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SL1009 (sodium dichloroacetate)

Pyruvate dehydrogenase complex deficiency

Manufacturer
Saol Therapeutics
Regulatory submission
NDA resubmitted June 2026
Launch
Not announced
Last updated
78 sources

Clinical evidence

Chronic treatment of mitochondrial disease with dichloroacetate

7 evidence topics · 2 sources

Objective
Location and study date
Study design
Eligibility criteria

No evidence found.

Treatment
Study outcomes
Rationale for using blood and cerebrospinal fluid lactate as the biochemical outcomes

No evidence found.

Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets

No evidence found.

Results
Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations
Summary

The study followed 37 participants with various mitochondrial disorders using an open-label format and variable treatment duration. These observations do not provide a randomized estimate of treatment effect in PDCD. Diagnostic heterogeneity and unblinded outcome assessment limit attribution of neurologic changes to dichloroacetate.