Evicenter
P&T meetings

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 descriptionPlace of product in therapyApproaches to treatment

Other product development or post-marketing obligations required by the FDA

4 evidence topics · 2 sources

Original FDA requirement for additional effectiveness evidence

“at least one new adequate and well-controlled trial” (opens the source at this quote in a new tab)

FDA-requested cardiac electrophysiology evaluation

“Conduct a thorough QT/QTc study” (opens the source at this quote in a new tab)

FDA-requested food-effect evaluation

“effect of food on the PK of DCA.” (opens the source at this quote in a new tab)

Subsequent sponsor-reported resubmission pathway

“proceed directly to resubmission without conducting an additional trial” (opens the source at this quote in a new tab)