Praxis Precision Medicines’ Ulixacaltamide NDA Accepted, PDUFA Set for January 29, 2027
The FDA has accepted Praxis Precision Medicines’ New Drug Application for ulixacaltamide HCl to treat adult essential tremor, assigning a PDUFA action date of January 29, 2027 and forgoing an advisory committee meeting. The NDA is supported by positive Essential3 Phase 3 trial results and holds Breakthrough Therapy Designation.
1. FDA Acceptance of NDA
Praxis Precision Medicines received FDA acceptance of its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults, with a PDUFA target action date of January 29, 2027 and no advisory committee meeting planned.
2. Phase 3 Efficacy and Safety
The application is supported by the Essential3 program, comprising two pivotal Phase 3 studies that demonstrated statistically significant efficacy and a tolerability profile consistent with prior trials, with no drug-related serious adverse events reported.
3. Breakthrough Designation and Next Steps
Ulixacaltamide holds Breakthrough Therapy Designation from the FDA since December 2025, and Praxis is preparing for commercial launch while engaging with the FDA through the review process ahead of the PDUFA date.