Relmada’s New Phase 3 Bladder Cancer Trial Adds a Fresh Catalyst to Its Pipeline

Relmada Therapeutics Inc (RLMD) announced an update on their ongoing clinical study.

Study Overview

Relmada Therapeutics Inc. is preparing a Phase 3 trial titled “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.” The study will test whether NDV-01 can safely control bladder cancer in patients who no longer respond to standard BCG treatment and have also failed first-line options, but are still candidates for bladder removal surgery. This group has limited choices today, so any positive data could fill an important treatment gap and support a new late-stage asset in Relmada’s pipeline.

Intervention/Treatment

The trial will evaluate NDV-01, a drug that combines gemcitabine and docetaxel in a sustained-release form. It is given directly into the bladder (intravesical) with the aim of controlling or reducing tumors while avoiding full bladder removal. The goal is to offer a bladder-sparing option for patients who have run out of approved therapies after BCG failure.

Study Design

This is an interventional Phase 3 trial with a single treatment group. All enrolled patients will receive NDV-01; there is no randomization and no comparison arm. The study is open-label, meaning doctors and patients know they are receiving NDV-01. The main purpose is treatment, focusing on how well NDV-01 works and how safe it is in this advanced, hard-to-treat NMIBC setting.

Study Timeline

The study was first submitted to the registry on January 13, 2026, which signals the formal planning stage and near-term site activation. The overall status is “not yet recruiting,” so patient enrollment has not started but is expected once approvals and logistics are in place. The same date, January 13, 2026, is shown as the last update, indicating the protocol is newly posted and may evolve as sites open. Primary completion and final completion dates are not yet listed, which is typical at this early point and suggests a multi-year path before full data readout.

Market Implications

For investors, this new Phase 3 effort gives Relmada a potential value driver outside its core CNS focus and positions the company in the high-need bladder cancer niche. While the trial is still pre-enrollment and no clinical outcomes are available, the move into late-stage oncology can support a higher perceived pipeline value and may improve sentiment among long-term holders who favor derisked, Phase 3 assets. Near term, the update is more likely to influence narrative and catalyst expectations than fundamentals, as revenue impact remains distant. Competitive pressure in non-muscle invasive bladder cancer is intense, with multiple BCG-unresponsive programs from larger oncology players in development, so investors should watch for signs of differentiated safety, durable response, and real-world usability. Any future positive interim signals or regulatory designations could act as catalysts, but the current update mainly confirms Relmada’s intent to compete in this space and adds another track to the company’s development story.

The NDV-01 Phase 3 bladder cancer study is active at the planning stage and has been recently updated, with more details available on the ClinicalTrials.gov portal.

To learn more about RLMD’s potential, visit the Relmada Therapeutics Inc drug pipeline page.