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DT-168

Phase 2

Fuchs Endothelial Corneal Dystrophy | Small molecule | Ophthalmology |Design Therapeutics, Inc.|Last Updated: Dec 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07024693DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal DystrophyPHASE2 RECRUITING 28Jul 30, 2025Dec 1, 2026Dec 29, 20252 United States
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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 — 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)
LOWMay 26, 2026NCT07024693primaryCompletionDate: changed
LOWMay 24, 2026NCT07024693studyFirstPostDate: changed