Fludrocortisone

Generic Name: Fludrocortisone

Brand Names: Florinef

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₉FO_₅

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

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)

Phase 3

Recruiting

Conditions: Prostatic Neoplasms
Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions: Drug: Abiraterone acetate
Drug: Opevesostat
Drug: Dexamethasone
Drug: Prednisone acetate
Drug: Fludrocortisone acetate
Drug: Enzalutamide
Drug: Hydrocortisone

First Posted Date: 2023-11-18

Last Posted Date: 2025-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1500

Registration Number: NCT06136650

Locations: 🇺🇸
The University of Arizona Cancer Center - North Campus ( Site 0073), Tucson, Arizona, United States
🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0044), Los Angeles, California, United States
🇺🇸
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040), Orange, California, United States

and more 305 locations

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Phase 3

Recruiting

Conditions: Prostate Cancer Metastatic

Interventions: Drug: Opevesostat
Drug: Abiraterone acetate
Drug: Hydrocortisone
Drug: Enzalutamide
Drug: Fludrocortisone acetate
Drug: Prednisone
Drug: Dexamethasone

First Posted Date: 2023-11-18

Last Posted Date: 2025-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1200

Registration Number: NCT06136624

Locations: 🇵🇪
Aliada-Oncologìa ( Site 1257), Lima, Peru
🇺🇸
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040), Orange, California, United States
🇺🇸
Stanford Cancer Center ( Site 0036), Palo Alto, California, United States

and more 276 locations

A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005)

Phase 1

Active, not recruiting

Conditions: Prostatic Neoplasms
Metastatic Castration-Resistant Prostate Cancer

Interventions: Drug: Opevesostat
Drug: Dexamethasone
Drug: Fludrocortisone acetate
Drug: Hydrocortisone

First Posted Date: 2023-10-27

Last Posted Date: 2024-05-20

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 6

Registration Number: NCT06104449

Locations: 🇯🇵
Yokohama City University Medical Center ( Site 0002), Yokohama, Kanagawa, Japan
🇯🇵
National Cancer Center Hospital East ( Site 0001), Kashiwa, Chiba, Japan
🇯🇵
Toho University Sakura Medical Center ( Site 0003), Sakura, Chiba, Japan

Mineralocorticoid Use in COVID-19 Patients

Phase 3

Completed

Conditions: COVID-19
ARDS

Interventions: Drug: Fludrocortisone Acetate 0.1 MG

First Posted Date: 2022-07-12

Last Posted Date: 2022-07-12

Lead Sponsor: Ain Shams University

Target Recruit Count: 10

Registration Number: NCT05453214

Locations: 🇪🇬
Ain Shams University, Cairo, Abbasia, Egypt

Stress & Social Cognition in BPD (part 2)

Not Applicable

Completed

Conditions: Borderline Personality Disorder

Interventions: Drug: Placebo
Drug: Fludrocortisone
Behavioral: Trier Social Stress Test (TSST)
Behavioral: Placebo Trier Social Stress Test (P-TSST)

First Posted Date: 2022-04-04

Last Posted Date: 2025-03-06

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 240

Registration Number: NCT05310253

Locations: 🇩🇪
Charite University, Berlin, Germany

Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients

Phase 2

Suspended

Conditions: Septic Shock

Interventions: Drug: Placebo
Drug: Fludrocortisone

First Posted Date: 2021-08-12

Last Posted Date: 2023-11-18

Lead Sponsor: Rennes University Hospital

Target Recruit Count: 40

Registration Number: NCT05001854

Locations: 🇫🇷
Rennes University Hospital - Intensive Care unit, Rennes, Bretagne, France

Midodrine and Fludrocortisone for Vasovagal Syncope

Phase 3

Conditions: Syncope, Vasovagal

Interventions: Drug: Fludrocortisone Acetate Tablets
Drug: Midodrine Hydrochloride Tablets
Behavioral: Lifestyle modification

First Posted Date: 2020-10-22

Last Posted Date: 2021-04-19

Lead Sponsor: Tehran Heart Center

Target Recruit Count: 1375

Registration Number: NCT04595942

Locations: 🇮🇷
Tehran Heart Center, Tehran, Iran, Islamic Republic of

Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS

Phase 2

Completed

Conditions: Critically Ill
Septic Shock

Interventions: Drug: Fludrocortisone Acetate
Other: Standard Therapy

First Posted Date: 2020-07-31

Last Posted Date: 2024-01-18

Lead Sponsor: The George Institute

Target Recruit Count: 155

Registration Number: NCT04494789

Locations: 🇦🇺
Blacktown Hospital, Sydney, New South Wales, Australia
🇦🇺
Austin Hospital, Melbourne, Victoria, Australia
🇦🇺
Royal North Shore Hospital, Sydney, New South Wales, Australia

and more 6 locations