Name: SL1009 (sodium dichloroacetate) in Pyruvate dehydrogenase complex deficiency: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

8 evidence topics · 5 sources

FDA approval status

“Not FDA Approved for Orphan Indication” (opens the source at this quote in a new tab)

FDA submission and anticipated action date

“Saol resubmitted the NDA on June 30, 2026,” (opens the source at this quote in a new tab)
“a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2026.” (opens the source at this quote in a new tab)

Regulatory submission: NDA resubmitted June 2026

“Saol resubmitted the NDA on June 30, 2026, after a productive Type A meeting in December 2025 and a Type C meeting in March 2026.” (opens the source at this quote in a new tab)

Launch

No evidence found.

Resubmission classification

“The FDA acknowledged the resubmission as complete, classified it as Class 2,” (opens the source at this quote in a new tab)

Special FDA designations

“06/11/1990” (opens the source at this quote in a new tab)
“Treatment of congenital lactic acidosis” (opens the source at this quote in a new tab)

Fast Track designation

“the FDA has granted Fast Track Designation for Dichloroacetate (DCA, SL-1009)” (opens the source at this quote in a new tab)

Additional FDA designations

“SL1009 has been granted Orphan Drug, Priority Review, and Rare Pediatric Disease Designations by the FDA.” (opens the source at this quote in a new tab)

FDA Advisory Committee

“No concerns were raised by the FDA about the adequacy of the filing or the need for an advisory committee meeting.” (opens the source at this quote in a new tab)