Relmada Therapeutics Wins FDA Nod for Single-Arm NDV-01 Bladder Cancer Trial
FDA aligned with Relmada Therapeutics on a single-arm, open-label pivotal trial design for NDV-01 in second-line refractory high-grade non-muscle invasive bladder cancer, representing the fastest approval pathway. Relmada plans to initiate both registrational studies in the first half of 2026.
1. FDA Aligns on Registrational Pathway for NDV-01
In January 2026 the FDA confirmed its alignment on the registrational development pathway for NDV-01, Relmada Therapeutics’ sustained-release intravesical formulation of gemcitabine and docetaxel for second-line refractory high-grade non-muscle invasive bladder cancer. The agency indicated that a single-arm, open-label pivotal trial is appropriate for the carcinoma in situ population, representing a streamlined approval approach.
2. Trial Initiation and Future Outlook
Relmada plans to initiate both pivotal trials in the first half of 2026, marking the fastest route to potential market authorization. NDV-01 could become an in-office, bladder-sparing therapy for patients with few effective alternatives, and positive trial results may significantly de-risk the asset for investors.