Cortef

(Hydrocortisone)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Hydrocortisone is a steroid medication used to reduce inflammation and suppress the immune system to treat conditions like allergies, asthma, arthritis, and adrenal insufficiency. It can also be used to treat skin conditions, severe infections, and to replace hormones in people whose bodies don't produce enough naturally.[2] Cortef is currently approved and in use across 98 indications[4].[1]

Cortef is one of 1489 small molecule programs targeting Exanthem. It is currently in Approved.

Indications

203

Total Trials

Active Trials

1,488

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ExanthemActive, not recruiting

HIV InfectionApproved

ColitisActive, not recruiting

Cirrhosis of LiverApproved

Herpes Simplex InfectionActive, not recruiting

Primary Adrenal InsufficiencyApproved

Cardiac ArrestActive, not recruiting

Adult Acute Lymphoblastic LeukemiaActive, not recruiting

Prostate AdenocarcinomaApproved

LipomatosisActive, not recruiting

ExanthemApproved

Active, not recruiting

HIV InfectionApproved

Approved

ColitisApproved

Active, not recruiting

Cirrhosis of LiverApproved

Approved

Herpes Simplex InfectionApproved

Active, not recruiting

Primary Adrenal InsufficiencyApproved

Approved

Cardiac ArrestPhase 1

Active, not recruiting

Adult Acute Lymphoblastic LeukemiaApproved

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

LipomatosisPhase 3

Active, not recruiting

Showing 10 of 94 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 2

Tykerb

GSK

Preclinical

80 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

2 9

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 10

Citalopram Hydrobromide

TTorrent Pharmaceuticals Limited

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Treatment

NCT05668455

Post-ApprovalRecruiting

Hydrocortisone

NCT06982183

Phase 1Recruiting

Stress

NCT06430580

Q1 2027

N/ARecruiting

Pneumonia

NCT05354778

Q2 2027

Phase 2Recruiting

Pancreatitis

NCT05160506

Q3 2027

Post-ApprovalRecruiting

Hypothermia

NCT05836610

Clinical

Trials by Indication[1]

Hydrocortisone16 trials

Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

Terminated·RRennes University Hospital·Phase 1/2·NCT00673270·13 enrolled

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration

Completed·UUniversity of Texas at Austin··NCT01710202·120 enrolled

Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

Completed·SStanford University·N/A·NCT00186264·18 enrolled

Show 13 more trials

Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction

Withdrawn·UUniversity of Virginia·Phase 1·NCT01422733

An Investigational Study of Hydrocortisone

Completed·NNeurocrine UK Limited·Phase 1·NCT01960530·14 enrolled

Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Completed·UUniversity Tunis El Manar·Phase 4·NCT05457296·40 enrolled

Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone

Completed·UUniversity Tunis El Manar·Phase 4·NCT03585829·53 enrolled

Organ Donation and Hydrocortisone Treatment

Terminated·KKuopio University Hospital·N/A·NCT00675272·38 enrolled

The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers

Completed·RRutgers, The State University of New Jersey·Phase 1·NCT01064986·12 enrolled

Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

Completed·NNationwide Children's Hospital·Phase 2·NCT00167544·64 enrolled

An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

Completed·NNeurocrine UK Limited·Phase 1·NCT03019614·30 enrolled

Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone

Completed·XX-pert Med GmbH·Phase 1·NCT01301677·47 enrolled

Hydrocortisone for BPD

Completed·NNICHD Neonatal Research Network·Phase 3·NCT01353313·800 enrolled

PTSD Prevention Using Oral Hydrocortisone

Completed·RRachel Yehuda·Phase 2·NCT04924166·201 enrolled

The Effects of Propranolol, Hydrocortisone, and Morphine on Military-Relevant Performance Outcomes

Recruiting·WWalter Reed Army Institute of Research (WRAIR)·Phase 4·NCT06982183·110 enrolled

Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

Completed·NNeurocrine UK Limited·Phase 1·NCT02777268·16 enrolled

Septic Shock14 trials

Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock

Terminated·TThe Cleveland Clinic·Phase 4·NCT01150409·11 enrolled

Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02473263·398 enrolled

Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Completed·NNanjing PLA General Hospital·Phase 3·NCT02114710·240 enrolled

Show 11 more trials

HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients

Completed·UUniversity of Tennessee Medical Center·Phase 2·NCT03710187·84 enrolled

Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

Unknown status·UUniversiti Kebangsaan Malaysia Medical Centre·N/A·NCT03649009·72 enrolled

The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

Terminated·UUniversity Medical Centre Ljubljana·Phase 4·NCT03335124·5 enrolled

Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults

Completed·—·Phase 4·NCT04492280·66 enrolled

Septic Shock em Steroids

Unknown status·UUnidade de Terapia Intensiva·Phase 2/3·NCT01047670·160 enrolled

Hydrocortisone for Prevention of Septic Shock

Completed·—·Phase 3·NCT00670254·380 enrolled

Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock

Completed·NNanjing PLA General Hospital·Phase 3·NCT02266589·84 enrolled

ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock

Completed·TThe George Institute·Phase 4·NCT01448109·3,800 enrolled

The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial

Completed·—·Phase 2·NCT03333278·216 enrolled

Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

Completed·UUniversity of Versailles·Phase 3·NCT00320099·508 enrolled

Initiation of Hydrocortisone for the Treatment of Septic Shock

Completed·NNorthern Jiangsu People's Hospital·N/A·NCT02580240·118 enrolled

Acute Lymphoblastic Leukemia9 trials

LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Completed·PPETHEMA Foundation·Phase 4·NCT00526305·100 enrolled

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Completed·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT01614197·16 enrolled

A Study in Adults With Untreated Acute Lymphoblastic Leukemia

Completed·—·Phase 2·NCT00136435·100 enrolled

Show 6 more trials

Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

Not yet recruiting· Novartis logo

Novartis·Phase 1/2·NCT07387926·50 enrolled

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Active, not recruiting·—·Phase 3·NCT03020030·560 enrolled

Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)

Unknown status·JJapan Adult Leukemia Study Group·Phase 2·NCT00131053·120 enrolled

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Recruiting·NNational Hospital Organization Nagoya Medical Center·Phase 2·NCT03286634·60 enrolled

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Completed·CChildren's Oncology Group·Phase 1·NCT03792256·12 enrolled

EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT01186328·6 enrolled

Prostate Cancer8 trials

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy

Completed·UUniversity of California, Davis·Phase 2·NCT00895310·30 enrolled

Trilostane for Androgen-Independent Prostate Cancer

Completed· Sanofi logo

Sanofi·Phase 2·NCT00181597·24 enrolled

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06136598·14 enrolled

Show 5 more trials

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06104449·6 enrolled

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Terminated·—·Phase 1/2·NCT00953576·11 enrolled

Ketoconazole and Dexamethasone in Prostate Cancer

Completed·UUniversity of California, San Francisco·Phase 2·NCT01036594·32 enrolled

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136650·1,314 enrolled

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT00859781·55 enrolled

Adrenal insufficiency8 trials

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

Recruiting·MMarianne Christina Klose·Phase 4·NCT05435781·250 enrolled

Optimising Steroid Replacement in Patients With Adrenal Insufficiency

Unknown status·TThe Adelaide and Meath Hospital, incorporating The National Children's Hospital·Phase 4·NCT03282487·60 enrolled

Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)

Unknown status·IImperial College London·Phase 3·NCT03936517·44 enrolled

Show 5 more trials

Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)

Completed·UUniversity Medical Center Groningen·Phase 4·NCT01546922·63 enrolled

Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

Terminated·MMax-Planck-Institute of Psychiatry·Phase 4·NCT01089075·32 enrolled

Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment

Recruiting·MMarianne Andersen·Phase 4·NCT05193396·100 enrolled

Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis

Withdrawn·—·Phase 4·NCT00368381

Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

Unknown status·UUniversity of Turin, Italy·Phase 2·NCT00657306·50 enrolled

98 more indications

Sepsis7 trials

Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis

Completed·IIMSS Hospital General de Zona 11, Piedras Negras·Phase 3·NCT04197115·19 enrolled

Days Alive and Out of Hospital for Patients With Sepsis

Completed·TThe George Institute for Global Health, Australia··NCT04567433·6,213 enrolled

Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.

