Name: Ulixacaltamide in Essential tremor: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

5 evidence topics · 5 sources

Breakthrough Therapy Designation

Type of information	Source quotation
Special FDA designation: date	“December 29, 2025”
Special FDA designation	“Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor”

Regulatory submission: NDA submitted by February 2026

“February 19, 2026” (opens the source at this quote in a new tab)
“Praxis has submitted an NDA for the treatment of ET.” (opens the source at this quote in a new tab)

FDA target action date

“PDUFA target action date of January 29, 2027” (opens the source at this quote in a new tab)

Regulatory review and FDA Advisory Committee meeting

“August 6, 2026” (opens the source at this quote in a new tab)
“FDA identified no major safety or efficacy concerns to date.” (opens the source at this quote in a new tab)
“The agency confirmed that no advisory committee meeting is planned.” (opens the source at this quote in a new tab)

Investigational status

“Ulixacaltamide is investigational and has not been approved by the FDA.” (opens the source at this quote in a new tab)

Launch

No evidence found.

Approval dates in other countries

No evidence found.