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zoliflodacin 🐶 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 | 5793 | 1620458-09-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Zoliflodacin is a spiropyrimidinetrione inhibitor of the bacterial type II topoisomerases (DNA gyrase and topoisomerase IV), which are required for DNA synthesis. Zoliflodacin binds within the cleaved DNA–gyrase complex, blocking re-ligation, and interacts with conserved amino acids in the gyrase B subunit.
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 |
|---|---|---|---|
| Dec. 12, 2025 | FDA | Entasis Therapeutics, Inc. |
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 |
|---|---|---|
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D059003 | Topoisomerase Inhibitors |
| MeSH PA | D059005 | Topoisomerase II Inhibitors |
| CHEBI has role | CHEBI:156203 | topoisomerase II inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Gonorrhea | indication | 15628003 | DOID:7551 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | 9040528 | Oct. 13, 2029 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA DUE TO NEISSERIA GONORRHOEAE |
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | 8889671 | Jan. 21, 2034 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA DUE TO NEISSERIA GONORRHOEAE |
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | 9187495 | Jan. 21, 2034 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA DUE TO NEISSERIA GONORRHOEAE |
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | 9540394 | Jan. 21, 2034 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA DUE TO NEISSERIA GONORRHOEAE |
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | 9839641 | Jan. 21, 2034 | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA DUE TO NEISSERIA GONORRHOEAE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | Dec. 12, 2030 | NEW CHEMICAL ENTITY |
| 3GM/PACKET | NUZOLVENCE | ENTASIS THERAP | N219491 | Dec. 12, 2025 | RX | FOR SUSPENSION | ORAL | Dec. 12, 2035 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| R8U | PDB_CHEM_ID |
| CHEMBL3544978 | ChEMBL_ID |
| C000599190 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB12817 | DRUGBANK_ID |
| C4519225 | UMLSCUI |
| CHEBI:747123 | CHEBI |
| 10285 | INN_ID |
| D11726 | KEGG_DRUG |
| 76685216 | PUBCHEM_CID |
| 44621 | MMSL |
| d10359 | MMSL |
| 020311 | NDDF |
| 10875 | IUPHAR_LIGAND_ID |
| FWL2263R77 | UNII |
| 2734122 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| NUZOLVENCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68547-915 | FOR SUSPENSION | 3 g | ORAL | NDA | 30 sections |