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 an NDA resubmission from Saol Therapeutics.
What is being decided
Saol Therapeutics has an 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.
Frequently asked questions
When will the FDA decide on SL1009?
The FDA's target date (PDUFA date) for SL1009 in Pyruvate dehydrogenase complex deficiency is December 30, 2026.
Who disclosed it: Saol Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Saol announcement
What is SL1009 being reviewed for?
Saol Therapeutics submitted an NDA resubmission for SL1009 in Pyruvate dehydrogenase complex deficiency.
What to know: Resubmission for a rare metabolic disorder with no approved treatment.
How much will SL1009 cost?
Saol Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the SL1009 decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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 daily.