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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

PDCD case monitored by localized proton magnetic resonance spectroscopy

7 evidence topics · 1 source

Objective
Location and study date

No evidence found.

Study design
Eligibility criteria

No evidence found.

Treatment
Study outcomes
Rationale for using brain lactate as a biochemical outcome
Validation as a predictor of clinical benefit

No evidence found.

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

Not applicable.

Results
Participant disposition

No evidence found.

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

No evidence found.

Safety results

No evidence found.

Study limitations
Summary

This single-case observation links treatment withdrawal with increased brain lactate and recurrent convulsions. It lacks a randomized comparison and cannot establish a general treatment effect, a validated surrogate relationship, or the incidence of treatment-related harm.