Trial Profile

A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants with Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer - HP003-001

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 Sep 2026

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At a glance

21 Sep 2026 Status changed from not yet recruiting to recruiting.
21 Aug 2025 According to a Hamlet Pharma AB media release, the company is engaged with FDA to discuss submission requirements and timelines for a Phase III study.
25 Jun 2025 According to a Hamlet Pharma AB media release, trial design for NMIBC patients, which will support the registration of Alpha1H were submitted to US FDA for approval.

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