Saol Therapeutics has resubmitted its New Drug Application (NDA) to FDA for SL1009 (sodium dichloroacetate) as a treatment for pyruvate dehydrogenase complex deficiency (PDCD), a rare mitochondrial disorder with no approved therapies.
The resubmission follows a Complete Response Letter issued in August 2025, in which the FDA requested additional evidence to support the application but did not raise concerns related to safety or manufacturing. After subsequent meetings with the agency, Saol conducted additional analyses using existing clinical data rather than initiating a new trial.
The updated submission includes further evaluation of survival outcomes, functional measures, mechanistic data, and long-term safety from prior studies. SL1009 has been studied in multiple clinical trials, including two Phase 3 studies and open-label extension data.
PDCD is a genetic disorder that impairs cellular energy production, often leading to lactic acidosis, neurological impairment, and early mortality. The condition typically presents in infancy or early childhood and has limited treatment options.
SL1009 has received Priority Review, Orphan Drug, and Rare Pediatric Disease designations from the FDA. If approved, the therapy is expected to be used alongside a companion genetic test designed to guide dosing.
The FDA will assign a new target action date upon acceptance of the resubmitted application.
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