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An Open-label Phase 1/2/3 Study Consisting of a Phase 1/2 Safety and Dose-escalation and Phase 3 Dose-expansion Study to Evaluate Safety and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy in Females With Rett Syndrome

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Trial Profile

An Open-label Phase 1/2/3 Study Consisting of a Phase 1/2 Safety and Dose-escalation and Phase 3 Dose-expansion Study to Evaluate Safety and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy in Females With Rett Syndrome

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Mar 2026

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At a glance

  • Drugs TSHA 102 (Primary)
  • Indications Rett syndrome
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms REVEAL; REVEAL Adult Study
  • Sponsors Taysha Gene Therapies

Most Recent Events

  • 20 Mar 2026 According to a Taysha Gene Therapies media release, Completion of dosing in the REVEAL pivotal trial is expected in the second quarter of 2026. Update on longer-term safety and efficacy data from Part A of REVEAL Phase 1/2 trials expected in the second quarter of 2026.
  • 01 Jan 2026 According to a Taysha Gene Therapies media release, Completion of dosing in the this pivotal trial is expected in the second quarter of 2026 and longer-term safety and efficacy data from Part A of the REVEAL trial is expected in the first half of 2026.
  • 01 Jan 2026 According to a Taysha Gene Therapies media release, first patient has been dosed in this trial.

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