Data updated: May 26, 2026
CORTEF (hydrocortisone)
Corticosteroid Hormone Receptor Agonists
Trial Activity: Declining
Immunology
Approved 1952-12-15
CORTEF is indicated for the treatment of Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Thyroiditis; Hypercalcemia; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Bursitis; Tenosynovitis; Gouty Arthritis.
Source: FDA Label • PHARMACIA AND UPJOHN
Development Insights
Neurocrine UK Limited conducting 3 trials (75%)
4 indications explored (Focused)
→ adrenal insufficiency (2 trials)
→ congenital adrenal hyperplasia (1 trials)
→ addison disease (1 trials)
2
Indications
--
Phase 3 Trials
73
Years on Market
Details
- Status
- Prescription
- First Approved
- 1952-12-15
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, SUSPENSION, INJECTABLE
CORTEF Approval History
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Original
New Indication
New Form
Label Update
39 FDA actions from 1952 to 2024
Mar 2001 SUPPL
Mfg
Dec 1997 SUPPL
Mfg
Dec 1993 SUPPL
Mfg
Aug 1990 SUPPL
Mfg
Mar 1983 SUPPL
Mfg
Jun 1982 SUPPL
Mfg
Jun 1979 SUPPL
Label
Feb 1978 SUPPL
Label
May 1955 ORIGINAL
New Form
Dec 1952 ORIGINAL
Update
What CORTEF Treats
10 indicationsCORTEF is approved for 10 conditions since its original approval in 1952. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Thyroiditis
- Hypercalcemia
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Bursitis
Source: FDA Label
CORTEF Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CORTEF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CORTEF treats. First-in-class if their pivotal trials read out positive.
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Ianalumab VAY736 ✓ Won — Ph3 readout
Novartis Pharmaceuticals TNFRSF13C · monoclonal antibody (anti-BAFF-R, glycoengineered for ADCC) · 8 Phase 3 trials
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
Drugs Similar to CORTEF
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
PREDNISONE INTENSOL
PREDNISONE
Hikma
Shared indications:
Adrenocortical InsufficiencyCongenital Adrenal HyperplasiaHypercalcemia +6 more
KENALOG-10
TRIAMCINOLONE ACETONIDE
APOTHECON
Shared indications:
Gouty ArthritisBursitisTenosynovitis +1 more
📋
Clinical Trial Registry
98 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06982183 | WRAIR #2950 MO210072 | Ph 4 | recruiting | The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes |
| NCT06136650 | 5684-004 MK-5684-004, jRCT2031240030 | Ph 3 | recruiting | 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) |
| NCT03286634 | ASIA-DS-ALL-2016 | Ph 2 | active not recruiting | ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 |
| NCT06136624 OMAHA-003 | 5684-003 2023-504899-25-00, MK-5684-003 | Ph 3 | recruiting | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) |
| NCT05836610 UniCort | SU-Ped-AsphCort 002 | Ph 4 | recruiting | Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates |
| NCT06104449 | 5684-005 MK-5684-005, jRCT2031230431 | Ph 1 | completed | A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) |
| NCT00859781 results posted | 0810010067 J591+Ketoconazole | Ph 2 | active not recruiting | 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer |
| NCT04924166 | GCO 18-0090 W81XWH1910138 | Ph 2 | completed | PTSD Prevention Using Oral Hydrocortisone |
| NCT06136598 | 5684-001 MK-5684-001 | Ph 1 | completed | A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) |
| NCT06892197 | MineraloCAP | Ph 4 | recruiting | Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP) |
| NCT06892210 | MineraloCOP | Ph 4 | recruiting | Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) |
| NCT05435781 RESCUE | RESCUE 2021-002528-18, H-21041930 | Ph 4 | recruiting | Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency |
| NCT05292664 | 21-757 | Ph 1 | recruiting | Venetoclax Basket Trial for High Risk Hematologic Malignancies |
| NCT05436535 LEADS | DAIT ADRN-12 | Ph 4 | completed | Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis |
| NCT05160506 CRISP | 2021P-000803 | Ph 2 | recruiting | Corticosteroids to Treat Pancreatitis |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT06381661 PALETTE | APHP240385 | Ph 2 | not yet recruiting | Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial |
| NCT03020030 | 16-001 | Ph 3 | active not recruiting | Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents |
