Clinical Trials

Numerous clinical trials evaluate therapies across medical conditions such as metastatic breast cancer, lung cancer, urothelial carcinomas, stroke, and amyotrophic lateral sclerosis. Spanning Phase 1 through Phase 4, early feasibility, and unassigned trial phases, these studies reflect recruitment statuses ranging from completed and actively recruiting to terminated or not yet recruiting. Prominent sponsors include academic medical centers such as Memorial Sloan Kettering Cancer Center, university health networks, and industry leaders like Novartis Pharmaceuticals and Intercept Pharmaceuticals.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07296458 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2025-12-15 PHASE3
NCT07378761 NOT_YET_RECRUITING
Immune-Mediated Cholestasis
University Hospital, Montpellier
 2026-12 PHASE2
NCT06591468 ENROLLING_BY_INVITATION
Primary Biliary Cholangitis (PBC)
Han Ying
 2024-10-30 PHASE2; PHASE3
NCT06656780 NOT_YET_RECRUITING
Stress, Psychological
The University of Texas Health Science Center, Houston
 2025-08-31
NCT07273734 NOT_YET_RECRUITING
Hepatic Encephalopathy (HE); TIPS
West China Hospital
 2026-01-01
NCT06294847 RECRUITING
Retinal Detachment
Hopital Foch
 2024-08-20 PHASE3
NCT06922669 RECRUITING
Drug Induced Liver Injury
General Hospital of Shenyang Military Region
 2025-06-24
NCT07110987 RECRUITING
Hyperbilirubinemia, Neonatal Indirect
Tishreen University Hospital
 2025-06-26
NCT06684106 RECRUITING
Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance
First Affiliated Hospital Xi'an Jiaotong University
 2024-11-25
NCT07672860 RECRUITING
Kidney Cancer
Jinling Hospital, China
 2026-06-01 PHASE2
NCT05120284 ACTIVE_NOT_RECRUITING
Glioblastoma Multiforme
University of Florida
 2022-07-01 PHASE2
NCT03724175 TERMINATED
Ulcerative Colitis; Pouchitis
Stanford University
 2019-08-26 PHASE2; PHASE3
NCT06260748 WITHDRAWN
Cerebrotendinous Xanthomatoses
Leadiant Biosciences, Inc.
 2024-05-27 PHASE3
NCT02616484 ACTIVE_NOT_RECRUITING
Pyruvate Dehydrogenase Complex Deficiency
Saol Therapeutics Inc
 2020-07-14 PHASE3
NCT06591455 COMPLETED
Primary Biliary Cholangitis (PBC)
Han Ying
 2024-09-14 EARLY_PHASE1
NCT07068191 RECRUITING
Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD); Fatty Liver; Fatty Liver, Alcoholic; Fatty Liver, Nonalcoholic; Fatty Liver Disease
Phenomen Pharma
 2025-06-19
NCT05753852 UNKNOWN
Amyotrophic Lateral Sclerosis
Humanitas Mirasole SpA
 2021-10-25 PHASE3
NCT06170515 UNKNOWN
Diabetes
Foundation for Innovative New Diagnostics, Switzerland
 2023-04-03
NCT05416580 UNKNOWN
Diabetes Mellitus, Type 2
University of Banja Luka
 2022-09-12 PHASE3
NCT05500937 UNKNOWN
Diabetes Mellitus
First Affiliated Hospital Xi'an Jiaotong University
 2021-03-01 PHASE2; PHASE3
NCT05849558 UNKNOWN
Chronic Liver Disease
MinaPharm Pharmaceuticals
 2022-02-22 PHASE4
NCT06073106 Not yet recruiting
Stroke|Traumatic Brain Injury|Knee Osteoarthritis|Breast Cancer
Tan Tock Seng Hospital|Rehabilitation Research Institute of Singapore (RRIS)|Woodlands Health (WH)
 2023-12 --
NCT05973370 COMPLETED
Rheumatoid Arthritis
Tanta University
 2023-05-01 PHASE2
NCT05810623 Not yet recruiting
Upper Urinary Tract Urothelial Carcinoma|Bladder Cancer
David D''Andrea|Medical University of Vienna
 2023-06-01 Phase 3
NCT05646485 Recruiting
Bladder Cancer|Urothelial Carcinoma|Hematuria|Smoking Cessation
University of Texas Southwestern Medical Center
 2023-05-05 Not Applicable
NCT06180057 COMPLETED
Cerebrotendinous Xanthomatoses
Humanis Saglık Anonim Sirketi
 2022-06-12 PHASE1
NCT05460533 Recruiting
B-cell Acute Lymphoblastic Leukemia
Memorial Sloan Kettering Cancer Center|Novartis Pharmaceuticals
 2022-07-12 Phase 2
NCT04834557 COMPLETED
Rheumatoid Arthritis
Tanta University
 2021-11-01 PHASE2
NCT02967250 COMPLETED
Parkinson Disease
University of Minnesota
 2020-04-01 PHASE1
NCT06127355 COMPLETED
Gestational Diabetes
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
 2021-03-03 PHASE3
NCT03602976 TERMINATED
Hepatic Sarcoidosis, Elevated Alkaline Phosphatase
Ethan Weinberg
 2018-08-20 PHASE2
NCT03678480 WITHDRAWN
