Relmada Therapeutics is a clinical-stage biotech developing drug candidates for bladder cancer and neurological disorders. The company generates no revenue and has no approved products. Following the failure of its prior lead drug, esmethadone (REL-1017), in major depressive disorder in 2024, Relmada pivoted its pipeline entirely, acquiring two new clinical-stage programs in early 2025. The first, NDV-01, is a pre-filled, ready-to-use intravesical formulation of the gemcitabine and docetaxel combination chemotherapy regimen for non-muscle invasive bladder cancer (NMIBC), in-licensed from Trigone Pharma. Unlike conventional Gem/Doce, which requires specialized pharmacy preparation and three to five hours to administer, NDV-01 can be administered in a standard urologist's office in under five minutes and releases drugs continuously over ten days. Phase 2 data in 48 patients showed a 95% complete response rate. Two Phase 3 programs are expected to begin in mid-2026. The second program, sepranolone, is a synthetic neurosteroid acquired from Asarina Pharma that blocks anxiety- and compulsion-worsening effects on GABA-A receptors, and is being developed for Prader-Willi syndrome (PWS), Tourette syndrome, and other conditions. A Phase 2 study in PWS is planned for mid-2026. Relmada funds operations through equity raises and has no commercial infrastructure; the path to revenue requires completing Phase 3 trials and either self-commercializing or partnering with larger pharma companies.
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