Trial Profile

A Phase 2b clinical trial for LP-10 for the treatment of hemorrhagic cystitis

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 15 Apr 2025

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At a glance

08 Apr 2025 According to a Lipella Pharmaceuticals media release, the company is on track to submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025
27 Aug 2024 According to a Lipella Pharmaceuticals media release,The company expects to initiate Phase 2b clinical trial in 1 st half 2025.
21 May 2024 According to a Lipella Pharmaceuticals media release, the company received type C meeting guidance from FDA. The FDA provided preliminary agreement on overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations. The company expects to initiate Phase 2b clinical trial in 2H 2024.

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