Trial Profile

A phase 3 study of NDV-01

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 15 Dec 2025

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At a glance

13 Nov 2025 According to a Relmada Therapeutics media release, the company look forward to working with the FDA to establish the final study design and initiate the registrational program in the first half of 2026.
04 Nov 2025 According to a Relmada Therapeutics media release, the company announced that the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The Company will be requesting follow-up meetings with FDA to discuss each development path.
15 Jul 2025 According to a Relmada Therapeutics media release, this trial is expected to begin in H1 2026.

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