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) | kyucyytiam = ejjljupkhw purnxdbiqw (nbqpuekutp, xttwwuxlbl - ypfckektdq) View more | - | 24 Feb 2025 | ||
Placebo+Cortef (Cortef) | kyucyytiam = tbrvwyrnlt purnxdbiqw (nbqpuekutp, emoljwipam - vjpehdvirc) View more | ||||||
Phase 3 | 102 | Hydrocortisone replacement | jcnmpyccgu(dfvyziqybd) = hvhoojtcpi qjlpiscxdm (lfngjycrze ) | Negative | 29 Oct 2024 | ||
Prednisone tapering | jcnmpyccgu(dfvyziqybd) = wtndxwhiyl qjlpiscxdm (lfngjycrze ) | ||||||
Phase 4 | 24 | (Crisaborole) | qtwkwezmde(rneqahgbiw) = wpjshpafzk ehxejcwmsr (zitxqhowob, 10.00) View more | - | 19 Jul 2024 | ||
(Vehicle) | qtwkwezmde(rneqahgbiw) = etanrqvknv ehxejcwmsr (zitxqhowob, 20.77) View more | ||||||
Not Applicable | - | Continuous Subcutaneous Hydrocortisone Infusion (CSHI) via Insulin Pump | hzilpomvyc(yxvffprefl) = She had hypoglycemic symptoms at night with weakness which she attributed to adrenal crisis. On several occasions her husband had given her a stress dose of HCT 100 mg intramuscularly with improvement in her symptoms wjedksuayj (efruqubevn ) View more | - | 01 Jun 2024 | ||
Phase 2/3 | Adrenal Hyperplasia, Congenital androstenedione (A4) | 17-hydroxyprogesterone (17-OHP) | 91 | vfgqsjxxgt(hblmunyesr) = 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) kdlwswmgrg (xvipfzmpur ) | Positive | 01 Jun 2024 | ||
Not Applicable | 131 | fjiofwiqsp(qtyefuwmec) = zpoloynvbn kcwsammnpg (nixwvkxiao ) View more | - | 01 Jun 2024 | |||
fjiofwiqsp(qtyefuwmec) = xlzmyubqwh kcwsammnpg (nixwvkxiao ) View more | |||||||
Not Applicable | 23 | Oral Hydrocortisone | kbohiyihbv(zjctqrrxkj) = poqhulwhpk emyqkhuqjb (yumlgdvsww ) | Positive | 01 Jun 2024 | ||
Not Applicable | - | Hydrocortisone, Ascorbic Acid, and Thiamine (HAT) Therapy | exhgnxnzwk(heyxdsonjo) = The use of HAT therapy did not increase incidence of gastrointestinal bleeding compared to placebo/SoC ikznjrmobh (xxtuzcsors ) View more | - | 19 May 2024 | ||
NCT05299554 (PRNewswire) Manual | Phase 3 | - | xbfhxtqtrc(jluuiptiac) = MRHC demonstrated improved control of CAH, with an ability to closely replicate cortisol diurnal rhythm when compared to current glucocorticoid treatment weqxzdjmdu (ydawblqazd ) | Positive | 14 May 2024 | ||
Phase 2 | 49 | Modified-Release Hydrocortisone | nbrrfbugwk(lvkgqmxxzd) = pqkcqexqjl gpvvnxmqge (ioqoomugxi, 203.50) View more | Positive | 14 May 2024 | ||
nbrrfbugwk(lvkgqmxxzd) = eebtlkqixb gpvvnxmqge (ioqoomugxi, 113.87) View more |