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Hydrocortisone Fludrocortisone
This combination of hydrocortisone and fludrocortisone replaces deficient glucocorticoid and mineralocorticoid hormones to restore adrenal function.
This combination of hydrocortisone and fludrocortisone replaces deficient glucocorticoid and mineralocorticoid hormones to restore adrenal function. Used for Septic shock with adrenal insufficiency, Critical illness-related corticosteroid insufficiency (CIRCI).
At a glance
| Generic name | Hydrocortisone Fludrocortisone |
|---|---|
| Sponsor | Nantes University Hospital |
| Drug class | Corticosteroid combination (glucocorticoid + mineralocorticoid) |
| Target | Glucocorticoid receptor (GR) and mineralocorticoid receptor (MR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Critical Care |
| Phase | Phase 3 |
Mechanism of action
Hydrocortisone is a glucocorticoid that suppresses inflammation and regulates metabolism, while fludrocortisone is a mineralocorticoid that promotes sodium retention and potassium excretion to maintain blood pressure and electrolyte balance. Together, they replace the hormonal deficiency seen in adrenal insufficiency or critical illness-related corticosteroid insufficiency (CIRCI).
Approved indications
- Septic shock with adrenal insufficiency
- Critical illness-related corticosteroid insufficiency (CIRCI)
Common side effects
- Hyperglycemia
- Hypokalemia
- Hypertension
- Infection (secondary)
- Gastrointestinal bleeding
Key clinical trials
- 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)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (PHASE3)
- A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) (PHASE1)
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) (PHASE1)
- Adjunctive Fludrocortisone in Septic Shock (PHASE2)
- Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock (PHASE4)
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
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 |