Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vepoloxamer · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Normal Renal Function | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 2: Mild Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 3: Moderate Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 4: Severe Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 5: End Stage Renal Disease | EXPERIMENTAL | Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours |
| Name | Type | Description |
|---|---|---|
| Vepoloxamer | DRUG | - |
Key Inclusion Criteria: * Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2 * Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days * If female, subject must not be pregnant or lactating, have a negative pregnan...
Vepoloxamer is an investigational small molecule being studied in nephrology. A Phase 1 clinical trial evaluated its pharmacokinetics in healthy volunteers and in people with renal impairment. The drug is not approved and remains in clinical development.
Vepoloxamer is being developed by Savara, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker SVRA. The company is conducting clinical research on this investigational small molecule.
Vepoloxamer is in Phase 1 clinical development. One Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.
Vepoloxamer has one completed Phase 1 trial, NCT02646358, titled 'Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer.' The study enrolled 27 participants in the United States, including healthy volunteers and renally impaired individuals.
Vepoloxamer is not FDA approved. It is an investigational drug that has completed a Phase 1 pharmacokinetic study. Further clinical development would be required before any regulatory approval could be considered.