Clinical Trials

Numerous clinical trials evaluate hydrocortisone across Phase 1 through Phase 4 for indications such as septic shock, sepsis, adrenal insufficiency, corticotropin deficiency, critical illness, and dermatologic disorders including atopic dermatitis. Sponsored by academic medical institutions, university hospitals, and corporate entities, these studies evaluate outcomes ranging from baseline glucocorticoid dynamics in critically ill patients to anti-inflammatory efficacy in pediatric skin diseases. Across these initiatives, recruitment statuses encompass active, recruiting, completed, terminated, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07072585 NOT_YET_RECRUITING
Stage II T Lymphoblastic Leukemia/Lymphoma; Stage III T Lymphoblastic Leukemia/Lymphoma; Stage IV T Lymphoblastic Leukemia/Lymphoma; T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma
Children's Oncology Group
 2026-08-28 PHASE2; PHASE3
NCT07387926 RECRUITING
Acute Lymphoblastic Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Novartis Pharmaceuticals
 2026-07-05 PHASE1; PHASE2
NCT07612631 RECRUITING
Alcohol Use Disorder
Rajesh Narendran
 2026-06-01 EARLY_PHASE1
NCT06942039 RECRUITING
CNS Embryonal Tumor; CNS, Medulloblastoma; Atypical Teratoid Rhabdoid Tumor; Medulloblastoma, Childhood; Medulloblastoma, Group 3; Medulloblastoma, Group 4; Pineoblastoma; Neuroblastoma; Embryonal Tumor With Multilayered Rosettes; Embryonal Tumor With Abundant Neuropil and True Rosettes; Ependymoblastoma; Medulloepithelioma; CNS Embryonal Tumor With Rhabdoid Features; CNS Embryonal Tumor, Nos
C17 Council
 2025-09-23 EARLY_PHASE1
NCT06892210 RECRUITING
Chronic Obstructive Pulmonary Disease (COPD)
Copenhagen Respiratory Research
 2026-03-10 PHASE4
NCT07686107 NOT_YET_RECRUITING
Leukemia, Myeloid, Acute
Therapeutic Advances in Childhood Leukemia Consortium
 2026-08-31 PHASE2
NCT07703098 NOT_YET_RECRUITING
Adrenal Insufficiency
University Medical Centre Ljubljana
 2026-09-01 PHASE4
NCT06881927 RECRUITING
Sepsis and Septic Shock; Acute Respiratory Failure; Kidney Transplant Recipients; Immunosuppressive Agents
University Hospital, Strasbourg, France
 2026-08-11 PHASE4
NCT04293562 RECRUITING
Acute Myeloid Leukemia
Children's Oncology Group
 2020-07-21 PHASE3
NCT07332325 NOT_YET_RECRUITING
Sepsis; Tuberculosis
University of Virginia
 2026-10 PHASE3
NCT07383103 RECRUITING
Septic Shock
Northern Jiangsu People's Hospital
 2026-03-02 PHASE4
NCT04231708 NOT_YET_RECRUITING
Opioid Use Disorder
Wayne State University
 2026-10 PHASE2
NCT07498465 WITHDRAWN
Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia; Childhood Mixed Phenotype Acute Leukemia; Mixed Phenotype Acute Leukemia
Children's Oncology Group
 2026-09-10 PHASE1
NCT07796997 NOT_YET_RECRUITING
Pancreatic Cancer; Pancreatic Adenocarcinoma; Duodenal Cancer; Distal Cholangiocarcinoma
University of Illinois at Chicago
 2026-09 PHASE1
NCT05008146 RECRUITING
Cocaine Use Disorder
Rajesh Narendran
 2020-12-31 EARLY_PHASE1
NCT06381661 RECRUITING
Sepsis
Assistance Publique - Hôpitaux de Paris
 2026-07-09 PHASE2
NCT06136624 RECRUITING
Prostate Cancer Metastatic
Merck Sharp & Dohme LLC
 2023-12-31 PHASE3
NCT04546399 RECRUITING
Down Syndrome; Recurrent B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2020-12-17 PHASE2
NCT06136650 RECRUITING
Metastatic Castration-resistant Prostate Cancer (mCRPC); Prostatic Neoplasms
Merck Sharp & Dohme LLC
 2023-12-18 PHASE3
NCT05761171 ACTIVE_NOT_RECRUITING
Recurrent Acute Leukemia of Ambiguous Lineage; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia; Recurrent Mixed Phenotype Acute Leukemia; Refractory Acute Leukemia of Ambiguous Lineage; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage; Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged; Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia; Refractory Mixed Phenotype Acute Leukemia
Children's Oncology Group
 2024-01-08 PHASE2
NCT07262957 RECRUITING
