Gepotidacin API is a synthetic, orally active antibacterial agent belonging to the triazaacenaphthylene class. It is a first-in-class bacterial topoisomerase inhibitor that targets DNA gyrase and topoisomerase IV, providing a mechanism distinct from conventional fluoroquinolone antibacterials. Gepotidacin is also known by the development code GSK-2140944.
Gepotidacin has the molecular formula C₂₄H₂₈N₆O₃, molecular weight 448.5 g/mol, and CAS Registry Number 1075236-89-3. The FDA substance registry confirms its chemical identity and UNII DVF0PR037D.
The pharmaceutical product BLUJEPA contains gepotidacin mesylate dihydrate. The FDA-approved drug substance is chemically identified as gepotidacin mesylate dihydrate, with molecular formula C₂₄H₂₈N₆O₃·CH₄O₃S·2H₂O and molecular mass 580.66 g/mol.
| Property | Value |
|---|---|
| API Name | Gepotidacin |
| CAS Number | 1075236-89-3 |
| Development Code | GSK-2140944 |
| Molecular Formula | C₂₄H₂₈N₆O₃ |
| Molecular Weight | 448.5 g/mol |
| Chemical Class | Triazaacenaphthylene |
| Pharmacological Class | Bacterial Type II Topoisomerase Inhibitor |
| Primary Targets | DNA gyrase and Topoisomerase IV |
| Stereochemistry | (R) |
| Appearance | Solid |
| Mesylate Dihydrate CAS | 1624306-20-2 |
| Mesylate Dihydrate Molecular Weight | 580.66 g/mol |
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |