Praxis Advances Ulixacaltamide With FDA Review For Essential Tremor Treatment

Praxis Precision Medicines has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 29, 2027, and currently does not plan to convene an advisory committee meeting for the review.

The NDA submission is supported by positive data from the Essential3 Phase 3 clinical program, which included two pivotal studies conducted simultaneously in adult patients with essential tremor. The trials demonstrated statistically and clinically meaningful improvements, forming the primary basis for the drug’s efficacy profile.

“Today’s announcement brings us one step closer to delivering something patients living with essential tremor have been waiting for, a therapy developed specifically for their condition,” said Marcio Souza, president and chief executive officer. “We look forward to continuing to work with the FDA through the review process while we prepare for the commercial launch.”

Ulixacaltamide showed a favorable safety and tolerability profile, consistent with earlier studies, with no drug-related serious adverse events reported. These findings reinforce its potential as a new treatment option for patients living with essential tremor, a condition with limited effective therapies.

The therapy had previously received Breakthrough Therapy Designation from the FDA in December 2025, highlighting its potential to address a significant unmet medical need. If approved, ulixacaltamide could represent an important advancement in the management of essential tremor.