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gepotidacin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibiotics, DNA gyrase and topoisomerase IV inhibitors | 5765 | 1075236-89-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
BLUJEPA is a triazaacenaphthylene antibacterial that inhibits Type II topoisomerases including bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, thereby inhibiting DNA replication.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 25, 2025 | FDA | GSK |
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 | J01XX13 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Other antibacterials |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D059003 | Topoisomerase Inhibitors |
| FDA MoA | N0000000177 | Cholinesterase Inhibitors |
| FDA MoA | N0000020087 | Topoisomerase 4 Inhibitors |
| FDA MoA | N0000020088 | Topoisomerase 2 Inhibitors |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA EPC | N0000194142 | Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor |
| CHEBI has role | CHEBI:33282 | antibacterial agent |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
Related Drugs by ATC class:
J01XX Other antibacterials 12 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Urinary tract infections | indication | 68566005 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | 8389524 | Feb. 12, 2029 | TREATMENT OF FEMALE ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 40 KG WITH UNCOMPLICATED URINARY TRACT INFECTIONS (UUTI) CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, ENTEROCOCCUS FAECALIS |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | 10702521 | Aug. 20, 2035 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 45 KG WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS WITH UNCOMPLICATED UROGENITAL GONORRHEA CAUSED BY SUSCEPTIBLE STRAINS OF NEISSERIA GONORRHOEAE |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | 11229646 | Aug. 20, 2035 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 45 KG WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS WITH UNCOMPLICATED UROGENITAL GONORRHEA CAUSED BY SUSCEPTIBLE STRAINS OF NEISSERIA GONORRHOEAE |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | 12528809 | Dec. 13, 2042 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 45 KG WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS WITH UNCOMPLICATED UROGENITAL GONORRHEA CAUSED BY SUSCEPTIBLE STRAINS OF NEISSERIA GONORRHOEAE |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | 12528809 | Dec. 13, 2042 | TREATMENT OF FEMALE ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 40 KG WITH UNCOMPLICATED URINARY TRACT INFECTIONS (UUTI) CAUSED BY E. COLI, K. PNEUMONIAE, CITROBACTER FREUNDII COMPLEX, S. SAPROPHYTICUS, E. FAECALIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | Dec. 11, 2028 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA CAUSED BY SUSCEPTIBLE STRAINS OF NEISSERIA GONORRHOEAE IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 45 KILOGRAMS WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | March 25, 2030 | NEW CHEMICAL ENTITY |
| EQ 750MG BASE | BLUJEPA | GLAXOSMITHKLINE | N218230 | March 25, 2025 | RX | TABLET | ORAL | March 25, 2035 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| DNA topoisomerase 2-alpha | Enzyme | IC50 | 4.26 | CHEMBL | |||||
| DNA topoisomerase 4 subunit A | Enzyme | INHIBITOR | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL3317856 | ChEMBL_ID |
| C000612856 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10817 | IUPHAR_LIGAND_ID |
| DB12134 | DRUGBANK_ID |
| 4044237 | VANDF |
| C4309999 | UMLSCUI |
| CHEBI:747127 | CHEBI |
| JHN | PDB_CHEM_ID |
| 10050 | INN_ID |
| D10878 | KEGG_DRUG |
| 25101874 | PUBCHEM_CID |
| 393591 | MMSL |
| d10264 | MMSL |
| 020037 | NDDF |
| DVF0PR037D | UNII |
| 2709212 | RXNORM |
Pharmaceutical products:
None