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NFL-301

Development stage: Preclinical
Lead developer: NFL Biosciences
Modality: Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration: Oral

Overview

NFL-301 is a botanical drug candidate developed by NFL Biosciences for the treatment of alcohol use disorder (AUD) and the reduction of excessive alcohol consumption. The drug is a proprietary, standardized extract of kudzu (*Pueraria lobata*) formulated as sustained-release microgranules. This formulation is designed to provide a pharmaceutical-grade alternative to traditional kudzu preparations, aiming to improve efficacy and patient compliance through optimized delivery and standardized dosing. NFL-301 is currently in the preclinical stage; in May 2024, the company received positive pre-IND feedback from the U.S. FDA, which confirmed the requirements for its clinical development plan and supported the use of the botanical drug pathway.

Other names: kudzu extract

Targets

ALDH2 (Mitochondrial Aldehyde Dehydrogenase)

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