Trial Profile

Phase 3 Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

Drugs Sodium dichloroacetate (Primary)
Indications Pyruvate dehydrogenase complex deficiency disease
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms DCA/PDCD

Most Recent Events

04 May 2025 Planned End Date changed from 30 Mar 2025 to 27 Aug 2025.
04 May 2025 Planned primary completion date changed from 30 Mar 2025 to 27 Aug 2025.
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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