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SL1009 (sodium dichloroacetate)

Pyruvate dehydrogenase complex deficiency

Manufacturer
Saol Therapeutics
Regulatory submission
NDA resubmitted June 2026
Launch
Not announced
Last updated
78 sources

Product information and disease descriptionProduct descriptionProduct information

Contraindications/Warnings/Precautions/Adverse effects

4 evidence topics · 2 sources

Warnings and precautions
Investigational treatment: clinically limiting toxicity

“The main clinically limiting toxicity is reversible peripheral neuropathy.” (opens the source at this quote in a new tab)

Chronic exposure: sensory and motor neuropathy

“A reversible sensory/motor peripheral neuropathy is the clinically limiting adverse effect of chronic DCA exposure” (opens the source at this quote in a new tab)

Neuropathy character, dose dependence, and time to resolution

“DCA therefore appears to induce a dose-dependent, largely reversible, distal peripheral neuropathy that afflicts large and small fibers of motor and sensory nerves and causes both sensory loss and pain.” (opens the source at this quote in a new tab)

“In all studies, peripheral neuropathy generally resolved over 6–18 months following dose de-escalation or discontinuation, although in some cases it persisted.” (opens the source at this quote in a new tab)

Neuropathy risk by age

“Clinical descriptions of DCA-induced peripheral neuropathy have emphasized that it is more common and severe in adults than children” (opens the source at this quote in a new tab)

“In liver, cytosolic GSTZ1 expression (the dominant cellular fraction) reaches adult levels at around 7 years of age, while the mitochondrial form only reaches maximal expression and activity at around 21 years of age” (opens the source at this quote in a new tab)

“This explanation is supported by the finding that DCA clearance is reduced less in children than adults following 6 months DCA treatment” (opens the source at this quote in a new tab)