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Trial Profile

A SL1009-02 survival analysis study comparing outcomes for DCA-treated patients in the Phase III study

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 10 Dec 2024

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At a glance

Drugs Sodium dichloroacetate (Primary)
Indications Pyruvate dehydrogenase complex deficiency disease
Focus Registrational; Therapeutic Use
Sponsors Saol Therapeutics

Most Recent Events

10 Dec 2024 New trial record
03 Dec 2024 According to a Saol Therapeutics media release, company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of SL1009 for the treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD) supported by results from the Phase 3 double-blind placebo controlled cross-over study (SL1009-01) and a survival study (SL1009-02).

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