Primary Sclerosing Cholangitis; Cholangitis; Cholangitis, Sclerosing; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adolescent
HighTide Therapeutics (Hong Kong) Limited
 2021-03-01 PHASE2
NCT05043194 UNKNOWN
Cholestasis of Parenteral Nutrition
Wei Liu
 2021-01-01
NCT04046081 COMPLETED
Endometriosis
University of Edinburgh
 2019-11-19
NCT02965911 WITHDRAWN
Primary Biliary Cirrhosis
Beijing 302 Hospital
 2016-01 PHASE1; PHASE2
NCT04899362 COMPLETED
Remote Ischemic Conditioning
The First Hospital of Jilin University
 2021-05-20
NCT03578055 UNKNOWN
Cholecystitis, Acute; Cholecystitis, Chronic
Ewha Womans University Mokdong Hospital
 2018-04-24 PHASE3
NCT02841306 COMPLETED
Rhegmatogenous Retinal Detachment
Francine Behar-Cohen
 2016-07 PHASE1
NCT03000218 UNKNOWN
Overweight; Abnormal Liver Function Tests
Seoul National University Hospital
 2016-08 PHASE1
NCT02690285 COMPLETED
Healthy
University of Florida
 2016-03-01 PHASE1
NCT02965547 COMPLETED
Ischemic Preconditioning
Yi Yang
 2017-01-01
NCT01088607 COMPLETED
Primary Sclerosing Cholangitis
University of Tennessee
 2010-10 PHASE1
NCT02420496 WITHDRAWN
Cholestasis; Liver Disease
The University of Texas Health Science Center at San Antonio
 2016-06 PHASE2
NCT01974336 COMPLETED
Short Bowel Syndrome
Jinling Hospital, China
 2013-01 PHASE4
NCT02622685 COMPLETED
Healthy
Daewoong Pharmaceutical Co. LTD.
 2015-05 PHASE1
NCT02415777 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT01904058 COMPLETED
PBC; Primary Biliary Cirrhosis
Mirum Pharmaceuticals, Inc.
 2013-08 PHASE2
NCT02385032 COMPLETED
Healthy
Daewoong Pharmaceutical Co. LTD.
 2015-02 PHASE1
NCT02418130 COMPLETED
Fatigue
Daewoong Pharmaceutical Co. LTD.
 2014-10 PHASE4
NCT01386632 COMPLETED
Squamous Cell Carcinoma of the Head and Neck
Sanford Health
 2011-05 PHASE2
NCT01111097 COMPLETED
Brain Tumor; Glioblastoma
University of Florida
 2010-04 PHASE1
NCT01083524 COMPLETED
Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated)
University of Alberta
 2010-03 PHASE1
NCT01337440 UNKNOWN
Type 2 Diabetes Mellitus; Chronic Liver Disease
Kanazawa University
 2010-04 PHASE4
NCT00566410 COMPLETED
Neoplasms
AHS Cancer Control Alberta
 2007-12 PHASE1
NCT01829698 COMPLETED
Cholestatic Liver Disease
Beijing Trendful Kangjian Medical Information Consulting Limited Company
 2009-08 PHASE3
NCT01857284 COMPLETED
Primary Biliary Cirrhosis
Beijing Friendship Hospital
 2009-09 PHASE3
NCT00874276 COMPLETED
Congenital Lactic Acidosis
University of Florida
 2009-08
NCT00865514 TERMINATED
Healthy
University of Florida
 2011-08
NCT01674946 COMPLETED
Echolocation
University Hospital, Basel, Switzerland
 2011-09 PHASE1
NCT01029925 TERMINATED
Metastatic Breast Cancer; Lung Cancer
Jonsson Comprehensive Cancer Center
 2009-12 PHASE2
NCT00877604 COMPLETED
Amyotrophic Lateral Sclerosis
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
 2008-06 PHASE2
NCT01510860 COMPLETED
Primary Biliary Cirrhosis
Dr. Falk Pharma GmbH
 2008-11 PHASE4
NCT00703859 WITHDRAWN
Glioblastoma
AHS Cancer Control Alberta
 2008-07 PHASE1
NCT01548079 COMPLETED
Non-alcoholic Fatty Liver Disease; Morbid Obesity
Sahlgrenska University Hospital
 2008-10
NCT00550862 TERMINATED
Liver Cirrhosis, Biliary
Intercept Pharmaceuticals
 2007-10 PHASE2
NCT00540176 COMPLETED
Malignant Gliomas, Glioblastoma Multiforme
University of Alberta
 2007-10 PHASE2
NCT00068913 UNKNOWN
MELAS Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2000-03 PHASE2
NCT00004493 COMPLETED
Lactic Acidosis
University of California, San Diego
 1998-09 PHASE2
NCT00004490 COMPLETED
Lactic Acidosis
University of Florida
 1998-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-29)

Check the Sodium Dichloroacetate (DCA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium Dichloroacetate acts as a selective inhibitor of pyruvate dehydrogenase kinase, specifically targeting PDK2 and PDK4 to derepress mitochondrial potassium-ion channel activity and increase intracellular reactive oxygen species generation. This induction of oxidative stress triggers selective apoptosis and suppresses tumor cell proliferation, providing therapeutic relevance for clinical conditions such as breast cancer and lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.