Completed·—·Phase 2·NCT03422159·140 enrolled

Show 4 more trials

Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study

Completed·UUniversity Hospital Southampton NHS Foundation Trust·Phase 2·NCT00732277·21 enrolled

Vitamin C, Thiamine, and Steroids in Sepsis

Completed·EEmory University·Phase 3·NCT03509350·501 enrolled

Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06381661·2,000 enrolled

Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis

Terminated·UUniversitaire Ziekenhuizen KU Leuven·Phase 3·NCT02602210·100 enrolled

Congenital Adrenal Hyperplasia6 trials

Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Completed·—·Phase 2·NCT00621985·5 enrolled

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00001521·66 enrolled

Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia

Completed·UUniversity of Minnesota·Phase 1·NCT03718234·11 enrolled

Show 3 more trials

Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT01859312·8 enrolled

Androgen Reduction in Congenital Adrenal Hyperplasia

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT03548246

Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia

Unknown status·HHaukeland University Hospital·Phase 2·NCT01771328·20 enrolled

Pneumonia4 trials

HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study

Recruiting·IInstituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo·N/A·NCT05354778·180 enrolled

Community-Acquired Pneumonia : Evaluation of Corticosteroids

Completed·UUniversity Hospital, Tours·Phase 3·NCT02517489·952 enrolled

Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia

Withdrawn·UUniversity Hospital, Tours·Phase 3·NCT04359511

Show 1 more trial

Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

Recruiting·CCopenhagen Respiratory Research·Phase 4·NCT06892197·1,600 enrolled

Glucocorticoid4 trials

Glucocorticoid Administration After Traumatic Birth

Completed·UUniversity of Michigan·Phase 1·NCT04852458·133 enrolled

Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04536662·120 enrolled

Glucocorticoid Treatment for Social Phobia

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT01574014·66 enrolled

Show 1 more trial

Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions

Unknown status·WWest China Hospital·Phase 4·NCT02190994·100 enrolled

Post-Traumatic Stress Disorder3 trials

Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder

Completed·—·N/A·NCT01108146·30 enrolled

Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)

Withdrawn·UUniversity of California, San Diego·Phase 4·NCT00706173

Hydrocortisone for Prevention of Post-Traumatic Stress Disorder

Withdrawn·AAlbert Einstein Healthcare Network·N/A·NCT02402114

Hematologic Malignancies3 trials

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT05476770·54 enrolled

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT02419755·12 enrolled

Post-Traumatic Stress Disorder, PTSD3 trials

Cortisol Augmentation of a Psychological Treatment in Warfighters With Post Traumatic Stress Disorder (PTSD)

Unknown status·—·N/A·NCT01090518·50 enrolled

Efficacy of Single Dose IV Hydrocortisone in Post Traumatic Stress Disorder (PTSD) Prevention

Unknown status·SSheba Medical Center·N/A·NCT00855270·120 enrolled

Prevention of Posttraumatic Stress Disorder (PTSD) With Early Hydrocortisone Treatment: Pilot

Unknown status·KKent State University·N/A·NCT00597857·65 enrolled

Hypotension3 trials

Steroids on Intra-dialytic Hypotension

Completed·UUniversity of Jordan·N/A·NCT03465007·82 enrolled

Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

Enrolling by invitation·NNada kamel Elgamal·N/A·NCT06930456·120 enrolled

Hydrocortisone for Term Hypotension

Completed·NNICHD Neonatal Research Network·Phase 3·NCT01954056·12 enrolled

Atopic Dermatitis3 trials

Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

Terminated·RRutgers, The State University of New Jersey·N/A·NCT02289989·1 enrolled

