Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LP-08 · 1 trial · 1 indication
The number/severity of adverse events throughout the study
| Arm | Type | Description |
|---|---|---|
| LP-08 80mg | ACTIVE_COMPARATOR | 4 weekly intravesical administration of LP-08 80mg |
| LP-08 20mg | ACTIVE_COMPARATOR | 4 weekly intravesical administration of LP-08 20mg |
| Normal Saline | PLACEBO_COMPARATOR | Four weekly normal saline intravesical administration |
| Name | Type | Description |
|---|---|---|
| LP-08 80mg | DRUG | Intravesical instillation of 80mg LP08 |
| Normal saline | DRUG | Intravesical instillation of normal saline |
| LP-08 20mg | DRUG | Intravesical instillation of 20mg LP08 |
Inclusion Criteria: A patient is deemed suitable for inclusion in the study if the patient meets the following criteria: 1. Male or female at least 18 years of age 2. IC/BPS diagnosed by a health care provider based the following criteria: Complaint of suprapubic pain related to bladder fillin...
LP-08 is an investigational small molecule developed by Lipella Pharmaceuticals Inc. (ticker LIPO) for interstitial cystitis, also known as painful bladder syndrome. It is delivered intravesically, meaning directly into the bladder, and has been studied in a Phase 2 clinical trial in the United States.
LP-08 is being developed to treat interstitial cystitis, a chronic bladder condition also called painful bladder syndrome. The Phase 2 study evaluated intravesical LP-08 in patients with this condition. LP-08 is investigational and has not been approved by the FDA for any indication.
LP-08 is developed by Lipella Pharmaceuticals Inc., which trades under the ticker LIPO. The company sponsored the Phase 2 clinical trial of intravesical LP-08 in patients with interstitial cystitis or painful bladder syndrome conducted in the United States.
LP-08 is in Phase 2 development. Its single clinical trial, NCT01393223, was a completed Phase 2 study of intravesical LP-08 in patients with interstitial cystitis or painful bladder syndrome. LP-08 is investigational and has not been approved by the FDA.
LP-08 has been studied in one clinical trial, NCT01393223, titled Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome. It was a completed Phase 2 trial that enrolled 21 patients in the United States. The study was randomized, double blind, and placebo controlled.