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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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 | 2023-07-28 |
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 | 2029-12-13 | DS, DP | U-2836 |
HCPCS
Code | Description |
|---|---|
| J9223 | Injection, lurbinectedin, 0.1 mg |
Clinical
Clinical Trials
56 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 | — | — | 6 | 10 | 6 | — | 3 | 23 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 6 | 6 | — | 2 | 17 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 1 | 1 | — | — | 4 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | 1 | 1 | — | — | 3 |
| Leiomyosarcoma | D007890 | — | — | 1 | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 11 | 8 | — | — | — | 16 |
| Sarcoma | D012509 | — | — | 7 | 8 | — | — | — | 8 |
| Small cell carcinoma | D018288 | — | — | 3 | 5 | — | — | — | 6 |
| Carcinoma | D002277 | — | C80.0 | 2 | 5 | — | — | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 2 | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 2 | — | — | — | 3 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 3 | 3 | — | — | — | 3 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 2 | 2 | — | — | — | 3 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 3 | 3 | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 2 | 1 | — | — | — | 2 |
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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 neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Acute disease | D000208 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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
No data
Variants
No data
Financial
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Zepzelca – Jazz Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 738 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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703 adverse events reported
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