Drug intelligence / Profile preview

FNP-254

Development stage
Unknown
Lead developer
Ferrer
Modality
Inhalation Devices → Device-based Delivery → Drug Delivery Systems, Small Molecules
Administration
Inhalation
01

Overview

FNP-254 is an investigational drug-device combination product consisting of an inhaled formulation of pridopidine delivered via the proprietary Staccato technology. Developed through a collaboration between Alexza Pharmaceuticals (a Ferrer subsidiary) and Prilenia Therapeutics, FNP-254 is currently in Phase 2 clinical development for the treatment of Amyotrophic Lateral Sclerosis (ALS). The Staccato platform utilizes a hand-held inhaler that generates a high-purity drug aerosol through rapid thermal vaporization, allowing for deep lung penetration and rapid systemic absorption comparable to intravenous administration. Pridopidine, the active pharmaceutical ingredient, is a highly selective Sigma-1 receptor (S1R) agonist. By activating S1R, pridopidine aims to restore cellular homeostasis and provide neuroprotection by modulating calcium signaling, enhancing mitochondrial function, and reducing endoplasmic reticulum stress in motor neurons.

Other names
Staccato pridopidine
02

Targets

SIGMAR1 (Sigma non-opioid intracellular receptor 1)

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