Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Renazorb/day · 1 trial · 2 indications
Efficacy will be evaluated by comparing difference in urine and fecal phosphorous excretion before and after treatment.
| Arm | Type | Description |
|---|---|---|
| Group B | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Group C | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Group D | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
| Group A | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Name | Type | Description |
|---|---|---|
| Renazorb 1500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 3000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Renazorb 4500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 6000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
Inclusion Criteria: * Healthy male and female volunteers ≥ 18 years of age without history of significant medical disease will be enrolled. Exclusion Criteria:
Renazorb/day is an investigational small molecule being developed by Assertio Holdings, Inc. (ASRT). It is currently in Phase 1 clinical development for safety and phosphate binding capacity. The drug is not FDA approved and remains in clinical testing.
Renazorb/day is being developed by Assertio Holdings, Inc., a biopharmaceutical company traded on the stock exchange under the ticker ASRT. The company is conducting clinical trials to evaluate the drug's safety and phosphate binding capacity.
Renazorb/day is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Renazorb/day has one completed Phase 1 clinical trial, identified as NCT01560884. This study assessed the safety and phosphate binding capacity of the drug in 32 participants in the United States. The trial was randomized, double-blind, and active-controlled.
No, Renazorb/day is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety and phosphate binding capacity, but the drug has not yet received regulatory approval.