Receptor Occupancy & Binding Kinetics (D3 Engine)
● Ubesol vs
● Ubesol N
Systemic pH Condition
7.4
Plasma Dose Level (mg)
50 mg
Ubesol N Dissociation (Kd)
1.1 nM
Pharmacological Telemetry & AUC
Ubesol Peak Occupancy
0%
AUC: 0 %·h
Ubesol N Peak Occupancy
0%
AUC: 0 %·h
PMDA Submission Difference Matrix
| Parameter | Ubesol Standard | Ubesol N (Novel Salt) |
|---|---|---|
| Active Salt Form | Free Base / HCl | N-Methylated / Tosylate |
| Optimum pH | 6.8 (Gastric Dependent) | 7.4 (Systemic Stable) |
| Primary Indication | Acute Episode Relief | Maintenance & Extended Target |
| Half-Life (t½) | 6.5 hrs | 11.2 hrs |
PMDA Submission & Interview Form Summary
Ubesol N contains a modified active salt structure that resists rapid hepatic clearance, achieving an extended half-life (11.2h vs 6.5h) and enhanced binding affinity under physiological pH 7.4.