Pancreas Head Cancer; Pancreas Adenocarcinoma; IPMN, Pancreatic; Cholangio Carcinoma; Ampulla of Vater Adenocarcinoma; PDAC - Pancreatic Ductal Adenocarcinoma; Duodenal Carcinoma; Mucinous Cystic Neoplasm; Neuro Endocrine Tumours; Pancreatitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2025-09-01 PHASE4
NCT04082533 ACTIVE_NOT_RECRUITING
Pain; Arthrofibrosis; Osteoarthritis, Knee
Hospital for Special Surgery, New York
 2019-07-24 PHASE4
NCT06895473 RECRUITING
Hematopoietic and Lymphatic System Neoplasm
OHSU Knight Cancer Institute
 2025-06-04 PHASE2
NCT05160506 RECRUITING
Pancreatitis; Pancreatitis, Acute; Corticosteroid; Hydrocortisone
Beth Israel Deaconess Medical Center
 2022-03-06 PHASE2
NCT03760835 RECRUITING
Congenital Adrenal Hyperplasia
Federico II University
 2016-08-11 PHASE4
NCT03020030 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia, Pediatric
Dana-Farber Cancer Institute
 2017-03-03 PHASE3
NCT03401398 RECRUITING
Septic Shock
Jerry Zimmerman
 2019-03-11 PHASE3
NCT06982183 RECRUITING
Fear of Spiders; Acute Stress Reaction
Walter Reed Army Institute of Research (WRAIR)
 2025-05-27 PHASE4
NCT07695337 COMPLETED
Septic Shock
Benha University
 2026-01-01 PHASE4
NCT05435781 RECRUITING
Adrenal Insufficiency; Polymyalgia Rheumatica; Giant Cell Arteritis
Marianne Christina Klose
 2022-06-07 PHASE4
NCT07248761 ACTIVE_NOT_RECRUITING
Shock; Preterm Birth Complication; Preterm Intraventricular Hemorrhage; Asphyxia Perinatal; Distress Respiratory Syndrome; Hyperglycaemia (Non Diabetic); Neonatal Sepsis, Early-Onset; Neonatal Sepsis, Late-Onset; NEC - Necrotizing Enterocolitis; Patent Ductus Arteriosus in Preterm Infants; Intestinal Perforation
Coordinación de Investigación en Salud, Mexico
 2025-02-01 PHASE4
NCT06136598 COMPLETED
Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer
Merck Sharp & Dohme LLC
 2024-01-30 PHASE1
NCT06556277 COMPLETED
Glucocorticoids; Overweight and Obesity; Overeating
Eleonora Seelig
 2024-09-01
NCT02735707 RECRUITING
Community-acquired Pneumonia, Influenza, COVID-19
UMC Utrecht
 2016-04-11 PHASE3
NCT04404400 RECRUITING
Critical Illness Related Corticosteroids Insufficiency
Assistance Publique - Hôpitaux de Paris
 2022-02-17 PHASE3
NCT06217939 TERMINATED
Sepsis Severe; Shock, Septic
Siriraj Hospital
 2024-06-25
NCT05193396 RECRUITING
Adrenal Insufficiency; Polymyalgia Rheumatica (PMR); Giant Cell Arteritis (GCA)
Marianne Andersen
 2022-02-01 PHASE4
NCT03548246 WITHDRAWN
Congenital Adrenal Hyperplasia
University of Texas Southwestern Medical Center
 2023-01 PHASE2
NCT06679816 RECRUITING
Pituitary Adenoma; Pituitary Neuroendocrine Tumor
Beijing Tiantan Hospital
 2024-12-04 PHASE4
NCT06723626 RECRUITING
Septic Shock
Southeast University, China
 2024-07-01
NCT03913559 TERMINATED
Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
 2019-05-14 PHASE2
NCT06435481 NOT_YET_RECRUITING
Adrenal Insufficiency
Hospital Universitari Vall d'Hebron Research Institute
 2024-09 PHASE4
NCT04924166 COMPLETED
PTSD; Acute Stress Disorder; Trauma-related Stressor
Rachel Yehuda
 2022-01-12 PHASE2
NCT06018727 WITHDRAWN
Borderline Personality Disorder
University of North Carolina, Chapel Hill
 2024-07 PHASE4
NCT02691858 UNKNOWN
Intussusception
Cairo University
 2015-04
NCT05436535 COMPLETED
Atopic Dermatitis
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-11-21 PHASE4
NCT06496997 COMPLETED
Acute Respiratory Distress Syndrome
Fayoum University
 2024-08-01 PHASE2; PHASE3
NCT06930456 ENROLLING_BY_INVITATION
Post Spinal Anaesthesia Hypotension
Nada kamel Elgamal
 2024-03-01
NCT07792512 COMPLETED
Oral Lichen Planus; Tumor Necrosis Factor-alpha
Ain Shams University
 2022-01-20 PHASE4
NCT03936517 UNKNOWN
Adrenal Insufficiency
Imperial College London
 2019-07-31 PHASE3
NCT05073172 WITHDRAWN
Breast Carcinoma; Head and Neck Carcinoma; Radiation-Induced Dermatitis
OHSU Knight Cancer Institute
 2024-01-01
NCT06488742 UNKNOWN
Dermatitis, Atopic; Pruritus
Nexgen Dermatologics, Inc.
 2023-11-01
NCT05919992 COMPLETED
Glucocorticoid Effect
Eleonora Seelig
 2023-05-15 EARLY_PHASE1
NCT03832010 COMPLETED
Atopic Dermatitis; Eczema
Johns Hopkins University
 2019-12-17 PHASE4
NCT05165875 UNKNOWN
De Quervain Syndrome
National University Hospital, Singapore
 2022-06
NCT03817320 ACTIVE_NOT_RECRUITING
ALL, Childhood; Lymphoblastic Lymphoma, Childhood; Lymphoblastic Leukemia, Acute, Childhood
Therapeutic Advances in Childhood Leukemia Consortium
 2019-02-12 PHASE1; PHASE2
NCT05222152 COMPLETED
Primary Adrenal Insufficiency
Neurocrine UK Limited
 2021-11-23 PHASE2
NCT05320380 WITHDRAWN
Recurrent Acute Myeloid Leukemia; Recurrent B Acute Lymphoblastic Leukemia; Recurrent Mixed Phenotype Acute Leukemia; Recurrent T Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory B Acute Lymphoblastic Leukemia; Refractory Mixed Phenotype Acute Leukemia; Refractory T Acute Lymphoblastic Leukemia
Children's Oncology Group
 2023-08-01 PHASE1; PHASE2
NCT05919121 UNKNOWN
Impingement Syndrome; Subacromial Impingement Syndrome
Horus University
 2023-05-01
NCT05674253 UNKNOWN
Atrial Fibrillation New Onset
Ain Shams University
 2022-12-25 EARLY_PHASE1
NCT05167084 COMPLETED
Glucocorticoid Effect
Eleonora Seelig
 2022-02-08 EARLY_PHASE1
NCT04180969 WITHDRAWN
Stress; Healthy
Wayne State University
 2023-04-10 PHASE2
NCT04181515 WITHDRAWN
Stress; Opioid-use Disorder
Wayne State University
 2023-04-10 PHASE2
NCT03773822 COMPLETED
Cardiogenic Shock
CMC Ambroise Paré
 2019-04-19 PHASE3
NCT03592693 TERMINATED
Shock, Septic
University of Athens
 2018-09-06 PHASE2
NCT03649633 TERMINATED
Septic Shock
University of Athens
 2018-09-06 PHASE1; PHASE2
NCT05741762 Active not recruiting
Critical Illness|Adrenal Insufficiency|Septic Shock
Dr Adnan Agha|United Arab Emirates University
 2023-01-31 --
NCT03682393 WITHDRAWN
Atrial Fibrillation
Kuopio University Hospital
 2020-01-01 PHASE2; PHASE3
NCT04852458 COMPLETED
Traumatic Birth
University of Michigan
 2021-05-21 PHASE1
NCT02229136 COMPLETED
Stomatitis; Oral Mucositis; Neoplasm of the Breast; Malignant Tumor of Breast
US Oncology Research
 2014-09-04 PHASE2
NCT05607901 Recruiting
Dermatologic Disease
Tanta University
 2022-10-28 Phase 2
NCT04536662 UNKNOWN
Congenital Adrenal Hyperplasia
Shanghai Jiao Tong University School of Medicine
 2020-10-01 PHASE4
NCT04037605 ACTIVE_NOT_RECRUITING
Sleep Restriction
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2020-02-09 EARLY_PHASE1
NCT05192213 TERMINATED
Sepsis; Septic Shock
Hospital Sirio-Libanes
 2021-08-01 PHASE3
NCT03062280 COMPLETED
Congenital Adrenal Hyperplasia
Neurocrine UK Limited
 2016-08-18 PHASE3
NCT05324618 Completed
Atopic|Dermatitis
Ain Shams University|National Hepatology & Tropical Medicine Research Institute
 2022-05-15 Phase 4
NCT02043587 TERMINATED
Acute Lymphocytic Leukemia; Adult Lymphoblastic Lymphoma
University of California, San Diego
 2014-01 PHASE2
NCT04896489 COMPLETED
Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory
Yale University
 2021-05-12 EARLY_PHASE1
NCT00859781 ACTIVE_NOT_RECRUITING
Prostate Cancer
Weill Medical College of Cornell University
 2009-06 PHASE2
NCT04359147 COMPLETED
Yohimbine; Hydrocortisone; Yohimbine + Hydrocortisone; Placebo
Charite University, Berlin, Germany
 2019-11-01
NCT03813147 COMPLETED
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2019-05-17 PHASE1
NCT03872011 COMPLETED
Septic Shock
Northern Jiangsu People's Hospital
 2019-02-19 PHASE3
NCT03349281 COMPLETED
Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia
Julio Barredo, MD
 2019-03-25 PHASE1
NCT03792256 COMPLETED
Leukemia, Lymphocytic; Lymphoblastic Lymphoma; T-cell Lymphoma; T-cell Leukemia; Recurrent Disease; Acute Leukemia
Children's Oncology Group
 2019-04-11 PHASE1
NCT03335774 COMPLETED
Internal Hemorrhoids
Nivagen Pharmaceuticals Inc.
