Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LP-10 · 1 trial · 1 indication
Pre-post changes in mean episodes of visible blood in urine (or blood clots) on 3-day bladder diaries at baseline and primary endpoint
| Arm | Type | Description |
|---|---|---|
| LP-10 2mg | EXPERIMENTAL | LP-10 (intravesical tacrolimus), 2mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed. |
| LP-10 4mg | EXPERIMENTAL | LP-10 (intravesical tacrolimus), 4mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed. |
| LP-10 8mg | EXPERIMENTAL | LP-10 (intravesical tacrolimus), 8mg reconstituted in sterile water for injection, intravesical instillations, up to two instillations, instillations will occur greater than 3 days but less than 7 days apart as needed. |
| Name | Type | Description |
|---|---|---|
| LP-10 | DRUG | Intravesical tacrolimus |
Inclusion Criteria: Males and females, at least 18 years * History of sterile moderate to severe HC (Grade 2-4) for at least 3 months documented in the medical record with at least 1 episode of macroscopic hematuria with or without clot * Previous use of medications and/or treatment(s) for HC with...
LP-10 is an investigational small molecule being developed for the treatment of refractory moderate to severe hemorrhagic cystitis, a condition characterized by bleeding and inflammation of the bladder. It is currently in clinical development and has not been approved by the FDA.
LP-10 is being developed by Lipella Pharmaceuticals Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol LIPO. The company is conducting clinical trials to evaluate the safety and efficacy of LP-10 in patients with hemorrhagic cystitis.
LP-10 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to assess its safety, tolerability, and efficacy in subjects with refractory moderate to severe hemorrhagic cystitis. The drug remains investigational and is not yet approved for commercial use.
LP-10 has been studied in a Phase 2 clinical trial registered under the identifier NCT03129126. This trial, titled "The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis," was conducted in the United States and enrolled 13 participants aged 18 years and older.
Yes, the Phase 2 clinical trial of LP-10 was a controlled, double-blind study. It was not randomized, meaning participants were not randomly assigned to treatment groups. The trial included a control group to compare outcomes against the investigational drug.