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SGT-501 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (≥ 18 years of age) | EXPERIMENTAL | Participants will receive a single intravenous (IV) infusion (dose 1) of SGT-501. |
| Cohort 2 (≥ 18 years of age) | EXPERIMENTAL | Participants will receive a single IV infusion (dose 2) of SGT-501. |
| Cohort 3 (≥ 7 to < 18 years) | EXPERIMENTAL | Participants will receive a single IV infusion (level at or below dose(s) assessed in adults) of SGT-501. |
| Name | Type | Description |
|---|---|---|
| SGT-501 | DRUG | IV for infusion |
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...
SGT-501 is an investigational small molecule being developed for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), a rare inherited heart rhythm disorder. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in a clinical trial enrolling patients aged 7 years and older.
SGT-501 is being developed by Solid Biosciences Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLDB. The company is conducting a Phase 1 clinical trial of SGT-501 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) in the United States and Canada.
SGT-501 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions with unmet medical needs.
SGT-501 is being evaluated in a Phase 1 clinical trial with the identifier NCT07148089, titled 'A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)'. The trial is currently recruiting participants and aims to enroll 18 patients in the United States and Canada.
No, SGT-501 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The FDA has granted Fast Track designation to SGT-501, which is a status that facilitates the development and review process for serious conditions.