 2019-02-12 PHASE2
NCT04301479 UNKNOWN
Vasoplegia; Cardiac Surgery
Instituto do Coracao
 2020-03 PHASE3
NCT05276323 COMPLETED
Atopic Dermatitis
Soroka University Medical Center
 2020-10-01 PHASE2
NCT03766997 UNKNOWN
Granulomatous Mastitis
Peking Union Medical College Hospital
 2019-02-19 PHASE4
NCT02602210 TERMINATED
Liver Cirrhosis
Universitaire Ziekenhuizen KU Leuven
 2015-01 PHASE3
NCT04508946 COMPLETED
Septic Shock; Sepsis; Organ Dysfunction Syndrome Sepsis
Air Force Specialized Hospital, Cairo, Egypt
 2019-08-01 PHASE3
NCT03142893 ACTIVE_NOT_RECRUITING
Sleep Restriction
Peter y. Liu
 2017-05-08 PHASE1
NCT01095172 UNKNOWN
Function of Renal Transplant
Guy's and St Thomas' NHS Foundation Trust
 2010-11 PHASE4
NCT02828358 COMPLETED
Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia
National Cancer Institute (NCI)
 2017-04-01 PHASE2
NCT04325490 COMPLETED
Intertrigo
Mahidol University
 2019-10-01 PHASE4
NCT02481310 UNKNOWN
Adult Burkitt Lymphoma; B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma; MYC Gene Mutation; Plasmablastic Lymphoma
Northwestern University
 2015-10-28 PHASE1; PHASE2
NCT01353313 COMPLETED
Infant, Newborn; Infant, Small for Gestational Age; Infant, Very Low Birth Weight; Infant, Premature; Bronchopulmonary Dysplasia
NICHD Neonatal Research Network
 2011-08-11 PHASE3
NCT04197115 COMPLETED
Sepsis; Septic Shock
IMSS Hospital General de Zona 11, Piedras Negras
 2019-09-01 PHASE3
NCT01265017 WITHDRAWN
Type 1 Diabetes
Sansum Diabetes Research Institute
 2012-07 PHASE1
NCT04435912 COMPLETED
Blood Pressure; Heart Rate; Airway Pressure
University of Jordan
 2019-07-04 EARLY_PHASE1
NCT04536129 COMPLETED
Ocular Surface Disease; Glaucoma
University of Molise
 2019-11-04
NCT03540628 COMPLETED
Septic Shock
Corewell Health South
 2018-02-26
NCT04137302 COMPLETED
Anti-doping Campaign, Detection of Hydrocortisone
Centre Hospitalier Régional d'Orléans
 2019-11-13 PHASE4
NCT03821714 COMPLETED
Septic Shock
Southeast University, China
 2019-02-01
NCT03371784 UNKNOWN
ST-segment Elevation Myocardial Infarction; Left Ventricular Remodeling
Iuliu Hatieganu University of Medicine and Pharmacy
 2018-03-08 PHASE2; PHASE3
NCT02837432 COMPLETED
Depression
Stanford University
 2016-07 EARLY_PHASE1
NCT01817153 TERMINATED
Septic Shock; Adult
Centre Hospitalier Régional d'Orléans
 2013-11-05 PHASE2; PHASE3
NCT03380507 TERMINATED
Septic Shock; Critical Illness
Hamad Medical Corporation
 2018-03-17 PHASE2; PHASE3
NCT03845608 UNKNOWN
Laparoscopic Gynecological Surgery
Cairo University
 2019-03 PHASE4
NCT02116608 COMPLETED
Granuloma; Tracheostomy
University of Colorado, Denver
 2014-09 PHASE4
NCT03282487 UNKNOWN
Adrenal Insufficiency
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
 2017-09-05 PHASE4
NCT03509350 COMPLETED
Sepsis
Emory University
 2018-08-22 PHASE3
NCT03333278 COMPLETED
Shock, Septic; Critically Ill; Vasoplegic Syndrome; Sepsis
Australian and New Zealand Intensive Care Research Centre
 2018-05-02 PHASE2
NCT03910088 COMPLETED
Post-Dural Puncture Headache
Cairo University
 2019-04-20 PHASE4
NCT03422159 COMPLETED
Sepsis, Severe; Septic Shock
Community Medical Center, Toms River, NJ
 2018-02-05 PHASE2
NCT03071276 TERMINATED
Acute Myeloid Leukemia (AML)
St. Jude Children's Research Hospital
 2016-01-14 PHASE2
NCT02473263 COMPLETED
Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
Assistance Publique - Hôpitaux de Paris
 2016-05-09 PHASE3
NCT03258684 COMPLETED
Sepsis
Zhujiang Hospital
