Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SBR759 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 1g bid |
| 2 | ACTIVE_COMPARATOR | 0.8 g tid |
| 3 | EXPERIMENTAL | 1.5 g tid |
| 4 | ACTIVE_COMPARATOR | 1.6 g tid |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| 7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SBR759 | DRUG | 1g tid |
| Sevelamer HCl | DRUG | 1.6 g tid |
Inclusion criteria * Men or women of at least 18 years old or 20 years old in Japan. * Stable maintenance of hemodialysis 3 times per week. * Controlled serum phosphate if under phosphate-binder therapy. * Serum phosphate level \> 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation. Excl...
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SBR759 is an investigational small molecule being developed for hyperphosphatemia in patients with chronic kidney disease on 3x/week replacement therapy, and for chronic kidney disease. It is designed to lower serum phosphate levels in these patient populations.
SBR759 is being developed by Novartis AG (NVS). The company has conducted clinical trials evaluating the drug's efficacy in lowering serum phosphate levels in chronic kidney disease patients on hemodialysis.
SBR759 is in Phase 2 clinical development. Two Phase 2 trials have been completed, along with one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.
SBR759 has been studied in two completed Phase 2 trials: NCT00704483, which enrolled 321 patients with hyperphosphatemia on 3x/week replacement therapy, and NCT00704678, which enrolled 203 Asian chronic kidney disease patients on hemodialysis. A Phase 1 trial, NCT00750295, enrolled 60 patients.
SBR759 is a phosphate binder. It works by binding to phosphate in the gastrointestinal tract, reducing its absorption and thereby lowering serum phosphate levels in patients with chronic kidney disease.