IND-Cleared CNS Therapeutic Asset
Targeting ADHD and Alzheimer's Apathy
PRX-P4-003 is a novel oral prodrug stimulant advancing development across ADHD, apathy in Alzheimer's Disease, apathy in Frontotemporal Dementia, and post-TBI deficits.
FDA IND Cleared | Phase 1 Ready | Patent Protection Expected into the Early 2040s
Lead Program Snapshot
Program: PRX-P4-003
Stage: FDA IND Cleared / Phase 1 Ready
Indications: ADHD, Alzheimer's apathy, FTD apathy, and traumatic brain injury
PRX-P4-003 is a gut-activated prodrug designed to deliver the active isomer of fencamfamine with balanced dopamine pharmacology and built-in abuse deterrence.
- Potential Schedule IV stimulant alternative
- Gut-activated prodrug mechanism with abuse-deterrent potential
- Once-daily dosing with approximately 15-hour duration
- Composition-of-matter patent protection expected into the early 2040s, including potential PTE
- Developed entirely in-house from discovery through IND clearance
PRX-P4-003 activation mechanism
Strategic Overview
PRX-P4-003 is being advanced for large CNS markets with significant unmet need.
- 144-160M children with ADHD worldwide
- 201.5M adults affected by ADHD globally
- No FDA-approved therapy currently exists for Alzheimer's apathy
Praxis Bioresearch is seeking strategic partners to accelerate the clinical development of PRX-P4-003.
- Co-development partnerships for CNS indications
- Regional licensing opportunities
- Qualified diligence access to the VDR and IND package materials
High-value validation signals support near-term clinical advancement.
- FDA IND clearance for PRX-P4-003
- Human microdose PK validation
- GMP drug product available for clinical trials
- Granted Composition of Matter patent protection in major markets, including the U.S., Europe, China, and Japan
Led by Experienced Leadership
Our team brings decades of combined experience in neuroscience, drug development, and clinical research.
With additional guidance from leading experts including Prof. Valentino Stella (Inventor and Prodrug Expert) and Adam Levy (Director, CFO of Mineralys).
Forward-Looking Statements
This website may contain forward-looking statements regarding Praxis Bioresearch's research, development plans, and business strategy. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Scientific visualizations, animations, and molecular or graphical illustrations on this website are simplified representations intended for educational and illustrative purposes. Praxis Bioresearch undertakes no obligation to update forward-looking statements except as required by law.