 2017-09-25
NCT02775227 ACTIVE_NOT_RECRUITING
Pancreatic Fistula; Pancreatic Neoplasms
Helsinki University Central Hospital
 2016-05 PHASE4
NCT03358082 UNKNOWN
Vitiligo; Tacrolimus
Sohag University
 2017-10-01 PHASE1; PHASE2
NCT03649009 UNKNOWN
Hyperlactatemia
Universiti Kebangsaan Malaysia Medical Centre
 2018-01-01
NCT03335124 TERMINATED
Sepsis; Septic Shock; Critical Illness; Fluid Overload
University Medical Centre Ljubljana
 2017-09-26 PHASE4
NCT03907865 COMPLETED
Dry Eye
Medical University of Vienna
 2018-03-27 PHASE4
NCT03758365 COMPLETED
Vasoconstriction
MC2 Therapeutics
 2018-11-05 PHASE1
NCT03465007 COMPLETED
Dialysis Hypotension
University of Jordan
 2017-10-22
NCT01874860 COMPLETED
Colorectal Cancer; Head and Neck Cancer
University of Louisville
 2013-08 PHASE2
NCT03585829 COMPLETED
Corticotropin Deficiency; Fasting
University Tunis El Manar
 2018-05-17 PHASE4
NCT02790788 COMPLETED
Inhospital Cardiac Arrest
University of Athens
 2016-11-04 PHASE1; PHASE2
NCT03343327 COMPLETED
Adrenal Insufficiency
Neurocrine UK Limited
 2018-02-19 PHASE1
NCT03261336 TERMINATED
Castration-resistant Prostate Cancer
Donald Trump, MD
 2017-01-06 PHASE2
NCT03179813 COMPLETED
Impacted Third Molar Tooth
University of Sao Paulo
 2017-05-01 PHASE4
NCT03110198 UNKNOWN
Ulcerative Colitis, Unspecified
Xijing Hospital of Digestive Diseases
 2017-05 PHASE4
NCT02112019 UNKNOWN
Sjögren's Syndrome
Derk Jan Jager
 2014-06
NCT02700828 COMPLETED
Hypoxic-Ischemic Encephalopathy; Asphyxia
Semmelweis University
 2016-02 PHASE2; PHASE3
NCT01448109 COMPLETED
Septic Shock
The George Institute
 2012-06-13 PHASE4
NCT02722200 COMPLETED
Obesity
Yale University
 2016-05 PHASE1
NCT02535806 TERMINATED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Children's Mercy Hospital Kansas City
 2015-07 PHASE2
NCT02266264 COMPLETED
Hyperglycemia
Srinakharinwirot University
 2014-10 PHASE4
NCT01771328 UNKNOWN
Adrenal Hyperplasia, Congenital
Haukeland University Hospital
 2013-02 PHASE2
NCT02289989 TERMINATED
Atopic Dermatitis
Rutgers, The State University of New Jersey
 2014-11
NCT01859312 COMPLETED
Adrenal Insufficiency; Excess Androgen; Congenital Adrenal Hyperplasia (CAH)
National Institutes of Health Clinical Center (CC)
 2013-05-06 PHASE2
NCT02360046 TERMINATED
Hypopituitarism; Hydrocortisone; Lipids; Fatty Acids, Nonesterified; Insulin Sensitivity
Insel Gruppe AG, University Hospital Bern
 2015-01
NCT02084134 COMPLETED
Pituitary Adenoma; Pituitary Diseases
Washington University School of Medicine
 2012-03
NCT02270788 COMPLETED
Acute Myeloid Leukemia
St. Jude Children's Research Hospital
 2015-04-02 PHASE1
NCT00536991 TERMINATED
Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer
Roswell Park Cancer Institute
 2006-10 PHASE1; PHASE2
NCT00855270 UNKNOWN
Post Traumatic Stress Disorder
Sheba Medical Center
 2009-04
NCT02580240 COMPLETED
Septic Shock
Northern Jiangsu People's Hospital
 2015-09
NCT02277587 COMPLETED
Primary Adrenal Insufficiency; Secondary Adrenal Insufficiency
University of Roma La Sapienza
 2014-03 PHASE4
NCT02044159 COMPLETED
Shock
Children's Hospital of Eastern Ontario
 2014-07 PHASE4
NCT02212561 COMPLETED
Acute Myeloid Leukemia (AML); Acute Lymphoblastic Leukemia (ALL); Myelodysplastic Syndrome (MDS); Mixed Phenotype Acute Leukemia (MPAL)
St. Jude Children's Research Hospital
 2014-08 PHASE1
NCT02760862 COMPLETED
Headache
Ain Shams University
 2014-10 PHASE4
NCT02689856 COMPLETED
Hemorrhoids
Citius Pharmaceuticals, Inc.
