3 December 2024 - Saol Therapeutics today announced the submission of a new drug application to the US FDA for approval of SL1009, sodium dichloroacetate oral solution for use with a proprietary genetic test, for the treatment of an orphan paediatric mitochondrial disease, pyruvate dehydrogenase complex deficiency. 

SL1009 has been granted orphan drug, fast track and rare paediatric disease designations by the FDA and is thus eligible for priority review and a priority review voucher.

Read Saol Therapeutics press release