Privately held, clinical-stage pharmaceutical company Saol Therapeutics announced on Tuesday that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA).

DCA will be used with a proprietary genetic test to treat an orphan paediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD), a rare and life-threatening mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. The FDA granted Priority Review for the NDA and has set a goal date of 27 May 2025 under the Prescription Drug User Fee Act (PDUFA).

SL1009 has previously been granted Orphan Drug and Fast Track Designations. It was also granted Rare Pediatric Disease Designation by the FDA and thus is eligible for a Priority Review Voucher (PRV),

The NDA is supported by results from a Phase 3 double-blind placebo-controlled cross-over study (SL1009-01) and a survival study (SL1009-02).