Drug intelligence / Profile preview

NDV-01

Development stage
Phase 3
Lead developer
Relmada Therapeutics
Modality
Small Molecules
Administration
Intravesical
01

Overview

**NDV-01** is an investigational, ready-to-use sustained-release intravesical formulation of the antineoplastic agents gemcitabine and docetaxel for non-muscle invasive bladder cancer. It forms a soft intravesical matrix intended to retain the drugs in the bladder and gradually release them locally for approximately 10 days, increasing tumor exposure while limiting systemic exposure. The program originated at Trigone Pharma and was licensed to Relmada, which is advancing the asset through an ongoing Phase 2 study and preparing registrational development following a planned United States IND submission. ([ir.relmada.com](https://ir.relmada.com/press_releases/relmada-therapeutics-licenses-phase-2-bladder-cancer-candidate-ndv-01-from-trigone-pharma-ltd/))

Other names
GEM/DOCE sustained-release formulationgemcitabine docetaxel combination agent
02

Targets

DNA polymerase family

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