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Praxis Precision Medicines (PRAX)
NASDAQ:PRAX
Sham Procedure, 1Mg Elsunersen, 0.5Mg Elsunersen
Scn2a Encephalopathy, Epileptic Encephalopathy
Phase III
Recruiting
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
Jun 05, 2025
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1.0Mg/Kg/Day Prax-562, 1.5Mg/Kg/Day Prax-562
Developmental And Epileptic Encephalopathy 1
Phase III
Recruiting
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
May 30, 2025
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30Mg Prax-628
Focal Onset Seizure, Primary Generalized Epilepsy
Phase II
Recruiting
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Mar 19, 2025
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20Mg/Day Prax-628 For 6 Weeks Then 30Mg/Day Prax-628 For Remaining 6 Weeks
Focal Seizure
Phase II/III
Recruiting
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
Mar 14, 2025
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Prax-628
Healthy
Phase I
Not Yet Recruiting
A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628
Jan 29, 2025
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60 Mg Ulixacaltamide
Essential Tremor
Phase III
Enrolling By Invitation
Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)
Oct 12, 2023
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Prax-562
Scn2a Encephalopathy, Scn8a Encephalopathy
Phase II/III
Recruiting
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
Mar 17, 2023
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Prax-222 - Initial Dose, Prax-222 - Initial Ascending Doses, Prax-222 - Optional Ascending Doses, Prax-222 - Fixed Doses
Epilepsy, Scn2a-Dee
Phase I/II
Recruiting
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
Feb 10, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Praxis Precision Medicines (PRAX) have in its pipeline
PRAX is currently developing the following drugs: Sham Procedure, 1Mg Elsunersen, 0.5Mg Elsunersen, 1.0Mg/Kg/Day Prax-562, 1.5Mg/Kg/Day Prax-562, 30Mg Prax-628. These drug candidates are in various stages of clinical development as the company works toward FDA approval.