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DT-168

Phase 2

Fuchs Endothelial Corneal Dystrophy | Small molecule | Ophthalmology |Design Therapeutics, Inc.|Trials Updated: Sep 28, 2026

DT-168 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2025

DT-168 target and mechanism

Molecular targetTCF4
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

DT-168 clinical trials

DT-168 · 1 trial · 2 indications

Phase 2 1
NCT07024693DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal DystrophyFuchs Endothelial Corneal Dystrophy
RECRUITING70 Analytics
PHASE2RECRUITING
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal DystrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

FECD Biomarkers: Splicing Panel
Perioperative

Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.

Secondary Endpoints

Safety and Tolerability
Through study completion, an average of 4 weeks.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALDrug: DT-168

Interventions

NameTypeDescription
DT-168DRUGActive
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study. * ≥30 years of age (inclusive). * Documented diagnosis of FECD in the study eligible eye. * Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele. * Ca...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMSep 28, 2026NCT07024693Enrollment: 28 → 70
MEDIUMSep 28, 2026NCT07024693Enrollment: 28 → 70

Frequently asked questions about DT-168

What is DT-168 used for?

DT-168 is an investigational small molecule being developed for Fuchs Endothelial Corneal Dystrophy, an eye condition affecting the cornea. It is in Phase 2 clinical development and is not yet approved for any use. The current study enrolls patients with Fuchs Endothelial Corneal Dystrophy who are undergoing keratoplasty.

What does DT-168 target?

DT-168 targets TCF4, a transcription factor. By acting on TCF4, the small molecule is designed to address the underlying cause of Fuchs Endothelial Corneal Dystrophy. This targeted approach distinguishes it from symptomatic treatments for the condition.

Who is developing DT-168?

DT-168 is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker DSGN. The company is focused on small molecule therapeutics for serious degenerative diseases, and DT-168 is its investigational candidate for Fuchs Endothelial Corneal Dystrophy.

What phase is DT-168 in?

DT-168 is in Phase 2 clinical development. The only trial listed is a Phase 2 study that is currently recruiting participants. There are no completed trials for DT-168, and the drug remains investigational.

What clinical trials is DT-168 in?

DT-168 is being evaluated in a single Phase 2 trial, NCT07024693, titled "DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy." The study is recruiting 70 participants in the United States. It is an uncontrolled trial, meaning it does not have a placebo or active comparator arm.