Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate deoxycholic acid and related bile acid regimens across metabolic and hepatobiliary conditions, including obesity, primary biliary cirrhosis, nonalcoholic steatohepatitis, transthyretin amyloidosis, toxic hepatitis, and end-stage kidney disease. Sponsored by various commercial entities and academic institutions, these studies encompass completed, active, recruiting, terminated, and withdrawn statuses. These investigations primarily assess lipid profiles, adipokine dynamics, and lipoprotein metabolism following therapeutic intervention.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06755541 | RECRUITING | Primary Biliary Cholangitis (PBC) |
Xijing Hospital of Digestive Diseases |
2024-01-30 | PHASE3 |
| NCT07296458 | RECRUITING | Primary Biliary Cholangitis (PBC) |
Xijing Hospital of Digestive Diseases |
2025-12-15 | PHASE3 |
| NCT06842472 | NOT_YET_RECRUITING | Breast Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-02 | PHASE2 |
| NCT07378761 | NOT_YET_RECRUITING | Immune-Mediated Cholestasis |
University Hospital, Montpellier |
2026-12 | PHASE2 |
| NCT07717242 | RECRUITING | Bladder Urothelial Carcinoma; Bladder Cancer |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2026-07-01 | PHASE2 |
| NCT06591468 | ENROLLING_BY_INVITATION | Primary Biliary Cholangitis (PBC) |
Han Ying |
2024-10-30 | PHASE2; PHASE3 |
| NCT05925309 | RECRUITING | Biliary Atresia; Cholangitis; Anti-Bacterial Agents |
Children's Hospital of Fudan University |
2023-07-01 | |
| NCT05751967 | RECRUITING | Primary Biliary Cholangitis |
Xijing Hospital of Digestive Diseases |
2023-02-22 | PHASE3 |
| NCT07664020 | NOT_YET_RECRUITING | Chronic Liver Disease |
Institute of Liver and Biliary Sciences, India |
2026-06-18 | |
| NCT04924868 | RECRUITING | Acute Pancreatitis Due to Gallstones |
Hospital General Universitario de Alicante |
2021-11-10 | PHASE3 |
| NCT07273734 | NOT_YET_RECRUITING | Hepatic Encephalopathy (HE); TIPS |
West China Hospital |
2026-01-01 | |
| NCT06884748 | NOT_YET_RECRUITING | Clostridioides Difficile Infection |
Medical College of Wisconsin |
2026-05-01 | EARLY_PHASE1 |
| 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 | |
| NCT06756490 | RECRUITING | Moderate or Severe Submental Fullness |
Sichuan Huiyu Pharmaceutical Co., Ltd |
2024-12-26 | PHASE1 |
| NCT06684106 | RECRUITING | Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance |
First Affiliated Hospital Xi'an Jiaotong University |
2024-11-25 | |
| NCT06610760 | RECRUITING | Gastric Intestinal Metaplasia |
Yongquan Shi |
2024-11-12 | PHASE4 |
| NCT07525401 | NOT_YET_RECRUITING | Hepatitis A; Hepatitis E Virus Infection |
Combined Military Hospital, Pakistan |
2026-04 | |
| NCT07672860 | RECRUITING | Kidney Cancer |
Jinling Hospital, China |
2026-06-01 | PHASE2 |
| NCT06517862 | RECRUITING | Neonatal Hyperbilirubinemia |
Amira Adel Fouly |
2024-09-01 | PHASE4 |
| NCT07014163 | RECRUITING | Lipoma |
Espad Pharmed |
2024-05-21 | |
| NCT03724175 | TERMINATED | Ulcerative Colitis; Pouchitis |
Stanford University |
2019-08-26 | PHASE2; PHASE3 |
| NCT07102979 | TERMINATED | Liver Fibrosis |
