donepezil/nebivolol (NDC011) / Dr. Noah Biotech - LARVOL DELTA

DR.NOAH BIOTECH’s AI-driven ALS Medicine Receives U.S. FDA Approval for Phase 1 Clinical Trial IND (GlobeNewswire) - "DR.NOAH BIOTECH...announced on August 23 that it had received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for Phase 1 clinical trial of a new drug combination (NDC-011) for Amyotrophic Lateral Sclerosis (ALS)...The study is designed to compare and evaluate the bioavailability, safety, and tolerability of single doses of the individual drugs composing NDC-011, which is a two-drug combination, and NDC-011 itself. The Phase 1 trial is scheduled to begin in the first half of 2025, while Phase 2 is expected to start in 2026."

IND • New P1 trial • New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

Therapeutic Effects of Combination of Nebivolol and Donepezil: Targeting Multifactorial Mechanisms in ALS. (PubMed, Neurotherapeutics) - "Although two FDA-approved drugs, riluzole and edaravone, targeting excitotoxicity and oxidative stress, respectively, are available, their efficacies are limited to extending survival by only a few months. High-dose nebivolol-donepezil significantly prolonged survival and delayed disease onset compared with vehicle-treated mice. These results indicate that the combination of nebivolol-donepezil efficiently prevents ALS disease progression, benefiting the patients' quality of life and life expectancy."

Journal • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFH

Orphan Designation: Treatment of Amyotrophic Lateral Sclerosis (FDA) - Date Designated: 09/28/2023

Orphan drug • Amyotrophic Lateral Sclerosis • CNS Disorders