SAOL THERAPEUTICS INC
Clinical Trials
4
Trial Phases
2 Phases
Drug Approvals
2
Clinical Trials
Distribution across different clinical trial phases (3 trials with phase data)• Click on a phase to view related trials
Expanded Access Treatment Protocol With DCA for Patients With PDCD
- Conditions
- Pyruvate Dehydrogenase Complex Deficiency
- First Posted Date
- 2025-04-17
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Saol Therapeutics Inc
- Registration Number
- NCT06931262
Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain
- Conditions
- Osteoarthritis, Knee Pain
- Interventions
- Drug: Placebo
- First Posted Date
- 2022-07-22
- Last Posted Date
- 2023-08-29
- Lead Sponsor
- Saol Therapeutics Inc
- Target Recruit Count
- 132
- Registration Number
- NCT05470608
- Locations
- 🇺🇸
Denver Spine & Pain Institute, Greenwood Village, Colorado, United States
🇺🇸International Spine, Pain & Performance Center, Washington, District of Columbia, United States
🇺🇸Prime Medical Research, Coral Gables, Florida, United States
Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity
- First Posted Date
- 2022-04-05
- Last Posted Date
- 2023-09-06
- Lead Sponsor
- Saol Therapeutics Inc
- Target Recruit Count
- 32
- Registration Number
- NCT05311215
- Locations
- 🇺🇸
TIRR Memorial Hermann Research Center, Houston, Texas, United States
🇺🇸Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency:
- Conditions
- Pyruvate Dehydrogenase Complex Deficiency
- Interventions
- First Posted Date
- 2015-11-30
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Saol Therapeutics Inc
- Target Recruit Count
- 34
- Registration Number
- NCT02616484
- Locations
- 🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸Children's Hospital of Orange County, Orange, California, United States
🇺🇸Stanford University, Stanford, California, United States
News
FDA Issues Complete Response Letter for Saol's SL1009 Treatment for Rare Pediatric Mitochondrial Disease
The FDA issued a Complete Response Letter for Saol Therapeutics' SL1009 (sodium dichloroacetate) New Drug Application, requiring additional deficiencies to be addressed before approval for treating Pyruvate Dehydrogenase Complex Deficiency.
FDA Grants Priority Review to Saol Therapeutics' SL1009 for Rare Pediatric Mitochondrial Disorder
The FDA has accepted Saol Therapeutics' NDA for SL1009 (sodium dichloroacetate) with Priority Review for treating Pyruvate Dehydrogenase Complex Deficiency (PDCD).