Chang Gung Memorial Hospital |
2024-01-01 | |
| NCT06260748 | WITHDRAWN | Cerebrotendinous Xanthomatoses |
Leadiant Biosciences, Inc. |
2024-05-27 | PHASE3 |
| NCT03004118 | UNKNOWN | Functional Dyspepsia |
Universitaire Ziekenhuizen KU Leuven |
2017-01 | PHASE4 |
| NCT06591455 | COMPLETED | Primary Biliary Cholangitis (PBC) |
Han Ying |
2024-09-14 | EARLY_PHASE1 |
| NCT06132165 | COMPLETED | Neurofibromatosis 1 |
Massachusetts General Hospital |
2024-03-01 | 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 | |
| NCT06918080 | ACTIVE_NOT_RECRUITING | Non Alcoholic Fatty Liver Diseases (NAFLD); Obesity and Overweight; Acute Lymphoblastic Leukemia |
Ain Shams University |
2023-11-19 | PHASE4 |
| NCT04650243 | RECRUITING | Primary Biliary Cholangitis |
Peking Union Medical College Hospital |
2020-01-21 | PHASE4 |
| NCT04810156 | UNKNOWN | Hepatitis, Drug-Induced |
Inge Marie Svane |
2021-04-07 | PHASE2 |
| NCT05753852 | UNKNOWN | Amyotrophic Lateral Sclerosis |
Humanitas Mirasole SpA |
2021-10-25 | PHASE3 |
| NCT05467553 | UNKNOWN | Hepatitis D |
National Taiwan University Hospital |
2023-02-24 | PHASE2 |
| NCT06120036 | COMPLETED | Neurofibromatosis 1 |
Massachusetts General Hospital |
2022-12-06 | PHASE1 |
| NCT04407650 | ACTIVE_NOT_RECRUITING | Gestational Diabetes |
King's College London |
2021-07-01 | PHASE4 |
| NCT07004010 | COMPLETED | Flank Fat |
Espad Pharmed |
2024-08-01 | |
| NCT06091787 | COMPLETED | Liver Regeneration; Ursodeoxycholic Acid; Partial Liver Resection |
Institute of Liver and Biliary Sciences, India |
2023-09-01 | |
| NCT05902468 | UNKNOWN | Diabetes Mellitus, Type 2 |
Tanta University |
2023-06-28 | PHASE2; PHASE3 |
| NCT05416580 | UNKNOWN | Diabetes Mellitus, Type 2 |
University of Banja Luka |
2022-09-12 | PHASE3 |
| NCT07072949 | COMPLETED | Type 2 Diabetes Mellitus |
University of Banja Luka |
2023-01-03 | PHASE1 |
| NCT06509438 | COMPLETED | Submental Fullness |
Espad Pharmed |
2023-04-10 | |
| NCT05526807 | TERMINATED | Clostridioides Difficile Infection |
Nottingham University Hospitals NHS Trust |
2019-05-08 | |
| NCT05973370 | COMPLETED | Rheumatoid Arthritis |
Tanta University |
2023-05-01 | PHASE2 |
| NCT04542473 | UNKNOWN | SEPSIS; MALNUTRITION, CHILD |
University of Oxford |
2021-07-01 | PHASE2; PHASE3 |
| NCT05690646 | COMPLETED | Cardiac Surgery |
China National Center for Cardiovascular Diseases |
2023-01-28 | PHASE4 |
| NCT05659654 | COMPLETED | COVID-19 |
Institute of Hematology & Blood Diseases Hospital, China |
2022-12-16 | PHASE1; PHASE2 |
| NCT05832697 | COMPLETED | Healthy Subject |
Daewoong Pharmaceutical Co. LTD. |
2022-01-27 | PHASE1 |
| NCT04617561 | UNKNOWN | Hepatitis, Autoimmune; Primary Biliary Cholangitis |
West China Hospital |
2020-11-01 | PHASE4 |
| NCT06180057 | COMPLETED | Cerebrotendinous Xanthomatoses |
Humanis Saglık Anonim Sirketi |
2022-06-12 | PHASE1 |
| NCT02936596 | UNKNOWN | Hepatitis, Autoimmune; Cholangitis; Liver Cirrhosis, Biliary; Cholestasis |
Xiaoli Fan |
2016-12 | |
| 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 |
