Fludrocortisone
- Generic Name
- Fludrocortisone
- Brand Names
- Florinef
- Drug Type
- Small Molecule
- Chemical Formula
- C21H29FO5
- CAS Number
- 127-31-1
- Unique Ingredient Identifier
- U0476M545B
- Background
Fludrocortisone is a synthetic mineralocorticoid used in conjunction with hydrocortisone to replace missing endogenous corticosteroids in patients with adrenal insufficiency. It is functionally similar to aldosterone, the body's primary endogenous mineralocorticoid, and is structurally analogous to cortisol, differing only by a fluorine atom at the 9-position of the steroid structure - this fluorination is thought to be crucial to fludrocortisone's significant mineralocorticoid potency.
- Indication
Fludrocortisone is indicated as partial replacement therapy for primary or secondary adrenocortical insufficiency in Addison's disease. It is also indicated for the treatment of salt-losing androgenital syndrome.
- Associated Conditions
- Otitis Externa, Otitis Media (OM), Primary adrenocortical insufficiency, Secondary adrenocortical insufficiency, Salt-losing Androgenital syndrome
A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)
- Conditions
- Hepatic ImpairmentHealthy Participants
- Interventions
- First Posted Date
- 2025-03-05
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 16
- Registration Number
- NCT06860243
- Locations
- 🇺🇸
Clinical Pharmacology of Miami ( Site 0002), Miami, Florida, United States
🇺🇸Texas Liver Institute ( Site 0001), San Antonio, Texas, United States
Ramadan Fasting Outcomes in Patients with Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.
- Conditions
- Secondary Adrenal InsufficiencyHypotension
- Interventions
- First Posted Date
- 2025-02-18
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- Hopital La Rabta
- Target Recruit Count
- 20
- Registration Number
- NCT06832566
- Locations
- 🇹🇳
Hopital La Rabta, Tunis, Tunisia
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
- Conditions
- Kidney Failure, ChronicEnd-Stage Kidney DiseaseRenal Failure, ChronicRenal Failure, End-StageHealthy Participants
- Interventions
- First Posted Date
- 2025-02-07
- Last Posted Date
- 2025-05-12
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 24
- Registration Number
- NCT06814132
- Locations
- 🇺🇸
Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States
🇺🇸Research by Design ( Site 0001), Chicago, Illinois, United States
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
- Conditions
- Pharmacodynamic
- Interventions
- First Posted Date
- 2024-10-18
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Santhera Pharmaceuticals
- Target Recruit Count
- 30
- Registration Number
- NCT06649409
- Locations
- 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany
A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2024-10-09
- Last Posted Date
- 2025-04-17
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 14
- Registration Number
- NCT06633419
- Locations
- 🇺🇸
Celerion ( Site 0001), Tempe, Arizona, United States
A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)
- Conditions
- Metastatic Prostate Cancer
- Interventions
- First Posted Date
- 2024-08-22
- Last Posted Date
- 2024-10-23
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 8
- Registration Number
- NCT06566989
- Locations
- 🇬🇧
Quotient Sciences ( Site 0001), Nottingham, Nottinghamshire, United Kingdom
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)
- Conditions
- Prostatic Neoplasms
- Interventions
- First Posted Date
- 2024-08-15
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 12
- Registration Number
- NCT06554639
- Locations
- 🇺🇸
Celerion ( Site 0001), Tempe, Arizona, United States
FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-05-10
- Last Posted Date
- 2024-08-16
- Lead Sponsor
- The George Institute
- Target Recruit Count
- 524
- Registration Number
- NCT06409364
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)
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- First Posted Date
- 2024-04-09
- Last Posted Date
- 2025-05-11
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 220
- Registration Number
- NCT06353386
- Locations
- 🇹🇷
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800), Ankara, Turkey
🇺🇸UCSD Moores Cancer Center ( Site 0039), La Jolla, California, United States
🇺🇸UCLA Hematology/Oncology - Santa Monica ( Site 0044), Los Angeles, California, United States
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
- Conditions
- Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer
- Interventions
- First Posted Date
- 2023-11-18
- Last Posted Date
- 2025-04-04
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 14
- Registration Number
- NCT06136598
- Locations
- 🇨🇳
Peking University First Hospital-Urology ( Site 0001), Beijing, Beijing, China
🇨🇳Tongji Hospital Tongji Medical,Science & Technology ( Site 0002), Wuhan, Hubei, China
🇨🇳Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003), Guangzhou, Guangdong, China
Drug Development Updates
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