DeepMed Research

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

Androgen Reduction in Congenital Adrenal Hyperplasia

Phase 2

Withdrawn

Conditions: Congenital Adrenal Hyperplasia

Interventions: Drug: Placebo
Drug: Abiraterone acetate
Drug: Hydrocortisone
Drug: Fludrocortisone

First Posted Date: 2018-06-07

Last Posted Date: 2023-02-01

Lead Sponsor: University of Texas Southwestern Medical Center

Registration Number: NCT03548246

Locations: 🇺🇸
Children's Medical Center, Dallas, Texas, United States
🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
National Institutes of Health, Bethesda, Maryland, United States

and more 1 locations

Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression

Not Applicable

Completed

Conditions: Major Depression

Interventions: Drug: Placebo
Drug: Fludrocortisone
Drug: D-Cycloserine

First Posted Date: 2017-02-23

Last Posted Date: 2020-06-23

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 232

Registration Number: NCT03062150

Locations: 🇩🇪
Charité Universitätsmedizin Berlin, Berlin, Germany

Impact of the Administration of Fludrocortisone in Very Premature Infants

Phase 2

Completed

Conditions: Partial Mineralocorticoid Deficiency

Interventions: Drug: Oral Fludrocortisone (enteral)
Drug: Placebo Oral Tablet

First Posted Date: 2016-12-22

Last Posted Date: 2021-02-16

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 66

Registration Number: NCT03001089

Locations: 🇫🇷
Hôpital Robert Debré, Paris, France

The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Placebo
Drug: Fludrocortisone
Drug: Eplerenone

First Posted Date: 2016-08-18

Last Posted Date: 2021-06-08

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 23

Registration Number: NCT02871648

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Fludrocortisone in Healthy Volunteers (AFLUCO4)

Phase 2

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Placebo
Drug: Fludrocortisone 200 μg
Drug: Fludrocortisone 400 μg
Drug: Fludrocortisone 100 μg

First Posted Date: 2014-05-16

Last Posted Date: 2018-08-29

Lead Sponsor: Rennes University Hospital

Target Recruit Count: 16

Registration Number: NCT02140918

Locations: 🇫🇷
Rennes University Hospital, Rennes, France

Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock

Phase 3

Withdrawn

Conditions: Septic Shock

Interventions: Drug: Placebo
Drug: Fludrocortisone

First Posted Date: 2014-02-24

Last Posted Date: 2014-02-24

Lead Sponsor: Rennes University Hospital

Registration Number: NCT02069288

Locations: 🇫🇷
Service de Réanimation Chirurgicale - Hôpital de Pontchaillou, Rennes, France

Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment

Phase 2

Completed

Conditions: Autonomic Disturbances in Parkinson's Disease

Interventions: Drug: fludrocortisone
Drug: Pyridostigmine bromide

First Posted Date: 2013-11-25

Last Posted Date: 2021-01-25

Lead Sponsor: Christian Baumann

Target Recruit Count: 18

Registration Number: NCT01993680

Locations: 🇨🇭
University Hospital Zurich, Division of Neurology, Zurich, ZH, Switzerland

Fludrocortisone and Information Processing in Healthy Volunteers

Phase 1

Completed

Conditions: Depression

Interventions: Drug: Placebo
Drug: Fludrocortisone

First Posted Date: 2012-07-25

Last Posted Date: 2014-02-25

Lead Sponsor: Leiden University Medical Center

Target Recruit Count: 40

Registration Number: NCT01648998

Locations: 🇳🇱
Leiden University - Institute of Psychology, Leiden, Zuid-Holland, Netherlands

Fludrocortisone's Test in Salt Sensitivity

Phase 4

Conditions: Hypertension

Interventions: Other: Diet cycles
Drug: Fludrocortisone

First Posted Date: 2011-10-18

Last Posted Date: 2011-10-21

Lead Sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo

Target Recruit Count: 40

Registration Number: NCT01453959

Locations: 🇧🇷
General Hospital of School of Medicine - Universiy of Sao Paulo, Sao Paulo, SP, Brazil

Fludrocortisone for Sudden Hearing Loss

Early Phase 1

Terminated

Conditions: Hearing Loss, Sensorineural

Interventions: Drug: Fludrocortisone

First Posted Date: 2010-08-23

Last Posted Date: 2019-10-18

Lead Sponsor: Oregon Health and Science University

Target Recruit Count: 5

Registration Number: NCT01186185

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy