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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

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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: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2026

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At a glance

  • Drugs Docetaxel/gemcitabine (Primary)
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms RESCUE
  • Sponsors Relmada Therapeutics

Most Recent Events

  • 17 Jan 2026 Status changed from planning to not yet recruiting.
  • 12 Jan 2026 According to a Relmada Therapeutics media release, in its written response to Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01.
  • 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.

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