Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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: 14 Jan 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

Most Recent Events

  • 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.
  • 04 Dec 2025 According to a Praxis Precision Medicines media release, the company announced the successful completion of its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting. The company has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.
  • 16 Oct 2025 According to Praxis Precision Medicines media release, Praxis has submitted a pre-NDA meeting request to the FDA with plans to submit the NDA by early 2026, upon agreement with the agency.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top