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SAOL THERAPEUTICS INC

🇺🇸United States
Ownership
Holding
Employees
-
Market Cap
-
Website
http://www.saolrx.com

Clinical Trials

4

Active:3
Completed:0

Trial Phases

2 Phases

Phase 2:2
Phase 3:1

Drug Approvals

2

FDA:2

Drug Approvals

VARIZIG

Approval Date
Mar 22, 2023
FDA

Lyvispah

Approval Date
Nov 26, 2021
FDA

Clinical Trials

Distribution across different clinical trial phases (3 trials with phase data)• Click on a phase to view related trials

Phase 2
2 (66.7%)
Phase 3
1 (33.3%)

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

Phase 2
Active, not recruiting
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

and more 12 locations

Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity

Phase 2
Active, not recruiting
Conditions
Spasticity
Interventions
Drug: Placebo
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:

Phase 3
Active, not recruiting
Conditions
Pyruvate Dehydrogenase Complex Deficiency
Interventions
Other: Placebo
Genetic: Genotype
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

and more 7 locations

News

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).

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