3 |
RxCUI | — |
ChEMBL ID | CHEMBL4297516 |
ChEBI ID | — |
PubChem CID | 57327016 |
DrugBank | DB12674 |
UNII ID | 2CN60TN6ZS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zepzelca - Jazz Pharmaceuticals
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€
£
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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
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26,193 adverse events reported
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