Drug Profile

TSHA 102

Alternative Names: TGTX 104; TSHA-102

Latest Information Update: 25 Aug 2025

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At a glance

Originator University of Texas Southwestern Medical Center
Developer Taysha Gene Therapies
Class Gene therapies
Mechanism of Action Gene transference; Methyl-CpG-binding protein 2 gene replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Rett syndrome
New Molecular Entity No

Highest Development Phases

Phase I/II Rett syndrome

Most Recent Events

12 Aug 2025 Taysha Gene Therapies receives No Objection Letter from Health Canada for TSHA 102
12 Aug 2025 Taysha Gene Therapies submits Clinical Trial Application Amendment (CTA-A) to Health Canada for phase I/II REVEAL trial
12 Aug 2025 Taysha Gene Therapies submits IND application amendment to US FDA for phase I/II REVEAL trial

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