Pipeline
One program. Stated exactly.
A single asset in a single indication, at the stage it is actually at.
| Program | Indication | Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | Registration |
|---|---|---|---|---|---|---|---|
| NNT-001 oral hydralazine |
Alzheimer’s disease | ◂ Pre-IND |
A randomized, placebo-controlled trial of hydralazine in mild to moderate Alzheimer’s disease (NCT04842552) has been conducted by academic investigators at Shahid Sadoughi University of Medical Sciences. NeuroNova is not the sponsor of that trial. Our US registrational program has not yet begun.
We have completed a pre-IND interaction with FDA and hold written Agency responses that define the requirements for a US registrational program. Background on the completed academic trial and the planned US program is on the clinical page.
Hydralazine is an investigational treatment for Alzheimer’s disease. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for this use. Its safety and effectiveness for Alzheimer’s disease have not been established.