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Fludrocortisone/ Fludrocortisone acetate
Fludrocortisone is a synthetic corticosteroid that acts as a mineralocorticoid receptor agonist, increasing sodium reabsorption and potassium excretion in the kidneys to regulate fluid and electrolyte balance.
Fludrocortisone is a synthetic corticosteroid that acts as a mineralocorticoid receptor agonist, increasing sodium reabsorption and potassium excretion in the kidneys to regulate fluid and electrolyte balance. Used for Adrenocortical insufficiency (Addison's disease), Salt-wasting syndrome, Orthostatic hypotension.
At a glance
| Generic name | Fludrocortisone/ Fludrocortisone acetate |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Mineralocorticoid receptor agonist; corticosteroid |
| Target | Mineralocorticoid receptor (MR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology; Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Fludrocortisone binds to mineralocorticoid receptors in the distal tubule and collecting duct of the nephron, promoting sodium retention and water reabsorption while enhancing potassium and hydrogen ion excretion. This leads to increased blood volume, elevated blood pressure, and correction of hyponatremia and hyperkalemia. It also possesses weak glucocorticoid activity, contributing to anti-inflammatory effects.
Approved indications
- Adrenocortical insufficiency (Addison's disease)
- Salt-wasting syndrome
- Orthostatic hypotension
- Hyponatremia
Common side effects
- Hypertension
- Hypokalemia
- Fluid retention / edema
- Headache
- Increased appetite
- Insomnia
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)
- Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) (PHASE1, PHASE2)
- 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)
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 |
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