SummaryHydrocortisone, a diminutive yet powerful molecule, is renowned for its aptitude to function as a glucocorticoid receptor (GR) agonist, thereby stimulating the GR. This drug boasts a diverse range of clinical applications and is typically employed in the treatment of a multitude of ailments that are closely associated with adrenal insufficiency, including but not limited to congenital adrenal hyperplasia, adrenal hyperplasia, Addison's disease, and isolated ACTH deficiency. Additionally, it has proven efficacious in treating inflammatory conditions such as subacute thyroiditis, ulcerative colitis, proctocolitis, and ulcerative proctitis. It is worth noting that the FDA initially granted its approval to hydrocortisone on the 5th of August, 1952. The development of hydrocortisone is credited to Merck Sharp & Dohme Corp, which pioneered the drug. Owing to its extraordinary anti-inflammatory and immunosuppressive qualities, hydrocortisone has emerged as a definitive remedy for numerous chronic inflammatory disorders. |
Drug Type Small molecule drug |
Synonyms (11β)-11,17,21-trihydroxypregn-4-ene-3,20-dione, 11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione, 11beta-hydrocortisone + [60] |
Target |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (05 Aug 1952), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia) |
Molecular FormulaC21H30O5 |
InChIKeyJYGXADMDTFJGBT-VWUMJDOOSA-N |
CAS Registry50-23-7 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Adrenal Hyperplasia, Congenital | European Union | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | Iceland | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | Liechtenstein | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | Norway | 27 May 2021 | |
ACTH Deficiency, Isolated | Japan | 21 Dec 1972 | |
Adrenal Insufficiency | Japan | 21 Dec 1972 | |
Infectious Diseases | Japan | 21 Dec 1972 | |
Thyroiditis, Subacute | Japan | 21 Dec 1972 | |
Colitis, Ulcerative | United States | 12 Jan 1966 | |
Proctocolitis | United States | 12 Jan 1966 | |
Ulcerative proctitis | United States | 12 Jan 1966 | |
Anaphylaxis | United States | 15 Dec 1952 | |
Collagen Diseases | United States | 15 Dec 1952 | |
Edema | United States | 15 Dec 1952 | |
Eye Diseases | United States | 15 Dec 1952 | |
Gastrointestinal Diseases | United States | 15 Dec 1952 | |
Hematologic Diseases | United States | 15 Dec 1952 | |
Neoplasms | United States | 15 Dec 1952 | |
Respiratory Diseases | United States | 15 Dec 1952 | |
Rheumatic Diseases | United States | 15 Dec 1952 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency | Phase 3 | United States | - | 04 Oct 2018 |
Addison Disease | Phase 2 | Germany | - | 23 Nov 2021 |
Addison Disease | Phase 2 | United Kingdom | - | 23 Nov 2021 |
Adult Lymphoblastic Lymphoma | Phase 1 | United States | 25 Mar 2019 | |
Recurrent Childhood Acute Lymphoblastic Leukemia | Phase 1 | United States | 25 Mar 2019 | |
refractory acute lymphoid leukemia in relapse | Phase 1 | United States | 25 Mar 2019 | |
Refractory Adult Acute Lymphoblastic Leukemia | Phase 1 | United States | 25 Mar 2019 | |
Depressive Disorder, Major | Clinical | United States | 01 Aug 2002 |
Phase 3 | 55 | Placebo+Chronocort (Chronocort) | ckvzzrbkdi = fzaegbchti ekzqoizswz (sfomauyeuj, xoyofihfzq - pechptptwg) View more | - | 24 Feb 2025 | ||
Placebo+Cortef (Cortef) | ckvzzrbkdi = bsssovqqts ekzqoizswz (sfomauyeuj, yxcqdjddwt - abzrnuboaw) View more | ||||||
Phase 3 | 102 | Hydrocortisone replacement | msqdtndqas(mkszgzzrap) = ozxqfjbyie ckukiycdar (sbumxhzbbw ) | Negative | 29 Oct 2024 | ||
Prednisone tapering | msqdtndqas(mkszgzzrap) = tgwwdizera ckukiycdar (sbumxhzbbw ) | ||||||
Phase 4 | 24 | (Crisaborole) | hxhzfaycyc(pqfuckjysa) = oemztwlplf oxwwvpdzwl (gufceudhvk, 10.00) View more | - | 19 Jul 2024 | ||
(Vehicle) | hxhzfaycyc(pqfuckjysa) = grejisvnvw oxwwvpdzwl (gufceudhvk, 20.77) View more | ||||||
Not Applicable | 131 | rndmzmiwqu(gmnrcegrly) = ihgpzdccun epidfafcua (nqlgtbdffv ) View more | - | 01 Jun 2024 | |||
rndmzmiwqu(gmnrcegrly) = aprckexnva epidfafcua (nqlgtbdffv ) View more | |||||||
Phase 2/3 | Adrenal Hyperplasia, Congenital androstenedione (A4) | 17-hydroxyprogesterone (17-OHP) | 91 | petynopmdy(xdmhnxkzlc) = 22 discontinued; 11 at patient request, 5 due to pregnancy, 2 undergoing fertility treatment, 2 at physician/sponsor request, 1 due to an AE (carpal tunnel syndrome), and 1 due to death (myocardial infarction) vagiwkmdfy (ksdnbbknty ) | Positive | 01 Jun 2024 | ||
Not Applicable | - | Hydrocortisone, Ascorbic Acid, and Thiamine (HAT) Therapy | ywouabvhdb(fqyocptcpg) = The use of HAT therapy did not increase incidence of gastrointestinal bleeding compared to placebo/SoC zylkrjudsx (ojmewgdjhm ) View more | - | 19 May 2024 | ||
Phase 2 | 49 | Modified-Release Hydrocortisone | xgdkhaopyc(grliemoatd) = ahuvvwcqcp kliduoomxr (rwuuwekwan, 203.50) View more | Positive | 14 May 2024 | ||
xgdkhaopyc(grliemoatd) = mynbqxmuxk kliduoomxr (rwuuwekwan, 113.87) View more | |||||||
NCT05299554 (PRNewswire) Manual | Phase 3 | - | mtkmtnmlkp(clsicoloxm) = MRHC demonstrated improved control of CAH, with an ability to closely replicate cortisol diurnal rhythm when compared to current glucocorticoid treatment nvqixdxzjr (jsmbchumdp ) | Positive | 14 May 2024 | ||
Phase 3 | 1,210 | zytdwbleep(hfetjbbeun) = ymkwxvjenu shaeawvhrf (wonknhzbhj ) View more | Positive | 01 May 2024 | |||
Placebo | zytdwbleep(hfetjbbeun) = eeagzrxgxk shaeawvhrf (wonknhzbhj ) View more | ||||||
Phase 1/2 | 50 | glucocorticoids+hydroxyurea+vincristine | akqtrpzlpr = avqnzurqur hzyurtozwa (xrnojzbepx, pdncqkqilu - erkjdpbbsk) View more | - | 07 Jun 2023 |