| NCT04786795 | UNKNOWN | Patients With Dyspeptic Symptoms After Cholecystectomy |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
2021-03-01 | PHASE4 |
| NCT03602976 | TERMINATED | Hepatic Sarcoidosis, Elevated Alkaline Phosphatase |
Ethan Weinberg |
2018-08-20 | PHASE2 |
| NCT04910178 | COMPLETED | Diabetes Type 2; NAFLD |
Asmaa Abdelfattah Elsayed |
2020-12-01 | PHASE4 |
| NCT04640571 | COMPLETED | Bile Salt Export Pump (BSEP) Transporter; Polysorbate 80 |
University of Maryland, Baltimore |
2021-04-01 | PHASE4 |
| 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 | |
| NCT02965911 | WITHDRAWN | Primary Biliary Cirrhosis |
Beijing 302 Hospital |
2016-01 | PHASE1; PHASE2 |
| NCT04751188 | UNKNOWN | Primary Biliary Cirrhosis |
Instituto Mexicano del Seguro Social |
2020-10-02 | PHASE3 |
| NCT03664596 | COMPLETED | Non-alcoholic Steatohepatitis |
Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan |
2018-08-01 | |
| NCT03665519 | COMPLETED | Primary Biliary Cirrhosis |
National Scientific Medical Center, Kazakhstan |
2018-01-03 | |
| NCT04089722 | COMPLETED | Brassiere Strap Fat (BSF); Bra Strap Fat (BSF) |
Juva Skin & Laser Center |
2019-07-26 | PHASE4 |
| NCT03284034 | TERMINATED | Upper Back Fat |
Northwestern University |
2017-11-27 | |
| NCT04977661 | COMPLETED | Nonalcoholic Steatohepatitis (NASH) |
Kafrelsheikh University |
2020-02-01 | PHASE4 |
| NCT04054011 | COMPLETED | Adiposity |
University of California, San Diego |
2019-07-05 | EARLY_PHASE1 |
| NCT03201952 | TERMINATED | Glucose Intolerance; Gastric Bypass Surgery |
Vanderbilt University Medical Center |
2018-02-01 | PHASE1 |
| NCT03056274 | UNKNOWN | Intrahepatic Cholestases; Pregnancy Complications |
Epsom and St Helier University Hospitals NHS Trust |
2019-01 | PHASE2; PHASE3 |
| NCT03168555 | COMPLETED | Bile Acid Malabsorption; Cholelithiasis |
Zealand University Hospital |
2017-06-22 | PHASE4 |
| NCT02937012 | UNKNOWN | Primary Biliary Cirrhosis |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2016-10 | PHASE3 |
| NCT02721862 | UNKNOWN | Cholelithiasis |
American University of Beirut Medical Center |
2016-03 | PHASE3 |
| NCT03659058 | COMPLETED | Fibrosis, Liver |
Zagazig University |
2016-03-02 | |
| NCT02952963 | COMPLETED | Severe Obesity |
Hvidovre University Hospital |
2016-10 | PHASE4 |
| NCT03489889 | COMPLETED | Ursodeoxycholic Acid; Primary Biliary Cirrhosis |
University of Sao Paulo General Hospital |
2016-12 | |
| NCT01149304 | COMPLETED | Colorectal Cancer; Liver Metastases; Irradiation Damage; Radiation Induced Liver Disease |
University of Magdeburg |
2009-06 | PHASE2 |
| NCT02943707 | UNKNOWN | Liver Diseases |
Wenzhou Medical University |
2016-10 | PHASE2 |
| NCT02472509 | TERMINATED | Hemolytic Disorders; Gallstones |
Shaare Zedek Medical Center |
2014-12 | PHASE4 |
| 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 |
| NCT02876484 | COMPLETED | Severe Obesity |
Hvidovre University Hospital |
2016-06 | PHASE4 |
| NCT02338635 | UNKNOWN | End-Stage Kidney Disease |
Ewha Womans University |
2015-07 | PHASE4 |
| NCT02033876 | COMPLETED | Type 2 Diabetes Mellitus |
Mayo Clinic |
2013-10 | PHASE2 |
| NCT01088607 | COMPLETED | Primary Sclerosing Cholangitis |
University of Tennessee |
2010-10 | PHASE1 |
| NCT02789644 | UNKNOWN | Aged |
Seoul National University Hospital |
2016-05 | 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 |
| NCT02163902 | COMPLETED | Submental Fat; Healthy |
Kythera Biopharmaceuticals |
2013-12 | PHASE3 |
| NCT02654496 | Completed | Obesity |
North Dakota State University |
2016-01 | -- |
| NCT01899703 | COMPLETED | Cholestasis, Intrahepatic |
GlaxoSmithKline |
2014-03-10 | PHASE2 |
| NCT02021110 | COMPLETED | Polycystic Liver Disease; Polycystic Kidney, Autosomal Dominant |
Radboud University Medical Center |
2013-12 | PHASE2 |
| NCT02123134 | COMPLETED | Moderate to Severe Convexity of Submental Fat; Safety; Efficacy |
Kythera Biopharmaceuticals |
2014-04 | PHASE3 |
| NCT02415777 | COMPLETED | Fatigue |
Daewoong Pharmaceutical Co. LTD. |
2014-10 | PHASE4 |
| NCT02035267 | COMPLETED | Moderate to Severe Convexity of Submental Fat; Safety; Efficacy |
Kythera Biopharmaceuticals |
2014-01 | PHASE3 |
| NCT02340247 | COMPLETED | Severe Obesity |
Hvidovre University Hospital |
2014-11 | PHASE4 |
| NCT01904058 | COMPLETED | PBC; Primary Biliary Cirrhosis |
Mirum Pharmaceuticals, Inc. |
2013-08 | PHASE2 |
| NCT02418130 | COMPLETED | Fatigue |
Daewoong Pharmaceutical Co. LTD. |
2014-10 | PHASE4 |
| NCT02016365 | COMPLETED | Transthyretin Amyloidosis; Cardiomyopathy |
Umeå University |
2012-02 | PHASE2 |
| NCT02007434 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2013-12 | PHASE3 |
| NCT01097304 | COMPLETED | Barrett Esophagus; Esophageal Carcinoma |
National Cancer Institute (NCI) |
2010-04 | PHASE2 |
| NCT01865812 | Completed | Primary Biliary Cirrhosis |
Intercept Pharmaceuticals |
2013-12-03 | Phase 2 |
| NCT01440309 | UNKNOWN | Primary Biliary Cirrhosis |
Robert Chunhua Zhao, MD, PhD |
2011-11 | PHASE1 |
| NCT01226823 | WITHDRAWN | Intrahepatic Cholestasis of Pregnancy |
University of Bologna |
2010-11 | PHASE3 |
| NCT01688375 | UNKNOWN | Obstructive Jaundice |
University Clinical Centre of Kosova |
2012-12 | PHASE2 |
| NCT01666223 | COMPLETED | Type 2 Diabetes; Obesity |
University Hospital, Gentofte, Copenhagen |
2012-11 | |
| NCT01426373 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2011-08 | PHASE3 |
| NCT01546142 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2012-03 | PHASE3 |
| NCT01542034 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2012-02 | PHASE3 |
| NCT00858858 | COMPLETED | Gastroesophageal Reflux Disease |
US Department of Veterans Affairs |
2009-03 | |
| NCT01337440 | UNKNOWN | Type 2 Diabetes Mellitus; Chronic Liver Disease |
Kanazawa University |
2010-04 | PHASE4 |
| NCT01857284 | COMPLETED | Primary Biliary Cirrhosis |
Beijing Friendship Hospital |
2009-09 | PHASE3 |
| NCT01829698 | COMPLETED | Cholestatic Liver Disease |
Beijing Trendful Kangjian Medical Information Consulting Limited Company |
2009-08 | PHASE3 |
| NCT00873275 | COMPLETED | Colorectal Cancer |
City of Hope Medical Center |
2009-03-11 | PHASE1 |
| NCT01294644 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2011-01 | PHASE3 |
| NCT01305577 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2010-12 | PHASE3 |
| NCT01674946 | COMPLETED | Echolocation |
University Hospital, Basel, Switzerland |
2011-09 | PHASE1 |
| NCT00877604 | COMPLETED | Amyotrophic Lateral Sclerosis |
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
2008-06 | PHASE2 |
| NCT00808743 | COMPLETED | Familial Adenomatous Polyposis; Duodenal Neoplasms; Duodenal Polyps |
Radboud University Medical Center |
2009-05 | PHASE2; PHASE3 |
| NCT01319916 | Completed | Healthy |
Kythera Biopharmaceuticals |
2010-12 | Phase 1 |
| NCT01032889 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2009-12 | PHASE2 |
| NCT01510860 | COMPLETED | Primary Biliary Cirrhosis |
Dr. Falk Pharma GmbH |
2008-11 | PHASE4 |
| NCT01141322 | UNKNOWN | Hepatitis, Toxic |
Taipei Veterans General Hospital, Taiwan |
2007-08 | PHASE4 |
| NCT00018694 | WITHDRAWN | Cerebrotendinous Xanthomatosis |
US Department of Veterans Affairs |
1999-10 | |
| NCT01548079 | COMPLETED | Non-alcoholic Fatty Liver Disease; Morbid Obesity |
Sahlgrenska University Hospital |
2008-10 | |
| NCT00912301 | COMPLETED | Constipation-predominant Irritable Bowel Syndrome |
Mayo Clinic |
2009-04 | PHASE2 |
| NCT00550862 | TERMINATED | Liver Cirrhosis, Biliary |
Intercept Pharmaceuticals |
2007-10 | PHASE2 |
| NCT00134758 | UNKNOWN | Adenomatous Polyposis Coli, Familial |
Assistance Publique - Hôpitaux de Paris |
2004-10 | PHASE2; PHASE3 |
| NCT00618618 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2008-04 | PHASE2 |
| NCT00618722 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2007-08 | PHASE1; PHASE2 |
| NCT00608842 | COMPLETED | Lipoma |
Kythera Biopharmaceuticals |
2007-11 | PHASE2 |
| NCT00059202 | TERMINATED | Primary Sclerosing Cholangitis |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2002-07 | PHASE2; PHASE3 |
| NCT01073202 | COMPLETED | Liver Transplantation; Ischemia-reperfusion Injury; Cholestasis |
Shanghai Jiao Tong University School of Medicine |
2005-05 | |
| NCT00422188 | COMPLETED | Lipoma |
Kythera Biopharmaceuticals |
2007-01 | PHASE1 |
| NCT01576458 | COMPLETED | Intrahepatic Cholestasis; Pregnancy |
Turku University Hospital |
1998-01 | PHASE3 |
| NCT00004442 | TERMINATED | Infantile Refsum's Disease; Zellweger Syndrome; Bifunctional Enzyme Deficiency; Adrenoleukodystrophy |
University of Cincinnati |
||
| NCT00465751 | COMPLETED | Metabolic Syndrome; Familial Hypertriglyceridemia; Familial Combined Hyperlipidemia |
University Hospital, Basel, Switzerland |
2004-10 | EARLY_PHASE1 |
| NCT00161083 | COMPLETED | Cholecystolithiasis |
UMC Utrecht |
2001-11 | PHASE4 |
| NCT00285597 | UNKNOWN | Heart Failure, Congestive |
National Heart and Lung Institute |
2004-05 | PHASE2 |
| NCT00200343 | COMPLETED | Chronic Hepatitis C |
Tanabe Pharma Corporation |
2002-07 | PHASE3 |
| NCT00004441 | COMPLETED | Cystic Fibrosis |
Children's Hospital Medical Center, Cincinnati |
1997-09 | |
| NCT00004346 | UNKNOWN | Cerebrotendinous Xanthomatosis |
National Center for Research Resources (NCRR) |
1996-01 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-01-08)
Check the
Deoxycholic acid
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.