lurbinectedin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| ecteinascidin derivatives | 5398 | 497871-47-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Lurbinectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 15, 2020 | FDA | JAZZ |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX69 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| FDA MoA | N0000000236 | Alkylating Activity |
| FDA EPC | N0000175558 | Alkylating Drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Small cell carcinoma of lung | indication | 254632001 | DOID:5409 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 4MG/VIAL | ZEPZELCA | JAZZ | N213702 | June 15, 2020 | RX | POWDER | INTRAVENOUS | 7763615 | Dec. 13, 2024 | TREATMENT OF ADULT PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY. |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 4MG/VIAL | ZEPZELCA | JAZZ | N213702 | June 15, 2020 | RX | POWDER | INTRAVENOUS | June 15, 2025 | NEW CHEMICAL ENTITY |
| 4MG/VIAL | ZEPZELCA | JAZZ | N213702 | June 15, 2020 | RX | POWDER | INTRAVENOUS | June 15, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D11644 | KEGG_DRUG |
| 2CN60TN6ZS | UNII |
| C3898565 | UMLSCUI |
| CHEMBL4297516 | ChEMBL_ID |
| 57327016 | PUBCHEM_CID |
| DB12674 | DRUGBANK_ID |
| 10681 | IUPHAR_LIGAND_ID |
| 018414 | NDDF |
| 879925002 | SNOMEDCT_US |
| 879932006 | SNOMEDCT_US |
| 4039494 | VANDF |
| 2374729 | RXNORM |
| 335658 | MMSL |
| 38550 | MMSL |
| d09579 | MMSL |
| C568606 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9397 | INN_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ZEPZELCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-712 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.50 mg | INTRAVENOUS | NDA | 29 sections |
| ZEPZELCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-712 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.50 mg | INTRAVENOUS | NDA | 29 sections |
| ZEPZELCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-712 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.50 mg | INTRAVENOUS | NDA | 29 sections |