Clinical Pipeline
Advancing innovative therapies through clinical development
PRX-P4-003 Clinical Development Program
Building on the solid scientific foundation detailed in our Discovery & Science section, we are advancing PRX-P4-003 through a strategic clinical development pathway for multiple indications with significant unmet needs. Our clinical program is designed to efficiently generate the data needed for regulatory approval while addressing key questions about safety, efficacy, and optimal dosing.
Recent Milestones
- IND CLEARED by FDA recently for initiating Phase 1 Studies
- GMP API and drug product successfully developed and available for Phase 1 and Phase 2 clinical testing
- SUCCESSFUL microdose PK study in HUMANS
Development Impact Highlights
PRX-P4-003 aims to address significant unmet needs affecting millions of patients worldwide. With approximately 70% of current ADHD treatments being stimulant-based, our innovative approach focuses on improving patient access and outcomes through potential Schedule IV classification. Our development pipeline prioritizes patient safety and treatment accessibility, particularly targeting the challenges faced by the estimated 379 million individuals affected globally, including 144-160 million children and 201.5 million adults with ADHD, along with 22-34 million Alzheimer's Disease patients experiencing apathy.
Sources: Global ADHD prevalence based on WHO and CDC data; Apathy in AD statistics from Alzheimer's Association and clinical studies.
Competitive Advantages
PRX-P4-003 offers several key advantages over existing therapies:
Schedule IV Stimulant Potential
PRX-P4-003 is based on fencamfamine, an established Schedule IV stimulant, and has been additionally protected against abuse by restricting its activation only by the oral route, thereby reducing abuse potential. This could position it as the first Schedule IV stimulant for ADHD, offering improved safety, efficacy and easier access than current Schedule II stimulants.
Balanced Mechanism
Unique profile between amphetamine and methylphenidate may provide effective symptom control with potentially improved side effect profile. For more details on the scientific foundations and mechanisms of action, visit our Discovery & Science page.
Built-in Abuse Deterrence
Gut-specific activation mechanism prevents misuse through intranasal or injection routes, potentially qualifying for Schedule IV classification.
Established Safety Foundation
Based on fencamfamine, which has a history of well-tolerated clinical use over several decades.
Full In-House Development
Developed entirely in-house from discovery through clinical stages, providing complete IP ownership, deep scientific insight, and full strategic control over development and commercialization.
Once-Daily Dosing
Extended duration of action (approximately 15 hours) enables convenient once-a-day therapy.