SL1009 (sodium dichloroacetate) for Pyruvate dehydrogenase complex deficiency
The FDA is expected to decide on SL1009 for Pyruvate dehydrogenase complex deficiency by December 30, 2026, under a NDA resubmission from Saol Therapeutics.
What is being decided
Saol Therapeutics has a NDA resubmission under FDA review for SL1009 (sodium dichloroacetate) in Pyruvate dehydrogenase complex deficiency. Resubmission for a rare metabolic disorder with no approved treatment.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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Frequently asked questions
When will the FDA decide on SL1009?
The FDA's target decision date (PDUFA date) for SL1009 in Pyruvate dehydrogenase complex deficiency is December 30, 2026, disclosed by Saol Therapeutics. The agency can act before this date and occasionally runs past it.
What is SL1009 being reviewed for?
Saol Therapeutics submitted a NDA resubmission for SL1009 in Pyruvate dehydrogenase complex deficiency. Resubmission for a rare metabolic disorder with no approved treatment.
What happens after the SL1009 decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Saol announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.