PRX-P4-003

PRX-P4-003 is a novel oral prodrug designed to selectively deliver (-)-fencamfamine, the active isomer of fencamfamine—a well-tolerated Schedule IV stimulant with a long-established clinical profile in Europe and other regions[6][7][8]. Developed by Praxis Bioresearch as a new chemical entity (NCE), PRX-P4-003 is activated specifically in the gut by pancreatic lipase, resulting in selective oral bioavailability and limiting its stimulant activity to oral administration[1][2][5]. This mechanism provides built-in abuse deterrence since parenteral routes do not activate the drug. Mechanistically, PRX-P4-003 acts as a dopamine and norepinephrine reuptake inhibitor with mild dopamine release properties but no monoamine oxidase inhibition[1][8]. The primary indications under development are apathy in Alzheimer’s disease—where there are currently no FDA-approved therapies—and attention-deficit/hyperactivity disorder (ADHD)[7][8]. The compound offers once-daily dosing convenience and aims to provide improved safety and efficacy compared to current Schedule II stimulants.

Other names

octadecanoic acid, [[[ethyl[(1R,2R,3S,4S)-3-phenylbicyclo[2.2.1]hept-2-yl]amino]carbonyl]oxy]methyl ester