 2015-05 PHASE2
NCT02756546 COMPLETED
Systemic Lupus Erythematosis
Cairo University
 2014-09 PHASE1; PHASE2
NCT00674570 COMPLETED
Stress Disorders, Posttraumatic
VA Office of Research and Development
 2009-01-13 PHASE4
NCT00625209 COMPLETED
Septic Shock
University of Versailles
 2008-03 PHASE3
NCT02408068 COMPLETED
Healthy
Neurocrine UK Limited
 2015-01 PHASE1
NCT00980876 COMPLETED
Otitis Externa
Farmoquimica S.A.
 2012-04 PHASE3
NCT00895310 COMPLETED
Prostate Cancer
University of California, Davis
 2009-05 PHASE2
NCT01284452 COMPLETED
Septic Shock; Severe Sepsis; Acute Lung Injury; Acute Respiratory Distress Syndrome
Mahidol University
 2010-12
NCT01960530 COMPLETED
Adrenal Insufficiency
Neurocrine UK Limited
 2013-10 PHASE1
NCT00873093 COMPLETED
B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2009-03 PHASE2
NCT00400946 COMPLETED
Drug/Agent Toxicity by Tissue/Organ; Leukemia
Dana-Farber Cancer Institute
 2005-04 PHASE3
NCT02190994 UNKNOWN
Pituitary Neoplasms; Craniopharyngiomas
West China Hospital
 2013-08 PHASE4
NCT00676585 COMPLETED
Cardiac Arrest
Beth Israel Deaconess Medical Center
 2007-10 PHASE1; PHASE2
NCT01691209 WITHDRAWN
Dermatitis, Atopic
Bayer
 2013-10
NCT01913158 COMPLETED
Internal Hemorrhoids
G & W Laboratories Inc.
 2013-10 PHASE2
NCT01847690 UNKNOWN
Addison Disease
Haukeland University Hospital
 2013-06 PHASE2
NCT01782859 COMPLETED
Total Hip Replacement
Hospital for Special Surgery, New York
 2012-10
NCT01735617 COMPLETED
Endocrine Disease; Adrenal Insufficiency; Congenital Adrenal Hyperplasia
Neurocrine UK Limited
 2012-12 PHASE2
NCT01090518 UNKNOWN
PTSD
Bronx VA Medical Center
 2010-02
NCT01595386 COMPLETED
Heart Disease Congenital Complex
University of Alabama at Birmingham
 2012-04
NCT02266589 COMPLETED
Septic Shock; Sepsis
Nanjing PLA General Hospital
 2011-11 PHASE3
NCT00096135 COMPLETED
Leukemia
Children's Oncology Group
 2004-11
NCT02889224 COMPLETED
Cushing's Syndrome
University Hospital, Bordeaux
 2012-02
NCT00476190 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
 2007-04 PHASE2
NCT01546922 COMPLETED
Adrenal Insufficiency
University Medical Center Groningen
 2012-02 PHASE4
NCT00953576 TERMINATED
Prostate Cancer
Dana-Farber Cancer Institute
 2009-09-29 PHASE1; PHASE2
NCT01064622 COMPLETED
Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC v6 and v7
National Cancer Institute (NCI)
 2009-09-03 PHASE2
NCT01063569 COMPLETED
Addison's Disease
Haukeland University Hospital
 2010-02 PHASE2; PHASE3
NCT01064986 COMPLETED
Infections
Rutgers, The State University of New Jersey
 2010-02 PHASE1
NCT01574612 COMPLETED
Herpes Labialis
Meda Pharmaceuticals
 2012-03 PHASE3
NCT00473083 COMPLETED
Rash
British Columbia Cancer Agency
 2009-01 PHASE2
NCT00853008 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
 2003-01 PHASE4
NCT02114710 COMPLETED
Coagulation Dysfunction in Septic Shock; Hemodynamic Improvement Induced by Hydrocortisone
Nanjing PLA General Hospital
 2009-05 PHASE3
NCT00442494 TERMINATED
Atrial Fibrillation
Kuopio University Hospital
 2012-10
NCT01267266 TERMINATED
Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
 2010-12 PHASE2
NCT01450930 COMPLETED
Primary Adrenal Insufficiency
Bruno Allolio
 2011-11 PHASE2
NCT01815918 COMPLETED
Total Knee Arthroplasty
Hospital for Special Surgery, New York
 2011-02 PHASE4
NCT01574014 TERMINATED
Phobic Disorders; Phobias
Insel Gruppe AG, University Hospital Bern
 2009-07 PHASE2
NCT00706173 WITHDRAWN
Post-traumatic Stress Disorder
University of California, San Diego
 2009-08 PHASE4
NCT00133991 COMPLETED
Leukemia; Lymphoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2005-07 PHASE2
NCT00675272 TERMINATED
Brain Death
Kuopio University Hospital
 2008-05
NCT01014364 TERMINATED
Pneumonia, Viral; Influenza in Humans
University of Versailles
 2010-03 PHASE3
NCT00131053 UNKNOWN
Lymphoblastic Leukemia, Acute
