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FNP-254
- Development stage
- Unknown
- Lead developer
- Ferrer
- Modality
- Small Molecules, Inhalation Devices → Device-based Delivery → Drug Delivery Systems
- 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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