Relmada Therapeutics, Inc.

NDV-01 for NMIBC

NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) designed to enable prolonged bladder exposure and consistent local drug delivery while simplifying administration in the clinical setting.

Phase 2 clinical data demonstrate durable complete responses with a favorable safety profile, supporting a strong and differentiated clinical profile.

NDV-01 is designed to overcome key limitations of conventional Gem/Doce, including complex preparation and prolonged instillation, through a ready-to-use formulation administered in-office <5 minutes. Importantly, these features are aligned with the needs of community urology practices, where approximately 80% of NMIBC patients are treated, supporting broad real-world adoption beyond academic centers.

The program is advancing into the Phase 3 RESCUE registrational program, expected to initiate in mid-2026, with two independent approval pathways in second-line (2L) BCG-unresponsive NMIBC and in the adjuvant setting for intermediate-risk NMIBC. Together, these pathways provide a clear and efficient route to approval across both difficult-to-treat and large patient populations.

Sepranolone

Sepranolone is a novel clinical candidate with a differentiated mechanism of action targeting compulsive behaviors through modulation of GABA_A receptor activity.

Prior clinical and preclinical data support the potential for Sepranolone to have a beneficial effect on food craving, appetite and compulsive behaviors.

Sepranolone is advancing toward a Phase 2 clinical trial in Prader-Willi syndrome, with initiation expected in mid-2026, to further evaluate safety, tolerability, and effects on behavioral and appetite-related outcomes.