Trial Profile

A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 20 Mar 2026

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At a glance

17 Mar 2026 Status changed from not yet recruiting to withdrawn prior to enrolment. (: This study has been incorporated into the Relmada REL-NDV01-303 study.)
09 Mar 2026 According to a Relmada Therapeutics media release, the two separate registrational pathways within the trial, second line BCG-unresponsive and adjuvant intermediate-risk, which is expected to initiate in mid-2026 with initial data expected by end of 2026.
17 Jan 2026 Status changed from planning to not yet recruiting.

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