Rett Syndrome

Rare Diseases
13
Pipeline Programs
5
Companies
11
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
2
2
6
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
4100%
+ 7 programs with unclassified modality

On Market (2)

Approved therapies currently available

Acadia Pharmaceuticals
DAYBUEApproved
trofinetide
Acadia Pharmaceuticals
oral2023
Acadia Pharmaceuticals
DAYBUE STIXApproved
trofinetide
Acadia Pharmaceuticals
oral2025

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Acadia Pharmaceuticals
4 programs
1
3
1
TrofinetidePhase 3Peptide1 trial
TrofinetidePhase 3Peptide1 trial
trofinetidePhase 3Peptide1 trial
TrofinetidePhase 2/3Peptide1 trial
Active Trials
NCT04988867Terminated15Est. May 2023
NCT04181723Completed187Est. Oct 2021
NCT04279314Completed154Est. Aug 2022
+1 more trials
Taysha Gene Therapies
2 programs
1
1
TSHA-102Phase 31 trial
TSHA-102Phase 1/21 trial
Active Trials
NCT06152237Active Not RecruitingEst. Nov 2031
NCT05606614RecruitingEst. Jun 2031
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
2
GWP42003-PPhase 31 trial
GWP42003-PPhase 31 trial
Active Trials
NCT04252586Terminated21Est. Jun 2021
NCT03848832Terminated29Est. Jan 2021
Newron Pharmaceuticals
1 program
1
Sarizotan low dosePhase 2/31 trial
Active Trials
NCT02790034TerminatedEst. May 2020
Ultragenyx Pharmaceutical
2 programs
2
Tridecanoic AcidPhase 21 trial
triheptanoinPhase 21 trial
Active Trials
NCT03059160Unknown10Est. Aug 2018
NCT02696044Unknown12Est. Feb 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Taysha Gene TherapiesTSHA-102
Acadia Pharmaceuticalstrofinetide
Jazz PharmaceuticalsGWP42003-P
Acadia PharmaceuticalsTrofinetide
Acadia PharmaceuticalsTrofinetide
Jazz PharmaceuticalsGWP42003-P
Acadia PharmaceuticalsTrofinetide
Newron PharmaceuticalsSarizotan low dose
Ultragenyx PharmaceuticalTridecanoic Acid
Ultragenyx Pharmaceuticaltriheptanoin
Taysha Gene TherapiesTSHA-102

Clinical Trials (11)

Total enrollment: 505 patients across 11 trials

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

Start: Mar 2023Est. completion: Jun 2031
Phase 3Recruiting

Open-Label Extension Study of Trofinetide for Rett Syndrome

Start: Nov 2020Est. completion: Jun 202377 patients
Phase 3Terminated

A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome

Start: Feb 2020Est. completion: Jun 202121 patients
Phase 3Terminated

Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

Start: Jan 2020Est. completion: Aug 2022154 patients
Phase 3Completed

Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)

Start: Nov 2019Est. completion: Oct 2021187 patients
Phase 3Completed

Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome

Start: Jul 2019Est. completion: Jan 202129 patients
Phase 3Terminated

An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome

Start: Sep 2021Est. completion: May 202315 patients
Phase 2/3Terminated

Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms

Start: Oct 2016Est. completion: May 2020
Phase 2/3Terminated

Open Label Trial of Triheptanoin (UX007) in Treatment of Rett Syndrome.

Start: Apr 2017Est. completion: Aug 201810 patients
Phase 2Unknown

Treatment of Mitochondrial Dysfunction in Rett Syndrome With Triheptanoin

Start: Jun 2016Est. completion: Feb 202212 patients
Phase 2Unknown

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

Start: Dec 2023Est. completion: Nov 2031
Phase 1/2Active Not Recruiting

Related Jobs in Rare Diseases

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 505 patients
5 companies competing in this space