Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications
January 12, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – CNS disorders, FDA, Relmada Therapeutics, carcinoma in situ, clinical trials, high-grade BCG-unresponsive non-muscle invasive bladder cancer, oncology
FDA written feedback supports:
- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS
- a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting
- Phase 3 program expected to initiate in 1H 2026.
12 January 2026 — Florida, US — Relmada Therapeutics, Inc, a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) — one of the highest-risk and most treatment-resistant NMIBC populations — and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies.
In its written response to Relmada’s 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. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need.
The FDA also provided separate, supportive written feedback on the Company’s planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design.
Relmada continues to anticipate initiating both registrational trials in the first half of 2026.
“We are very pleased with the FDA’s alignment on the registrational design for NDV-01 in high-grade BCG-unresponsive NMIBC,” said Raj S. Pruthi, MD, Chief Medical Officer – Oncology at Relmada Therapeutics. “A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives. This study represents the fastest path to approval for NDV-01.”
Dr. Pruthi continued, “We are also encouraged by the FDA’s feedback on our intermediate-risk registration plans, where we believe NDV-01 could potentially provide meaningful clinical benefit to patients where no approved treatments currently exist.”
About Relmada Therapeutics, Inc
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs. For more information, visit www.relmada.com
