fencamfamine prodrug (PRX-P4-003)
/ Praxis Bioresearch
- LARVOL DELTA
Home
Next
Prev
1 to 6
Of
6
Go to page
1
October 29, 2024
Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy
(GlobeNewswire)
- "Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease."
IND • Alzheimer's Disease • CNS Disorders
August 07, 2021
[VIRTUAL] Microdose Study of a Novel Psychostimulant Prodrug, PRX-P4-003, with Reduced Abuse Liability for Apathy in AD
(CTAD 2021)
- "PRX-P4-003 is converted in humans to pharmacologically active (-)-FCF which is detected in plasma consistent with predictions from preclinical studies. The finding of a much earlier peak concentration in the fed state is consistent with the postulated dependence of release of pancreatic lipases into the gut following ingestion of food. The properties of PRX-P4-003 shown in this microdose study support its further development for the treatment of apathy in AD as a drug with at least equivalent efficacy to methylphenidate and a lower liability of abuse or diversion."
November 10, 2021
Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
(clinicaltrials.gov)
- P1; N=6; Completed; Sponsor: Praxis Bioresearch, LLC; Active, not recruiting ➔ Completed
Clinical • Trial completion
November 09, 2021
Praxis Bioresearch Presents Phase 0 Clinical Data for PRX-P4-003 at 14th Annual CTAD conference
(GlobeNewswire)
- "Praxis Bioresearch reports Clinical Phase 0 study data (PBR001) to demonstrate the desired pharmacokinetic profile for its lead product candidate, PRX-P4-003 in healthy volunteers (NCT04638803)....The PBR001 data are being reported in a virtual poster presentation format at the 14th Clinical Trials on Alzheimer's Disease (CTAD) meeting, being held November 9-12, in Boston, MA."
Clinical data • Alzheimer's Disease • CNS Disorders
October 28, 2021
Praxis Bioresearch Seeks Regulatory Strategy Support from MMS Holdings to Develop Therapeutics for Alzheimer’s Disease
(Businesswire)
- “MMS Holdings (MMS)…provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate, PRX-P4-003….With the positive clinical data from the Phase 0 program and funding of the Fast-Track SBIR Grant, Praxis can now advance PRX-P4-003 to early clinical development.”
Financing • Licensing / partnership • Alzheimer's Disease • CNS Disorders
September 16, 2021
Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
(clinicaltrials.gov)
- P1; N=8; Active, not recruiting; Sponsor: Praxis Bioresearch, LLC; Recruiting ➔ Active, not recruiting; Trial primary completion date: Jun 2021 ➔ Oct 2021
Clinical • Enrollment closed • Trial primary completion date
1 to 6
Of
6
Go to page
1