Drugs

Ulixacaltamide

Ulixacaltamide is an oral T-type calcium channel inhibitor developed by Praxis Precision Medicines for essential tremor. The next event is the FDA decision on Ulixacaltamide, on Jan 29, 2027 (source).

Company
How it works
T-type calcium channel inhibitor
Approved
Not approved in any market we track

Development by disease

Essential tremorFiled

Upcoming events

Firm dates · a specific day set by the company or regulator

Past results and milestones

  • Feb 19, 2026
    reported
    The NDA for ulixacaltamide HCl in essential tremor was submitted to the FDA following a positive pre-NDA meeting in December 2025 and positive Phase 3 ESSENTIAL3 results announced in October 2025. Source
  • Dec 29, 2025
    FDA granted Breakthrough Therapy Designation for ulixacaltamide in essential tremor based on positive topline data from the Essential3 Phase 3 pivotal studies program. Source
  • Nov 5, 2025
    Both Essential3 studies met their primary endpoints. Study 1 (placebo-controlled) demonstrated 4.3-point mADL11 improvement at Week 8 (p=0.0001) with all secondary endpoints met. Study 2 (randomized withdrawal) showed 55% response maintenance on ulixacaltamide vs 33% placebo (p=0.037). Source
  • Oct 16, 2025
    Both Essential3 Study 1 (parallel-group) and Study 2 (randomized withdrawal) met their primary and key secondary endpoints. Study 1 demonstrated mADL11 improvement of -4.3 vs -1.7 placebo (p=0.0001) at Day 56; Study 2 showed 55% vs 33% response maintenance (p=0.037). No drug-related serious adverse events reported. Source

Trials

ESSENTIAL3
The investment thesis, what each upcoming event depends on and the competitive landscape are on the Praxis Precision Medicines page. Upcoming FDA decisions · All drugs