Taysha Gene Therapies

Taysha Gene Therapies works on 3 rare diseases tracked on Trial Friend, including Leigh Syndrome, Rett Syndrome, Tay-Sachs Disease, with 4 recruiting clinical trials.

Taysha Gene Therapies is a clinical-stage biotechnology company developing AAV-based gene therapies for rare monogenic diseases of the central nervous system. The company is focused on TSHA-102 for Rett syndrome, its lead program now in a pivotal trial. Taysha previously had programs for giant axonal neuropathy and CLN1 Batten disease but has deprioritized these to concentrate resources on Rett.

Type
Rare Disease Specialist
Ticker
TSHA
Headquarters
Dallas, United States
Founded
2019
4
Active Rare Disease Trials
3
Rare Diseases in Portfolio
7
Years Active

Focus areas at Taysha Gene Therapies

As a rare disease specialist, Taysha Gene Therapies has active clinical trial programs and drug development efforts across 3 rare diseases, including Leigh Syndrome, Rett Syndrome, Tay-Sachs Disease. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows all active and recruiting studies sponsored by Taysha Gene Therapies, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites. The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Taysha Gene Therapies is headquartered in Dallas, United States, founded in 2019, publicly traded under the ticker symbol TSHA. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Taysha Gene Therapies Drug Pipeline

Taysha Gene Therapies has 4 active clinical trials across 2 development stages, with 4 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Taysha Gene Therapies's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Taysha Gene Therapies's pipeline
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
2
Phase 22 trials
2
Phase 32 trials
Recruiting
Recruiting

Taysha Gene Therapies Clinical Trials (4)

Active and recruiting clinical trials sponsored by Taysha Gene Therapies, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Taysha Gene Therapies's trials
Type your own question with a little about your situation, and get an answer with sources.
Tap to start:
Or start with one of these
ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT07480564

Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome

Intervention: TSHA-102

The primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.

Ages 2 Years - 3 Years3 locations
View full study
ACTIVE NOT RECRUITINGPHASE3Recently updatedNCT05606614

A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)

Intervention: TSHA-102

The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the efficacy and safety of TSHA-102 at the selected dose.

Ages 6 Years - 21 Years9 locations
View full study
ACTIVE NOT RECRUITINGPHASE1, PHASE2No updates in a whileNCT06152237

Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study)

Intervention: TSHA-102

The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.

Ages 5 Years - 8 Years5 locations
View full study
ACTIVE NOT RECRUITINGPHASE1, PHASE2Hasn't posted an update in over a yearNCT04798235

First-in-Human Study of TSHA-101 Gene Therapy for Treatment of Infantile Onset GM2 Gangliosidosis

Intervention: TSHA-101

GM2 gangliosidoses are a group of autosomal recessive neurodegenerative diseases characterized by a deficiency of the Hex A enzyme to catabolize GM2, thereby causing GM2 accumulation within cellular lysosomes.Hex A is composed of 2 subunits, α- and β-, coded by the HEXA and HEXB genes, respectively. The primary purpose of the current study is to assess the safety and tolerability of TSHA101 administered via IT injection.

Ages Up to 15 Months1 location
View full study

FDA-Approved Drugs

No FDA-approved drugs found for this company at this time.

Taysha Gene Therapies Trial Locations

Taysha Gene Therapies clinical trials are running at 18 sites in 3 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
14▼
Canada
3▼
United Kingdom
1▼

Rare Disease Focus Areas (3)

Diseases targeted by Taysha Gene Therapies's clinical trial and drug development programs

Patient Resources

Organizations and resources related to Taysha Gene Therapies's rare disease focus areas

Frequently Asked Questions About Taysha Gene Therapies

Common questions about Taysha Gene Therapies's rare disease programs, clinical trials, and treatments.