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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 the FDA is deciding on SL1009
The FDA is reviewing Saol Therapeutics' resubmitted application to approve SL1009 (sodium dichloroacetate) for pyruvate dehydrogenase complex deficiency, sent back after the FDA turned down an earlier version. Resubmission for a rare metabolic disorder with no approved treatment.
Who the SL1009 decision matters to
Pyruvate dehydrogenase complex deficiency (PDCD) is a rare genetic mitochondrial disorder in which cells cannot fully turn carbohydrates into energy, causing lactic acid buildup and damage that mostly affects the developing brain.
Prevalence: The exact number is unknown (MedlinePlus Genetics); Saol Therapeutics, which is developing a treatment, said in December 2024 that an estimated 300 to 500 patients are treated in US expert centers and that overall prevalence may be as high as 2,000. See our full Pyruvate Dehydrogenase Complex Deficiency page for current treatments, recruiting trials, and community resources.
What an approval or a rejection of SL1009 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. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Pyruvate Dehydrogenase Complex Deficiency treatment stands today
Read our full Pyruvate Dehydrogenase Complex Deficiency treatment summary
The FDA is due to decide on SL1009 (sodium dichloroacetate, or DCA) from Saol Therapeutics by December 30, 2026; it would be the first approved drug for PDCD. The FDA turned down the first application on August 27, 2025. At later meetings the FDA advised more survival analyses, and Saol resubmitted on June 30, 2026 without running a new trial.
In the Phase 3 SL1009-01 trial (NCT02616484) of 34 children, the main motor score was not met during the double-blind phase; Saol reports better motor scores with longer treatment and better survival than a matched comparison group, results presented on a poster rather than in a published paper. DCA can damage nerves at high doses, so dosing is set with a GSTZ1 gene test.
An expanded access program is listed (NCT06931262).
Two other trials are recruiting: glycerol phenylbutyrate (NCT06887777) and triheptanoin in children (NCT06340685).
The Pyruvate Dehydrogenase Complex Deficiency page has every treatment and trial →Meanwhile, 4 Pyruvate Dehydrogenase Complex Deficiency studies are open or about to open
Whatever the FDA decides here, research on Pyruvate Dehydrogenase Complex Deficiency does not stop. Of these, 2 test a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Pyruvate Dehydrogenase Complex Deficiency. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
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.
Is there already an FDA-approved treatment for Pyruvate Dehydrogenase Complex Deficiency?
No. No medicine's current FDA label names Pyruvate Dehydrogenase Complex Deficiency, checked October 21, 2026.
Check: the Pyruvate Dehydrogenase Complex Deficiency page also searches FDA drug labels for approved treatments.
Can I get SL1009 before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 4 Pyruvate Dehydrogenase Complex Deficiency studies are open or about to open, 2 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Saol Therapeutics directly. Registered programs are listed on ClinicalTrials.gov.
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.