Relmada readies Phase 3 NDV-01 bladder cancer trial after 95% Phase 2 CR rate
RESCUE has not yet started recruiting, but the initial 3-month readout Relmada guided to by year-end 2026 will be the first Phase 3 test of a Phase 2 complete-response signal that topped 94% in BCG-unresponsive patients.
Executive Summary
- Relmada Therapeutics is moving its NDV-01 bladder cancer program into a registrational Phase 3 trial, with an initial readout guided for the end of 2026, on the strength of complete-response rates from earlier-stage data that ran well above typical rates for this hard-to-treat population.
- The trial's efficacy readout in BCG-unresponsive patients is designed around complete response, the same measure that produced the Phase 2 signal, giving the sponsor a direct basis for comparison when initial data return.
- The Phase 3 study has not yet begun recruiting patients even as the sponsor holds to a year-end 2026 data window, meaning the near-term timeline depends on enrollment starting and moving on schedule rather than on any clinical uncertainty already resolved.
- No trial in this indication shares NDV-01's molecular target, so the readout's value lies in how it compares against the intravesical and BCG-unresponsive treatment landscape broadly, rather than against a single named rival.
The catalyst
Relmada expects initial 3-month data from the Phase 3 RESCUE trial of NDV-01 in second-line BCG-unresponsive NMIBC by year-end 2026, the company said in its first-quarter 2026 update. The trial, registered as NCT07464145, tests NDV-01 by intravesical instillation, delivered directly into the bladder, in patients who have recurred after first-line intravesical therapy. The primary efficacy measure in this cohort is complete response at any time, the same endpoint used in the drug's earlier-stage data. Relmada+1Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdateMay 12, 2026A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder CancerNCT07464145
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The bar the data must clear
Relmada's Phase 2 data, reported alongside the Phase 3 initiation update, showed a 95% complete response rate at any time and a 76% durable complete response rate at 12 months in high-risk NMIBC, and a 94% complete response rate at any time with an 80% durable rate at 12 months in the BCG-unresponsive subgroup specifically. Those figures set the reference the Phase 3 readout will be measured against: an initial 3-month signal that approaches the 94% any-time complete response rate from Phase 2 would extend the earlier result into a randomized, registrational setting; a rate that falls back toward historical intravesical-chemotherapy response levels would narrow the gap the company has described between NDV-01 and existing options. RelmadaRelmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdateMay 12, 2026
Where the trial sits operationally
The trial is registered as Not yet recruiting, with a planned start date of June 1, 2026, and an anticipated enrollment of 393 patients across cohorts spanning intermediate-risk and BCG-unresponsive NMIBC. The registered primary completion date is September 1, 2029, well beyond the December 2026 window the company has guided to for the first readout. That gap reflects the fact that the December 2026 guidance covers an initial 3-month efficacy look, not the trial's full primary completion, and Relmada has held that guidance steady across at least two prior disclosures dating to March 2026. No enrollment target change, protocol amendment to the primary endpoints, or completion-date revision has been recorded since the trial was first posted in March 2026. NCT07464145+1A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder CancerNCT07464145Relmada Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdateMay 12, 2026
The competitive frame
NDV-01's molecular target is not established in available registry data, so the BCG-unresponsive NMIBC field is best characterized by modality and indication rather than by a shared mechanism. Among trials in NMIBC and bladder cancer more broadly, comparators use materially different mechanisms, including CG Oncology's oncolytic virus cretostimogene grenadenorepvec in the same BCG-unresponsive setting and Suzhou Suncadia's PD-L1-directed antibody-drug conjugate in bladder cancer generally, underscoring that intravesical chemotherapy combinations like NDV-01 compete against a mechanistically diverse field rather than a narrow set of direct rivals. No validated disease-modifying mechanism has replaced BCG as standard of care in this population, which is why a complete-response rate that holds near the Phase 2 range, sustained past the initial 3-month look, would be the result that distinguishes the Phase 3 program from earlier attempts to improve on intravesical chemotherapy alone.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.