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Fixed-duration Hydrocortisone
Fixed-duration hydrocortisone provides short-term glucocorticoid replacement or anti-inflammatory effects with a predetermined treatment duration to minimize long-term steroid exposure.
Fixed-duration hydrocortisone provides short-term glucocorticoid replacement or anti-inflammatory effects with a predetermined treatment duration to minimize long-term steroid exposure. Used for Adrenal insufficiency or critical illness-related corticosteroid insufficiency (investigational fixed-duration regimen).
At a glance
| Generic name | Fixed-duration Hydrocortisone |
|---|---|
| Sponsor | UMC Utrecht |
| Drug class | Glucocorticoid |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Hydrocortisone is a glucocorticoid that binds to glucocorticoid receptors in the cytoplasm, translocating to the nucleus to modulate gene expression and suppress inflammatory and immune responses. The 'fixed-duration' formulation is designed to deliver therapeutic glucocorticoid effects over a defined treatment period, reducing cumulative steroid burden and associated long-term adverse effects compared to indefinite corticosteroid therapy.
Approved indications
- Adrenal insufficiency or critical illness-related corticosteroid insufficiency (investigational fixed-duration regimen)
Common side effects
- Hyperglycemia
- Hypertension
- Hypokalemia
- Immunosuppression / increased infection risk
- Insomnia
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance (PHASE4)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (PHASE1)
- Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre (NA)
- 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) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fixed-duration Hydrocortisone CI brief — competitive landscape report
- Fixed-duration Hydrocortisone updates RSS · CI watch RSS
- UMC Utrecht portfolio CI