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

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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: 02 Jul 2025

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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

  • 19 Jun 2025 According to a Saol Therapeutics media release, Dr. Peter Stacpoole, and the other investigators plan to submit the results of the Phase III clinical program for publication.
  • 19 Jun 2025 According to a Saol Therapeutics media release, key data from this study were presented as a poster by Dr. Peter Stacpoole at the Mitochondrial Medicine 2025 conference in St. Louis.
  • 17 Apr 2025 According to a Saol Therapeutics media release, The FDA recently notified Saol of a 90-day extension to the NDA review, moving the PDUFA date from May 27, 2025, to August 27, 2025. No concerns were raised by the FDA about the adequacy of the filing or the need for an advisory committee meeting.

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