Japan Adult Leukemia Study Group
 2002-09 PHASE2
NCT00751855 COMPLETED
PTSD
VISN 3 Mental Illness Research, Education and Clinical Center
 2008-07
NCT00874393 COMPLETED
Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Hypotension; Blood Pressure
NICHD Neonatal Research Network
 2009-07 PHASE1
NCT00186628 COMPLETED
Leukemia, Mast-Cell; Mantle-cell Lymphoma
Stanford University
 2005-06 PHASE2
NCT00334672 UNKNOWN
Nonneoplastic Condition
Children's Cancer and Leukaemia Group
 2006-03 PHASE3
NCT00460031 COMPLETED
Prostate Cancer
Case Comprehensive Cancer Center
 2006-09-01 PHASE2
NCT01070225 COMPLETED
Asthma
University of Dundee
 2010-03 PHASE4
NCT01399268 COMPLETED
Postoperative Inflammatory Response
Hospital for Special Surgery, New York
 2009-02 PHASE4
NCT01150409 TERMINATED
Septic Shock
The Cleveland Clinic
 2008-05 PHASE4
NCT00862381 COMPLETED
Patient Admitted in Reanimation
University Hospital, Grenoble
 2008-10 PHASE3
NCT01007591 COMPLETED
Psoriasis Vulgaris
LEO Pharma
 2009-10 PHASE3
NCT01055249 COMPLETED
Pain; Inflammation; Healthy Volunteers
X-pert Med GmbH
 2010-01 PHASE1
NCT00358748 COMPLETED
Neonatal Hypotension
University of British Columbia
 2005-07 PHASE3
NCT02768740 COMPLETED
Septic Shock
Association Niçoise de Réanimation Médicale
 2008-04 PHASE4
NCT00691002 COMPLETED
Psoriasis Vulgaris
LEO Pharma
 2008-05 PHASE3
NCT00354107 TERMINATED
Anaplastic Large Cell Lymphoma; Recurrent Childhood Anaplastic Large Cell Lymphoma
National Cancer Institute (NCI)
 2007-01 PHASE1; PHASE2
NCT00415701 COMPLETED
Coronary Artery Disease; Mitral Valve Regurgitation
Insel Gruppe AG, University Hospital Bern
 2006-11 PHASE4
NCT00590018 COMPLETED
Cardiac Output, Low
Baylor College of Medicine
 2003-02 PHASE2
NCT00704262 COMPLETED
Psoriasis Vulgaris
LEO Pharma
 2008-05 PHASE2
NCT00057811 COMPLETED
Childhood Burkitt Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Stage I Childhood Large Cell Lymphoma; Stage I Childhood Small Noncleaved Cell Lymphoma; Stage II Childhood Large Cell Lymphoma; Stage II Childhood Small Noncleaved Cell Lymphoma; Stage III Childhood Large Cell Lymphoma; Stage III Childhood Small Noncleaved Cell Lymphoma; Stage IV Childhood Large Cell Lymphoma; Stage IV Childhood Small Noncleaved Cell Lymphoma; Untreated Childhood Acute Lymphoblastic Leukemia
Children's Oncology Group
 2004-06 PHASE2
NCT00805285 TERMINATED
Inflammatory Bowel Disease; Ulcerative Colitis
University of Maryland, Baltimore
 2008-10 PHASE2
NCT00623766 COMPLETED
Melanoma
Bristol-Myers Squibb
 2008-07 PHASE2
NCT00597857 UNKNOWN
Posttraumatic Stress Disorder
Kent State University
 2005-06
NCT00591006 COMPLETED
Healthy
University of Texas Southwestern Medical Center
 2008-01 PHASE3
NCT00368381 WITHDRAWN
Sepsis; Adrenal Insufficiency
CAMC Health System
 2006-09 PHASE4
NCT00705822 TERMINATED
Prostatic Neoplasms
Sanofi
 2006-08 PHASE3
NCT00640822 COMPLETED
Psoriasis Vulgaris
LEO Pharma
 2008-02 PHASE3
NCT01769339 COMPLETED
Vulva; Candidiasis
Janssen Pharmaceutica
 2009-01 PHASE4
NCT00507832 COMPLETED
Prurigo Nodularis
University Hospital Muenster
 2007-04 PHASE2
NCT00773058 UNKNOWN
Acute Respiratory Distress Syndrome; Adrenal Insufficiency
Southeast University, China
 2008-12 PHASE4
NCT00542841 COMPLETED
21-hydroxylase Deficiency
Maria I. New
 2007-08
NCT00167544 COMPLETED
Bronchopulmonary Dysplasia; Encephalomalacia; Premature Birth
Nationwide Children's Hospital
 2005-11 PHASE2
NCT00618501 COMPLETED
Leukemia
Asan Medical Center
 2005-10 PHASE2
NCT00136435 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
 2002-06 PHASE2
NCT00709839 COMPLETED
Healthy
Medical University of Vienna
 2008-06 PHASE4
NCT00176462 COMPLETED
Acute Lymphocytic Leukemia
Rutgers, The State University of New Jersey
 2001-02 PHASE2
NCT00559481 WITHDRAWN
Prostate Cancer
Roswell Park Cancer Institute
 2007-10
