Fludrocortisone

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009)	2025/03/05	NCT06860243	Phase 1	Recruiting	Merck Sharp & Dohme LLC
Ramadan Fasting Outcomes in Patients with Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.	2025/02/18	NCT06832566	Phase 4	Not yet recruiting	Hopital La Rabta
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)	2025/02/07	NCT06814132	Phase 1	Recruiting	Merck Sharp & Dohme LLC
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects	2024/10/18	NCT06649409	Phase 1	Completed	Santhera Pharmaceuticals
A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)	2024/10/09	NCT06633419	Phase 1	Completed	Merck Sharp & Dohme LLC
A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)	2024/08/22	NCT06566989	Phase 1	Completed	Merck Sharp & Dohme LLC
A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011)	2024/08/15	NCT06554639	Phase 1	Completed	Merck Sharp & Dohme LLC
FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage	2024/05/10	NCT06409364	Phase 2	Not yet recruiting	The George Institute
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)	2024/04/09	NCT06353386	Phase 1	Recruiting	Merck Sharp & Dohme LLC
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)	2023/11/18	NCT06136650	Phase 3	Active, not recruiting	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FLUDROCORTISONE ACETATE	AvPAK	50268-330	ORAL	0.1 mg in 1 1	1/9/2024
Fludrocortisone Acetate	Amneal Pharmaceuticals NY LLC	69238-7033	ORAL	0.1 mg in 1 1	2/9/2024
Fludrocortisone Acetate	American Health Packaging	68084-288	ORAL	0.1 mg in 1 1	1/20/2023
Fludrocortisone Acetate	Amneal Pharmaceuticals of New York LLC	0115-7033	ORAL	0.1 mg in 1 1	1/6/2024
Fludrocortisone Acetate	NorthStar Rx LLC	72603-170	ORAL	0.1 mg in 1 1	9/7/2023
Fludrocortisone Acetate	NCS HealthCare of KY, Inc dba Vangard Labs	0615-6562	ORAL	0.1 mg in 1 1	11/3/2020
Fludrocortisone Acetate	AvKARE	42291-764	ORAL	0.1 mg in 1 1	1/10/2024
Fludrocortisone Acetate	Teva Pharmaceuticals USA, Inc.	0555-0997	ORAL	0.1 mg in 1 1	11/30/2019
Fludrocortisone Acetate	Physicians Total Care, Inc.	54868-5446	ORAL	0.1 mg in 1 1	9/3/2010
Fludrocortisone Acetate	Bryant Ranch Prepack	63629-8806	ORAL	0.1 mg in 1 1	11/1/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FLORINEF TABLET 0.1 mg	Haupt Pharma Amareg GmbH	SIN10680P	TABLET	0.1 mg	1/20/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FLORINEF fludrocortisone 0.1mg tablet bottle	54688	Aspen Pharmacare Australia Pty Ltd	Medicine	A	3/19/1996
FLUDROCORTISONE MEDICIANZ fludrocortisone acetate 100 microgram tablet blister	346714	Medsurge Pharma Pty Ltd	Medicine	A	9/10/2021
FLUDROCORTISONE MEDSURGE fludrocortisone acetate 100 microgram tablet blister	346713	Medsurge Pharma Pty Ltd	Medicine	A	9/10/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ASTONIN 0,1 mg COMPRIMIDOS	Laboratorios Ern S.A.	48921	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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