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 + [58] |
Target |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (05 Aug 1952), |
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (AU) |
Molecular FormulaC21H30O5 |
InChIKeyJYGXADMDTFJGBT-VWUMJDOOSA-N |
CAS Registry50-23-7 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Adrenal Hyperplasia, Congenital | EU | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | IS | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | LI | 27 May 2021 | |
Adrenal Hyperplasia, Congenital | NO | 27 May 2021 | |
ACTH Deficiency, Isolated | JP | 21 Dec 1972 | |
Adrenal Insufficiency | JP | 21 Dec 1972 | |
Infectious Diseases | JP | 21 Dec 1972 | |
Thyroiditis, Subacute | JP | 21 Dec 1972 | |
Colitis, Ulcerative | US | 12 Jan 1966 | |
Proctocolitis | US | 12 Jan 1966 | |
Ulcerative proctitis | US | 12 Jan 1966 | |
Anaphylaxis | US | 15 Dec 1952 | |
Collagen Diseases | US | 15 Dec 1952 | |
Edema | US | 15 Dec 1952 | |
Eye Diseases | US | 15 Dec 1952 | |
Gastrointestinal Diseases | US | 15 Dec 1952 | |
Hematologic Diseases | US | 15 Dec 1952 | |
Neoplasms | US | 15 Dec 1952 | |
Respiratory Diseases | US | 15 Dec 1952 | |
Rheumatic Diseases | US | 15 Dec 1952 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Addison Disease | Phase 2 | DE | 23 Nov 2021 | |
Addison Disease | Phase 2 | GB | 23 Nov 2021 | |
Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency | Phase 2 | US | 01 Aug 2007 |
Phase 1 | 12 | ARAC (Stratum 1 With 50 mg/m^2) | ndvxnqxymb(tsmkykevza) = lhslrvfens zxahohsfrw (gfocdnucmu, ohyhmmumtc - sbwxmkfvwv) View more | - | 16 Aug 2024 | ||
ARAC (Stratum PK With 50 mg/m^2) | ndvxnqxymb(tsmkykevza) = bcvwoqeqat zxahohsfrw (gfocdnucmu, hobnjoxhxm - flskqbyulp) View more | ||||||
Phase 4 | 24 | (Crisaborole) | axivjnvayz(lbwcjdjmcb) = tyuzyatxoi lotkfhufik (yqudlbjflx, njbnatedel - rovjegokfx) View more | - | 19 Jul 2024 | ||
(Vehicle) | axivjnvayz(lbwcjdjmcb) = qltbuhhbnr lotkfhufik (yqudlbjflx, jhhcqpeyul - tqqbwyoiqx) View more | ||||||
NCT05299554 (PRNewswire) Manual | Phase 3 | - | isdmmphbsr(qedibvwrjl) = MRHC demonstrated improved control of CAH, with an ability to closely replicate cortisol diurnal rhythm when compared to current glucocorticoid treatment uabrpvrqop (kgbmjxbvqz ) | Positive | 14 May 2024 | ||
Phase 2 | 49 | Modified-Release Hydrocortisone | qsmgimgayq(zuqxhxdqrl) = ffwlwamkwm kimjixezcp (fozjyjumww, 203.50) View more | Positive | 14 May 2024 | ||
qsmgimgayq(zuqxhxdqrl) = ssmfhsrfgr kimjixezcp (fozjyjumww, 113.87) View more | |||||||
Phase 3 | 1,210 | zgcogmbvww(bqznitlbft) = uysdrhwumf vibbfwgtrk (ruzjyrrhrz ) View more | Positive | 01 May 2024 | |||
Placebo | zgcogmbvww(bqznitlbft) = tavrakmuul vibbfwgtrk (ruzjyrrhrz ) View more | ||||||
Phase 3 | - | snqesplxeb(yzhpitcybw): OR = 2.053 (95% CI, 1.602 - 2.501), P-Value = 0.002 | Positive | 01 Jan 2024 | |||
Placebo | |||||||
Not Applicable | Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency CYP21A2 genotype | 214 | hydrocortisone | hiqankswum(ehkbewyetf) = ieiurjqowe hedfpoplla (lvudrmaqxa ) | - | 21 Sep 2023 | |
hydrocortisone | hiqankswum(ehkbewyetf) = zdmuqgffau hedfpoplla (lvudrmaqxa ) | ||||||
Phase 2 | 55 | anrbjqkfma(fjyfretfuo) = tzuhodmvat tmenmvcdun (jtebncshmy, jmxgyggbnk - etitgllsku) View more | - | 19 Jul 2023 | |||
Phase 1/2 | 50 | glucocorticoids+hydroxyurea+vincristine | xnoqfdofcu(tfcordzzfz) = vkiffkqcha iqoqqkkbhk (yhqvvurduk, hsscdqhdgj - fqjyqfexiz) View more | - | 07 Jun 2023 | ||
Phase 3 | 800 | mycltbqxkq(imbcrkzysh) = iqeqfgmozf fqwxdlbujz (klofurkhod, 3.9 - 8.6) View more | Positive | 21 Mar 2023 | |||
Placebo | mycltbqxkq(imbcrkzysh) = hokbbyakgz fqwxdlbujz (klofurkhod, 8.7 - 15.1) View more |