Trial Profile

ASPIRE Study: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy, for the Treatment of Pediatric Females Aged >2 to <4 Years With Rett Syndrome

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 May 2026

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At a glance

22 May 2026 Status changed from not yet recruiting to recruiting.
06 May 2026 According to a Taysha Gene Therapies media release, ASPIRE safety-focused trial is designed to support a planned BLA submission to enable broad labeling of TSHA-102 for patients aged greater and equal to 2 years with Rett syndrome.
06 May 2026 According to a Taysha Gene Therapies media release, completion of dosing in the ASPIRE trial is expected in the second quarter of 2026

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