Tacrolimus Versus Hydrocortisone in Atopic Dermatitis

Completed·—·Phase 4·NCT05324618·200 enrolled

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT05436535·433 enrolled

Pilot Study3 trials

Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH

Completed·NNeurocrine UK Limited·Phase 2·NCT01735617·16 enrolled

Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Terminated·UUniversity Medical Center Groningen·Phase 2·NCT02230930·13 enrolled

Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study

Completed·—·Phase 4·NCT02044159·57 enrolled

Acute Respiratory Distress Syndrome3 trials

Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Completed·MMahidol University·N/A·NCT01284452·197 enrolled

A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome

Recruiting·FFayoum University·Phase 2/3·NCT06496997·300 enrolled

Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)

Unknown status·SSoutheast University, China·Phase 4·NCT00773058·100 enrolled

Stress2 trials

Cannabinoids and Biological Reactivity to Stress

Recruiting·FFlorida State University·Phase 1·NCT06430580·36 enrolled

Neural Correlates of Stress Hormones

Completed·—·N/A·NCT02523664·78 enrolled

Total Knee Arthroplasty2 trials

Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty

Completed·HHospital for Special Surgery, New York·Phase 4·NCT01815918·60 enrolled

Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)

Active, not recruiting·HHospital for Special Surgery, New York·Phase 4·NCT04082533·132 enrolled

Transplantation2 trials

Allogeneic Transplantation From Related Haploidentical Donors

Completed·SStanford University·Phase 2·NCT00185692·16 enrolled

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

Completed·SStanford University·Phase 2·NCT00899847·9 enrolled

Complication2 trials

Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection

Completed·TTampere University Hospital·Phase 2·NCT01460615

HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications

Active, not recruiting·HHelsinki University Central Hospital·Phase 4·NCT02775227·126 enrolled

Steroid2 trials

Peri-Operative Steroid Management in Patients

Completed·WWashington University School of Medicine·N/A·NCT02084134·43 enrolled

Steroid-reducing Effects of Crisaborole

Completed·JJohns Hopkins University·Phase 4·NCT03832010·24 enrolled

Cardiac Arrest2 trials

Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest

Completed·—·Phase 1/2·NCT00676585·50 enrolled

Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest

Completed·NNational Taiwan University Hospital·N/A·NCT00172354·100 enrolled

After Cardiac Surgery2 trials

Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

Completed·LLudwig-Maximilians - University of Munich·Phase 4·NCT00490828·120 enrolled

Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT00415701·130 enrolled

COVID-192 trials

Hydrocortisone for COVID-19 and Severe Hypoxia

Completed·SScandinavian Critical Care Trials Group·Phase 3·NCT04348305·30 enrolled

Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

No longer available·MMesoblast International Sàrl··NCT04456439

Adult Acute Lymphoblastic Leukemia2 trials

Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma

Terminated·UUniversity of California, San Diego·Phase 2·NCT02043587·31 enrolled

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00853008·100 enrolled

Leukemia2 trials

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00133991·23 enrolled

Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT03913559·5 enrolled

Sleep Restriction2 trials

Hormonal Mechanisms of Sleep Restriction - Axis Study

Active, not recruiting·PPeter y. Liu·Phase 1·NCT03142893·80 enrolled

Hormonal Mechanisms of Sleep Restriction

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1·NCT02256865·40 enrolled

Bronchopulmonary Dysplasia2 trials

Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004669·40 enrolled

PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00623740·523 enrolled

Psoriasis Vulgaris2 trials

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT00691002·1,245 enrolled

A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT01007591·40 enrolled

Hypothermia2 trials

Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns

Completed·SSemmelweis University·Phase 2/3·NCT02700828·32 enrolled

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

Recruiting·SSemmelweis University·Phase 4·NCT05836610·50 enrolled

Glucocorticoids2 trials

Biomarker(s) for Glucocorticoids

Completed·VVastra Gotaland Region·N/A·NCT02152553·11 enrolled

Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

Completed·YYale University·Phase 1·NCT02722200·28 enrolled

Headache1 trial

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Completed·—·Phase 4·NCT03910088·30 enrolled