| NCT02517489 CAPE_COD | PHRN14-PFD/CAPE COD | Ph 3 | completed | Community-Acquired Pneumonia : Evaluation of Corticosteroids |
| NCT05193396 REPLACE | REPLACE 2024-513822-53-00, 2020-006121-65 | Ph 4 | recruiting | Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment |
| NCT02473263 SSS | 2014-A01030-47 | Ph 3 | completed | Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock |
| NCT04082533 | 2018-0660 | Ph 4 | active not recruiting | Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty) |
| NCT07154849 | FMASU MS581 /2024 | Ph 4 | recruiting | Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries |
| NCT05668455 CRYSTAL | 35RC21_8901_CRYSTAL | Ph 3 | recruiting | Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses) |
| NCT03792256 results posted | AINV18P1 NCI-2019-02774 | Ph 1 | completed | Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) |
| NCT00691002 results posted | LEO 80190-O21 | Ph 3 | completed | Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds |
| NCT01007591 results posted | LEO 80190-O25 | Ph 3 | completed | 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 |
| NCT01353313 results posted | NICHD-NRN-0045 U10HD034216, U10HD027904 | Ph 3 | completed | Hydrocortisone for BPD |
| NCT05063994 CONnECT results posted | DIUR-014 | Ph 3 | completed | Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia |
| NCT06496997 | Steroids Efficacy in ARDS | Ph 2, Ph 3 | recruiting | A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome |
| NCT05476770 | T2020-006 | Ph 1 | recruiting | Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies |
| NCT03062280 results posted | DIUR-006 | Ph 3 | completed | A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH |
| NCT02096510 | 2013/1738 | Ph 1, Ph 2 | completed | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia |
| NCT06018727 ROSES | 22-1839 | Ph 4 | withdrawn | Role Of Sensitivity to neuroEndocrine Systems in Social Decisions |
| NCT01186328 results posted | T2009-007 | Ph 1 | terminated | EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) |
| NCT01614197 results posted | T2014-001 | Ph 1 | completed | A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma |
| NCT05324618 | Tacrolimus vs Hydrocortisone | Ph 4 | completed | Tacrolimus Versus Hydrocortisone in Atopic Dermatitis |
| NCT02425852 ACTIVE | GETAID 2015-02 | Ph 4 | completed | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis |
| NCT02700828 CORTISoL | 1Ped-AsphCort 001 | Ph 2, Ph 3 | completed | Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns |
| NCT03548246 ARCH | 042015-068 | Ph 2 | withdrawn | Androgen Reduction in Congenital Adrenal Hyperplasia |
| NCT03349281 | 20170602 X15015 | Ph 1 | completed | Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL |
| NCT01451515 results posted | NHL16 NCI-2012-00496 | Ph 2 | completed | NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma |
| NCT02722200 | 1510016716 2R01DK020495-42 | Ph 1 | completed | Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger |
| NCT02043587 | 130934 | Ph 2 | terminated | Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma |
| NCT01815918 results posted | 2012-054 | Ph 4 | completed | Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty |
| NCT03682393 MitralPOCS | KUH5101126 | Ph 2, Ph 3 | withdrawn | Post-operative Corticosteroid Treatment After Mitral Valve Surgery |
| NCT03422159 ORANGES results posted | 17-004 | Ph 2 | completed | Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis. |
| NCT04348305 COVID STEROID | RH-ITA-008 2020-001395-15 | Ph 3 | completed | Hydrocortisone for COVID-19 and Severe Hypoxia |
| NCT01954056 results posted | NICHD-NRN-0052 U10HD021364, U10HD040689 | Ph 3 | completed | Hydrocortisone for Term Hypotension |
| NCT03710187 results posted | UHS-CC-002 | Ph 2 | completed | HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients |
Showing 50 of 98 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CORTEF FDA Label Details
Indications & Usage
FDA Label (PDF)CORTEF is indicated for the treatment of Adrenocortical Insufficiency; Congenital Adrenal Hyperplasia; Thyroiditis; Hypercalcemia; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Bursitis; Tenosynovitis; Gouty Arthritis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment