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Dichloroacetate - Saol therapeutics

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Drug Profile

Dichloroacetate - Saol therapeutics

Alternative Names: Dichloroacetate sodium; SIL-1009; SL-1009; Sodium Dichloroacetate- DCA

Latest Information Update: 24 Jun 2025

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At a glance

  • Originator Saol Therapeutics
  • Developer Food and Drug Administration; National Institute of Child Health and Human Development; Saol Therapeutics; University of Florida
  • Class Acetates; Antineoplastics; Neuroprotectants; Nootropics; Small molecules
  • Mechanism of Action Pyruvate dehydrogenase complex stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Metabolic disorders
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Pyruvate dehydrogenase complex deficiency disease
  • Phase III Metabolic disorders

Most Recent Events

  • 19 Jun 2025 Efficacy and safety data from a phase III trial in Pyruvate-dehydrogenase-complex-deficiency-disease released by Saol Therapeutics
  • 17 Apr 2025 Saol is preparing for a Type C meeting with the FDA to discuss the clinical development program for the use of DCA in the treatment of congenital lactic acidosis
  • 17 Apr 2025 US FDA assigns PDUFA action date of (27/08/2025) for Dichloroacetate for Pyruvate dehydrogenase complex deficiency disease

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