Memory1 trial

Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Completed·YYale University·Phase 1·NCT04896489·27 enrolled

Intussusception1 trial

Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception

Recruiting·—·N/A·NCT02691858·80 enrolled

Phimosis1 trial

Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Withdrawn·CChelsea and Westminster NHS Foundation Trust·Phase 4·NCT00933023

Blood Pressure Management1 trial

Early Blood Pressure Management in Extremely Premature Infants

Completed·NNICHD Neonatal Research Network·Phase 1·NCT00874393·10 enrolled

Sjögren Syndrome1 trial

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Completed·HHospital Hietzing·N/A·NCT04597762·12 enrolled

Hypopituitarism1 trial

The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism

Terminated·IInsel Gruppe AG, University Hospital Bern·N/A·NCT02360046·30 enrolled

Poisoning1 trial

The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning

Completed·TTanta University·N/A·NCT04465539·60 enrolled

Overweight1 trial

Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Withdrawn·UUniversity of Virginia·Phase 1·NCT01422707

Chemotherapy1 trial

Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

Recruiting·CC17 Council·Phase 1·NCT06942039·15 enrolled

Interaction1 trial

CRF - Nociceptin Receptor Interactions

Completed·UUniversity of Pittsburgh·Phase 1·NCT03302416·19 enrolled

Relapsed/Refractory1 trial

Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

Completed·—·Phase 1·NCT03349281·6 enrolled

Renal Failure1 trial

Effect of Cortisol on Physical Exertion in Patients With Primary Adrenal Failure

Unknown status·HHaukeland University Hospital·Phase 2·NCT01847690·20 enrolled

Mitral Valve Surgery1 trial

Post-operative Corticosteroid Treatment After Mitral Valve Surgery

Withdrawn·KKuopio University Hospital·Phase 2/3·NCT03682393

Treatment1 trial

Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)

Recruiting·AAgnes·Phase 3·NCT05668455·30 enrolled

Adenoma1 trial

Hydrocortisone Use During Peri-operation for Pituitary Adenomas

Unknown status·PPeking Union Medical College Hospital·N/A·NCT04621565·436 enrolled

mCRPC1 trial

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136624·1,310 enrolled

Attention1 trial

The Role of Stress Neuromodulators in Decision Making Under Risk and Selective Attention to Threat

Completed·—·N/A·NCT04359147·167 enrolled

Low Birth Weight1 trial

Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

Completed·UUniversity of British Columbia·Phase 3·NCT00358748·40 enrolled

Prevention1 trial

Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Completed·SStanford University·Phase 2·NCT00186628·36 enrolled

Mitochondria1 trial

Mitochondrial Function in Septic Patients

Completed·—·N/A·NCT03748537·20 enrolled

Efficacy1 trial

A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH

Completed·NNeurocrine UK Limited·Phase 3·NCT03062280·91 enrolled

Cognition1 trial

Effects of Glucocorticoids on Cognition in HIV-infected Women

Completed·JJohns Hopkins University·Phase 1·NCT03237689·136 enrolled

Colitis1 trial

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

Completed·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Phase 4·NCT02425852·65 enrolled

Congenital Heart Disease1 trial

Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

Completed·—·Phase 2·NCT00590018·18 enrolled

Asthma1 trial

A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics

Terminated·RRoyal Brompton & Harefield NHS Foundation Trust··NCT02270827·5 enrolled

