Praxis Bioresearch
Clinical-stage biopharmaceutical company focused on discovery and development of gut-activated prodrug stimulants for CNS indications. Lead candidate is a Phase 1–ready oral prodrug designed to deliver an active isomer of a dopamine/norepinephrine modulator with a gut-specific activation mechanism, GMP clinical supply, IND clearance, and patent protection expected into the early 2040s.
Industries
Nr. of Employees
small (1-50)
Praxis Bioresearch
Patents
Products
PRX-P4-003 (oral gut-activated prodrug stimulant)
New chemical entity prodrug designed for oral activation by pancreatic lipase to release an active isomer with balanced dopamine/norepinephrine pharmacology, developed for ADHD, apathy in Alzheimer's and Frontotemporal Dementia, and post-TBI deficits. IND cleared and Phase 1–ready with GMP drug product available and patent protection expected into the early 2040s.
PRX-P4-003
PRX-P4-003 is a clinical-stage new chemical entity and Phase 1-ready CNS stimulant candidate combining structural novelty with the de-risking benefit of the active isomer of fencamfamine, designed for once-daily dosing and built-in abuse deterrence.
PRX-P4-003 (oral gut-activated prodrug stimulant)
New chemical entity prodrug designed for oral activation by pancreatic lipase to release an active isomer with balanced dopamine/norepinephrine pharmacology, developed for ADHD, apathy in Alzheimer's and Frontotemporal Dementia, and post-TBI deficits. IND cleared and Phase 1–ready with GMP drug product available and patent protection expected into the early 2040s.
PRX-P4-003
PRX-P4-003 is a clinical-stage new chemical entity and Phase 1-ready CNS stimulant candidate combining structural novelty with the de-risking benefit of the active isomer of fencamfamine, designed for once-daily dosing and built-in abuse deterrence.
Services
Provision of VDR access, IND package summaries, and executive technical briefings to qualified partners for co-development and regional licensing.
Provision of VDR access, IND package summaries, and executive technical briefings to qualified partners for co-development and regional licensing.
Expertise Areas
- CNS drug discovery and development
- Prodrug design and gut-specific enzymatic activation
- Preclinical abuse-liability evaluation
- Early-phase clinical pharmacokinetics (microdose/Phase 0)
Key Technologies
- Gut-activated prodrug design
- Pancreatic lipase-mediated prodrug activation
- Dopamine and norepinephrine transporter modulation
- Microdose clinical pharmacokinetic studies
News & Updates
FDA cleared the Investigational New Drug (IND) application for the lead prodrug stimulant candidate, allowing clinical trials to proceed for apathy in Alzheimer's Disease.
Presentation of Phase 0 microdose human PK data demonstrating oral activation and pharmacokinetic profile supporting once-daily dosing.
Received a Fast-Track SBIR grant to support development for apathy in Alzheimer's Disease including Phase 0/Phase 1 studies and IND-enabling work.
Announced positive Phase 0 microdose study results in humans showing effective conversion of the prodrug to its active metabolite.
Issuance of U.S. Patent No. 10,683,276 covering composition, formulations, and methods of use for the prodrug stimulant.
Received an SBIR grant to support preclinical and early clinical development focusing on abuse-deterrent properties.
FDA cleared the Investigational New Drug (IND) application for the lead prodrug stimulant candidate, allowing clinical trials to proceed for apathy in Alzheimer's Disease.
Presentation of Phase 0 microdose human PK data demonstrating oral activation and pharmacokinetic profile supporting once-daily dosing.
Received a Fast-Track SBIR grant to support development for apathy in Alzheimer's Disease including Phase 0/Phase 1 studies and IND-enabling work.
Announced positive Phase 0 microdose study results in humans showing effective conversion of the prodrug to its active metabolite.
Issuance of U.S. Patent No. 10,683,276 covering composition, formulations, and methods of use for the prodrug stimulant.
Received an SBIR grant to support preclinical and early clinical development focusing on abuse-deterrent properties.