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Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor

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Trial Profile

Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2026

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At a glance

  • Drugs Ulixacaltamide (Primary)
  • Indications Essential tremor
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Essential3
  • Sponsors Praxis Precision Medicines

Most Recent Events

  • 14 Apr 2026 According to a Praxis Precision Medicines media release, based on the data from the trial, the U.S. FDA has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027 and is not planning to hold an advisory committee meeting.
  • 13 Apr 2026 According to a Praxis Precision Medicines media release, data from the trial will be presented at the 2026 AAN Annual Meeting, taking place April 18-22, 2026, in Chicago, Illinois.
  • 29 Dec 2025 According to a Praxis Precision Medicines media release, based on results from the Essential3 program, company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ulixacaltamide, for the treatment of patients with essential tremor.

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