Atopic1 trial

Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease

Completed·UUniversity Hospital Muenster·Phase 2·NCT00507832·30 enrolled

Hyperglycemia1 trial

Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock

Completed·SSrinakharinwirot University·Phase 4·NCT02266264·80 enrolled

Intrusive Memories1 trial

Cortisol and the Formation of Intrusive Memories

Completed·—·N/A·NCT02552654·60 enrolled

Inflammatory Response1 trial

Cortisol Control of Human Inflammatory Responses to Endotoxin

Completed·—·N/A·NCT00396344·36 enrolled

Corticosteroids1 trial

Exploring the Effects of Corticosteroids on the Human Hippocampus

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT03896659·66 enrolled

Atrial Fibrillation1 trial

Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

Terminated·KKuopio University Hospital·N/A·NCT00442494·1 enrolled

Postmenopausal Women1 trial

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Active, not recruiting·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1·NCT04037605·5 enrolled

Breast Cancer1 trial

StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients

Withdrawn·OOHSU Knight Cancer Institute·N/A·NCT05073172

Meibomian Gland Dysfunction1 trial

Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction

Recruiting·LLaboratorios Thea, Spain·Phase 4·NCT05159284·54 enrolled

Intraocular Pressure1 trial

Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure

Completed·UUniversity of Molise·N/A·NCT04536129·90 enrolled

Histiocytosis1 trial

Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

Completed·—·Phase 2·NCT01104025·31 enrolled

Veteran1 trial

Veteran Stress and Learning Study

Completed·VVA Office of Research and Development·Phase 4·NCT00674570·111 enrolled

Cortisol1 trial

Association Between Low Cortisol Levels and Whiplash Syndrome

Unknown status·SSoroka University Medical Center·Phase 2·NCT02090309·90 enrolled

Function1 trial

Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT00591006·17 enrolled

Intensive Care1 trial

Hydrocortisone Use After Etomidate in Intensive Care

Completed·UUniversity Hospital, Grenoble·Phase 3·NCT00862381·106 enrolled

Erythema1 trial

Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Completed·—·Phase 1/2·NCT02756546·100 enrolled

Necrotizing Enterocolitis1 trial

Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants

Terminated·EEndeavor Health·N/A·NCT01156480·2 enrolled

Phase 21 trial

Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

Terminated·SStanford University·Phase 2·NCT00482053·3 enrolled

Abdominal Surgeries1 trial

Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries

Recruiting·—·Phase 4·NCT07154849·70 enrolled

Total Knee Replacement1 trial

Steroids in Bilateral Total Knee Replacement

Completed·HHospital for Special Surgery, New York·Phase 4·NCT01399268·30 enrolled

Blood Cancer1 trial

Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

Available·AAVM Biotechnology Inc··NCT05974410

Adjuvant Therapy1 trial

Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu

Terminated·UUniversity of Versailles·Phase 3·NCT01014364·40 enrolled

Prolonged1 trial

Cortisol Augmentation of Prolonged Exposure Therapy

Completed·VVISN 3 Mental Illness Research, Education and Clinical Center·N/A·NCT00751855·11 enrolled

Insulin Secretion1 trial

Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans

Completed·MMedical University of Vienna·Phase 4·NCT00709839·10 enrolled

Fatigue1 trial

Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism

Unknown status·UUlla Feldt-Rasmussen·Phase 4·NCT02282150·30 enrolled

Acute Myocardial Infarction1 trial

The Effect of Glucocorticoid Therapy on Left Ventricular Remodelling in Acute Myocardial Infarction (RECONSIDER)

Unknown status·IIuliu Hatieganu University of Medicine and Pharmacy·Phase 2/3·NCT03371784·77 enrolled

Lymphoblastic Lymphoma1 trial

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01451515·23 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Recruiting·CCopenhagen Respiratory Research·Phase 4·NCT06892210·2,000 enrolled

Memory Impairment1 trial

Vilazodone for Corticosteroid-Induced Memory Impairment

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT01828515·24 enrolled

Microcirculation1 trial

Effects of Intravenous Metabolic Recovery Agent in Elderly Septic Patients on Prognosis and Microcirculation.

