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SGT-501

Phase 1

Catecholaminergic Polymorphic Ventricular Tachycardia | Small molecule | Other |Solid Biosciences Inc.|Last Updated: Jun 2, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07148089A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)PHASE1 RECRUITING 18Feb 23, 2026May 1, 2031Jun 2, 20265 United States, Canada
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Event (TEAEs)s through Day 360
First dose through Day 360
Secondary Endpoints
Change from baseline in ventricular arrhythmia score (VAS) on exercise stress test (EST) at Day 180
Baseline, Day 180
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 (≥ 18 years of age)EXPERIMENTALParticipants will receive a single intravenous (IV) infusion (dose 1) of SGT-501.
Cohort 2 (≥ 18 years of age)EXPERIMENTALParticipants will receive a single IV infusion (dose 2) of SGT-501.
Cohort 3 (≥ 7 to < 18 years)EXPERIMENTALParticipants will receive a single IV infusion (level at or below dose(s) assessed in adults) of SGT-501.
Interventions
NameTypeDescription
SGT-501DRUGIV for infusion
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Eligibility Criteria
Age Range7 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Type of Participant and Disease Characteristics: * Clinical diagnosis of CPVT, based on documented history of polymorphic or bidirectional non-sustained ventricular tachycardia with exercise or ventricular ectopy in a pattern consistent with CPVT on EST. * Central Screening lab...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT07148089lastUpdatePostDate: changed
LOWJun 2, 2026NCT07148089lastUpdatePostDate: changed
LOWJun 2, 2026NCT07148089lastUpdatePostDate: changed
LOWMay 26, 2026NCT07148089primaryCompletionDate: changed
LOWMay 24, 2026NCT07148089studyFirstPostDate: changed