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Praxis Precision Medicines (PRAX) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
40 Mg/Day Vormatrogine For 12 Weeks, 30 Mg/Day Vormatrogine For 12 Weeks, 20 Mg/Day Vormatrogine For 12 WeeksFocal EpilepsyPhase IIIActive Not RecruitingRandomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal SeizuresMar 26, 2026―
VormatrogineEpilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized SeizurePhase IIIEnrolling By InvitationClinical Trial of Vormatrigine in Adult Patients With EpilepsyDec 11, 2025―
Sham Procedure, 1Mg Elsunersen, 0.5Mg ElsunersenScn2a Encephalopathy, Epileptic EncephalopathyPhase IIIRecruitingA Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and SafetyJun 05, 2025
1.0Mg/Kg/Day Prax-562, 1.5Mg/Kg/Day Prax-562Developmental And Epileptic Encephalopathy 1Phase IIIRecruitingA Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of RelutrigineMay 30, 2025
30Mg Prax-628Focal Onset Seizure, Primary Generalized EpilepsyPhase IIRecruitingAn Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic SeizuresMar 19, 2025
20Mg/Day Prax-628 For 6 Weeks Then 30Mg/Day Prax-628 For Remaining 6 WeeksFocal Seizurephase2AndPhase3RecruitingDouble-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)Mar 14, 2025
Prax-628HealthyPhase ICompletedA Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628Jan 29, 2025
60 Mg UlixacaltamideEssential TremorPhase IIIActive Not RecruitingEssential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)Oct 12, 2023
Prax-562Scn2a Encephalopathy, Scn8a Encephalopathyphase2AndPhase3Active Not RecruitingA Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)Mar 17, 2023
Prax-222 - Initial Dose, Prax-222 - Initial Ascending Doses, Prax-222 - Optional Ascending Doses, Prax-222 - Fixed DosesEpilepsy, Scn2a-Deephase1AndPhase2Active Not RecruitingA Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic EncephalopathyFeb 10, 2023

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
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, Inc. (PRAX) have in its pipeline
Praxis Precision Medicines PRAX is currently developing the following drugs: 40 Mg/Day Vormatrogine For 12 Weeks, 30 Mg/Day Vormatrogine For 12 Weeks, 20 Mg/Day Vormatrogine For 12 Weeks, Vormatrogine, Sham Procedure, 1Mg Elsunersen, 0.5Mg Elsunersen, 1.0Mg/Kg/Day Prax-562, 1.5Mg/Kg/Day Prax-562, 30Mg Prax-628, 20Mg/Day Prax-628 For 6 Weeks Then 30Mg/Day Prax-628 For Remaining 6 Weeks, Prax-628, 60 Mg Ulixacaltamide, Prax-562, Prax-222 - Initial Dose, Prax-222 - Initial Ascending Doses, Prax-222 - Optional Ascending Doses, Prax-222 - Fixed Doses. These drug candidates are in various stages of clinical development as the company works toward FDA approval.