NCT00915343 COMPLETED
Adrenal Insufficiency
Shire
 2007-08-21 PHASE2; PHASE3
NCT00003728 UNKNOWN
Leukemia; Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 1998-12 PHASE3
NCT00754247 COMPLETED
Keloid; Hypertrophic Scar; Cicatrix, Hypertrophic
University of Miami
 2006-03 PHASE4
NCT00396344 COMPLETED
Sepsis
Dartmouth-Hitchcock Medical Center
 2006-10
NCT00309894 COMPLETED
Prostate Cancer
University of California, San Francisco
 2004-04 PHASE2
NCT00003593 COMPLETED
Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
Children's Oncology Group
 1999-06 PHASE3
NCT00002744 COMPLETED
Leukemia
Children's Oncology Group
 1996-05 PHASE3
NCT00563303 COMPLETED
Polytraumatism
Nantes University Hospital
 2006-11 PHASE2; PHASE3
NCT00002798 COMPLETED
Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myelomonocytic Leukemia (M4); Childhood Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Refractory Anemia With Ringed Sideroblasts; Secondary Myelodysplastic Syndromes; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
National Cancer Institute (NCI)
 1996-08 PHASE3
NCT00049569 COMPLETED
L1 Childhood Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Non-T, Non-B Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2003-01
NCT00097474 COMPLETED
Jet Lag
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2004-12-21 PHASE2
NCT00451230 COMPLETED
Cocaine Dependence
National Institute on Drug Abuse (NIDA)
 2005-06
NCT00002855 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
 1996-08 PHASE3
NCT00005802 COMPLETED
Leukemia
Fred Hutchinson Cancer Center
 1999-06 PHASE1; PHASE2
NCT00002970 COMPLETED
Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma; T-cell Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 1997-06 PHASE2
NCT00027859 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
 2003-10-08 PHASE3
NCT00688987 COMPLETED
Obesity; Addison's Disease
Oregon Health and Science University
 2000-08
NCT00002704 COMPLETED
Leukemia
National Cancer Institute (NCI)
 1996-01 PHASE2
NCT00002494 COMPLETED
Leukemia; Lymphoma
Alliance for Clinical Trials in Oncology
 1992-05 PHASE2
NCT00002700 COMPLETED
Leukemia; Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 1995-08 PHASE3
NCT00002921 TERMINATED
Adrenocortical Carcinoma
SWOG Cancer Research Network
 1997-03 PHASE2
NCT00002757 COMPLETED
Leukemia; Lymphoma
Children's Oncology Group
 2001-06 PHASE3
NCT01453686 COMPLETED
Alopecia Areata
The Hospital for Sick Children
 2002-08 PHASE3
NCT00002471 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
 1990-02 PHASE2
NCT00002816 COMPLETED
Leukemia
Children's Oncology Group
 1996-12 PHASE3
NCT00002552 COMPLETED
Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
Barbara Ann Karmanos Cancer Institute
 1993-10 PHASE2
NCT00002805 COMPLETED
Leukemia
Children's Oncology Group
 1997-08 PHASE2
NCT00002785 COMPLETED
Leukemia
Children's Oncology Group
 1996-07 PHASE2
NCT00002865 COMPLETED
Leukemia
Wake Forest University Health Sciences
 1995-04 PHASE2
NCT00002881 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
 1996-10 PHASE3
NCT00004669 COMPLETED
Bronchopulmonary Dysplasia
National Center for Research Resources (NCRR)
 1996-06 PHASE2
NCT01047670 UNKNOWN
Mechanical Ventilation; Mortality
Unidade de Terapia Intensiva
 2008-05 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydrocortisone acts as a glucocorticoid receptor agonist that binds cytosolic glucocorticoid receptors, inducing translocation to the nucleus where it modulates transcription of inflammatory mediators and metabolic genes. This signaling cascade leads to reduced pro-inflammatory cytokine expression and enhanced gluconeogenesis, providing clinical utility in mitigating systemic inflammatory responses in septic shock and replenishing hormonal deficit in adrenal insufficiency.

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.