Drugmaker with rare disease work · based in Roswell, United States · founded 2015 · saolrx.com
Saol Therapeutics Inc works on Pyruvate Dehydrogenase Complex Deficiency, one of the rare diseases we track. It has 1 active clinical trial, though none is looking for new volunteers right now.
Saol Therapeutics is a privately held drug company, founded in 2015, with offices in Roswell, Georgia; Dublin, Ireland; and Hamilton, Bermuda. Its lead drug, SL1009 (sodium dichloroacetate), is an oral solution for pyruvate dehydrogenase complex deficiency, a rare mitochondrial disease, and the FDA is reviewing it again after declining to approve it in August 2025, with a decision due December 30, 2026.
Saol Therapeutics Inc pipeline
Each row lists the diseases Saol Therapeutics Inc is studying at that stage, from the ones closest to approval down to the earliest work.
Phase 3
Large studies, usually the last step before a company asks the FDA for approval.
These are Saol Therapeutics Inc trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
1 trial underway, not taking new volunteers
Underway, not taking new volunteersPhase 3Hasn't posted an update in over a yearNCT02616484
Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency:
The objective of this research study is to conduct a pivotal phase 3 trial of treatment with the investigational drug dichloroacetate (DCA) in young children with deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which no proven treatment exists. The investigators predict that DCA represents targeted potential therapy for PDCD because of its ability to increase both the catalytic activity and stability of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are consistent with this postulate and have led to the designation of DCA as an Orphan Product for congenital lactic acidosis by the Food and Drug Administration.
A novel Observer reported outcome (ObsRO) survey that is completed by study participant's parent/caregiver, is the efficacy outcome measure.
Funding Source - FDA OOPD
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Saol is also developing SL1002 for knee pain and spasticity.
Within its broader pharmaceutical portfolio, Saol Therapeutics Inc has active clinical trial programs and drug development efforts across 1 rare diseases, including Pyruvate Dehydrogenase Complex Deficiency. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.
The clinical trials section below shows active and recruiting rare disease studies sponsored by Saol Therapeutics Inc, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites.
The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.
Keep reading about Saol Therapeutics Inc
Saol Therapeutics Inc is headquartered in Roswell, United States, founded in 2015. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.
Where Saol Therapeutics Inc trials take place
The trials above run at 10 study sites in 1 country. Tap a country to see its states, cities and hospitals.
United States
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Rare diseases Saol Therapeutics Inc works on
Each disease page lists every open trial, not only Saol Therapeutics Inc's, plus approved treatments.
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...
How common: 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
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Saol Therapeutics Inc's own site is saolrx.com, and our help paying for treatment page lists drugmaker programs and charity funds.
1 shared disease, including Pyruvate Dehydrogenase Complex Deficiency
Questions about Saol Therapeutics Inc
Saol Therapeutics is a privately held drug company, founded in 2015, with offices in Roswell, Georgia; Dublin, Ireland; and Hamilton, Bermuda. Its lead drug, SL1009 (sodium dichloroacetate), is an oral solution for pyruvate dehydrogenase complex deficiency, a rare mitochondrial disease, and the FDA is reviewing it again after declining to approve it in August 2025, with a decision due December 30, 2026. Saol is also developing SL1002 for knee pain and spasticity.
Saol Therapeutics Inc has active programs across 1 rare disease: Pyruvate Dehydrogenase Complex Deficiency. Each disease page on Trial Friend shows the latest recruiting trials, FDA-approved treatments, and patient resources.
Saol Therapeutics Inc is a diversified pharmaceutical company headquartered in Roswell, United States, founded in 2015. While it operates across multiple therapeutic areas, it maintains a significant rare disease portfolio with 1 active rare disease program including Pyruvate Dehydrogenase Complex Deficiency. Many of its rare disease treatments hold orphan drug designations from the FDA.
The clinical trials section on this page shows active and recruiting rare disease trials sponsored by Saol Therapeutics Inc, pulled live from ClinicalTrials.gov. Each trial card includes the study phase, recruitment status, conditions being studied, number of trial sites, and a direct link to the full study record. You can also explore individual disease pages to see trials from all sponsors for a specific condition.
To explore enrollment, find a recruiting trial in the clinical trials list on this page and click "View full study" to see the full ClinicalTrials.gov record, which includes eligibility criteria, study locations, and contact information for each trial site. Your doctor can also help determine if a specific trial is appropriate for your condition. Not all trials are open at every location, so check the site list for one near you.
None that we track as of October 2026. No Saol Therapeutics Inc label in the FDA's openFDA database matches a rare disease on Trial Friend, which usually means the company has no approved product yet or its approved drugs are for common conditions.
In development: the trials list on this page shows what Saol Therapeutics Inc is recruiting for now, and the FDA calendar lists any application once a decision date is public.
Saol Therapeutics Inc was founded in 2015 and is headquartered in Roswell, United States. The company has been active for 11 years.