Recruiting·SSoutheast University, China·N/A·NCT06723626·40 enrolled

Current Smoker1 trial

Investigation of Nicotine Seeking Behavior in Current Smokers

Completed·WWayne State University·Phase 1·NCT03670212·21 enrolled

AIN1 trial

Metabolic Effects of Cocaine

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00451230·15 enrolled

LAM1 trial

The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation

Completed·OOregon Health and Science University·N/A·NCT00688987·24 enrolled

Lipomatosis1 trial

Hydrocortisone Treatment for Symmetric Lipomatosis Associated With Neuropathy (SLN): an N-of-1 Study Hydrocortisone Treatment for Symmetric Lipomatosis Associated With Neuropathy (SLN): an N-of-1 Study

Unknown status·EErasmus Medical Center·Phase 3·NCT04821583·1 enrolled

Cardiopulmonary Bypass1 trial

Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01595386·40 enrolled

Pancreatitis1 trial

Corticosteroids to Treat Pancreatitis

Recruiting·—·Phase 2·NCT05160506·86 enrolled

Polytrauma1 trial

Treatment of Polytraumatisms With Corticoids

Completed·NNantes University Hospital·Phase 2/3·NCT00563303·150 enrolled

Renal Transplantation1 trial

RituxiMab INDuction in Renal Transplantation

Unknown status·GGuy's and St Thomas' NHS Foundation Trust·Phase 4·NCT01095172·100 enrolled

Lymphoma1 trial

Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Unknown status·PPETHEMA Foundation·Phase 2·NCT05049473·100 enrolled

Sjögren's Syndrome1 trial

Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Unknown status·DDerk Jan Jager·N/A·NCT02112019·50 enrolled

Intestinal Perforation1 trial

Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants

Active, not recruiting·IImperial College London··NCT06515405·16,000 enrolled

Inflammation1 trial

Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery

Completed·HHospital for Special Surgery, New York·N/A·NCT01782859·40 enrolled

Not yet recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 2·NCT07686107·24 enrolled

Unspecified2 trials

Role Of Sensitivity to neuroEndocrine Systems in Social Decisions

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT06018727

UVB Model Validation Study

Completed·XX-pert Med GmbH·Phase 1·NCT01055249·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CORTEF

NDA NDA009864

Jan 1, 1982

CORTEF ACETATE

NDA NDA009378

Jan 1, 1982

CORTRIL

NDA NDA009164

Jan 1, 1982

HYDROCORTISONE ACETATE

NDA NDA009637

Jan 1, 1982

HYDROCORTONE

NDA NDA008228

Jan 1, 1982

HYDROCORTONE

NDA NDA012052

Jan 1, 1982

SOLU-CORTEF

NDA NDA009866

Jan 1, 1982

CORT-DOME

NDA NDA009895

Jan 1, 1982

HYDROCORTONE

NDA NDA009018

Jan 1, 1982

CORTEF ACETATE

NDA NDA008917

Jan 1, 1982

CORTRIL

NDA NDA009176

Jan 1, 1982

CORTEF

NDA NDA008697

Jan 1, 1982

CORTRIL

NDA NDA009127

Jan 1, 1982

HYDROCORTISONE

NDA NDA009659

Jan 1, 1982

HYDROCORTONE

NDA NDA008506

Jan 1, 1982

CORTRIL

NDA NDA009796

Jan 1, 1982

CORT-DOME

NDA NDA009585

Jan 1, 1982

WESTCORT

NDA NDA017950

Jan 1, 1982

CORTENEMA

NDA NDA016199

Feb 10, 1982

CORTIFOAM

NDA NDA017351

Aug 8, 1983

WESTCORT

NDA NDA018726

Sep 29, 2020

ALKINDI SPRINKLE

NDA NDA213876

May 28, 2025

KHINDIVI

NDA NDA218980

Sources

References

[1]
ClinicalTrials.gov — 203 trial records for Hydrocortisone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cortef drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Hydrocortisone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Hydrocortisone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218980). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cortef. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patent Landscape[6]

Patent Cliff

Nov 19, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9717740Nov 19, 2032

9675559Jan 10, 2033

9649280May 12, 2034

12133914Feb 23, 2043

11904046Feb 23, 2043