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Florinef

(Fludrocortisone)

ApprovedSmall molecule

Alnylam Pharmaceuticals

Fludrocortisone is used to treat conditions where the body doesn't produce enough of certain natural hormones, particularly adrenal insufficiency, and helps regulate salt and water balance in the body.[2] Florinef is currently approved and in use across 11 indications[4].[1]

Florinef is one of 303 small molecule programs targeting Aneurysm. It is currently in Approved.

11

Indications

26

Total Trials

3

Active Trials

302

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AneurysmActive, not recruiting

Borderline Personality DisorderActive, not recruiting

Hearing LossActive, not recruiting

SepsisActive, not recruiting

CognitionActive, not recruiting

Septic ShockActive, not recruiting

Prostate CancerActive, not recruiting

HypotensionActive, not recruiting

Congenital Adrenal HyperplasiaActive, not recruiting

Type 1 Diabetes MellitusActive, not recruiting

AneurysmPhase 2

Active, not recruiting

Borderline Personality DisorderPreclinical

Active, not recruiting

Hearing LossPhase 1

Active, not recruiting

SepsisPhase 2

Active, not recruiting

CognitionPreclinical

Active, not recruiting

Septic ShockPhase 3

Active, not recruiting

Prostate CancerPhase 1

Active, not recruiting

HypotensionApproved

Active, not recruiting

Congenital Adrenal HyperplasiaPhase 3

Active, not recruiting

Type 1 Diabetes MellitusPreclinical

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Florinef

Alnylam Pharmaceuticals

Mekinist

Trexall

Alnylam Pharmaceuticals

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Duragesic

Prednisone/prednisolone

Triptorelin Pamoate

Therapeutic Hydrocortisone

EEastern Cooperative Oncology Group

Osmitrol

BB. Braun Medical Inc.

Ifex

BBaxter Healthcare Corporation

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 2Not yet recruiting

Septic Shock

NCT07451886

Q3 2030

Phase 2Recruiting

Aneurysm

NCT06409364

Q2 2031

Phase 2Not yet recruiting

Sepsis

NCT06381661

Clinical

Trials by Indication[1]

Septic Shock4 trials

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

Suspended·RRennes University Hospital·Phase 2/3·NCT05001854·40 enrolled

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

Withdrawn·RRennes University Hospital·Phase 3·NCT02069288

Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

Completed·UUniversity of Versailles·Phase 3·NCT00320099·508 enrolled

Show 1 more trial

Adjunctive Fludrocortisone in Septic Shock

Not yet recruiting·—·Phase 2·NCT07451886·32 enrolled

Congenital Adrenal Hyperplasia2 trials

Androgen Reduction in Congenital Adrenal Hyperplasia

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT03548246

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00001521·66 enrolled

Hydrocortisone1 trial

Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

Terminated·RRennes University Hospital·Phase 1/2·NCT00673270·13 enrolled

Absorption1 trial

A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06566989·8 enrolled

ALD1 trial

The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production

Completed·—·Phase 1·NCT02871648·23 enrolled

15 more indications

Hearing Loss1 trial

Fludrocortisone for Sudden Hearing Loss

Terminated·OOregon Health and Science University·Phase 1·NCT01186185·5 enrolled

Prostate Cancer1 trial

A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06136598·14 enrolled

Multiple System Atrophy1 trial

Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy

Completed·—·Phase 1·NCT00103597·50 enrolled

Aneurysm1 trial

FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

Recruiting·TThe George Institute·Phase 2·NCT06409364·524 enrolled

Gastrointestinal Dysfunction1 trial

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

Completed·CChristian Baumann·Phase 2·NCT01993680·18 enrolled

Sepsis1 trial

Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06381661·2,000 enrolled

ESS1 trial

Fludrocortisone and Information Processing in Healthy Volunteers

Completed·LLeiden University Medical Center·Phase 1·NCT01648998·40 enrolled

Cognition1 trial

Stress & Social Cognition in BPD (part 2)

Completed·—·N/A·NCT05310253·240 enrolled

Type 1 Diabetes Mellitus1 trial

Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Withdrawn·VVanderbilt University·N/A·NCT00608101

Cognitive Function1 trial

Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression

Completed·—·N/A·NCT03062150·232 enrolled

Severe Depression1 trial

Mineralocorticoid Receptor in the Treatment of Severe Depression

Completed·UUniversitätsklinikum Hamburg-Eppendorf·N/A·NCT00295347·65 enrolled

Hypotension1 trial

Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

Unknown status·HH.A.C. PHARMA·Phase 4·NCT04128137·90 enrolled

Very Premature Infants1 trial

Impact of the Administration of Fludrocortisone in Very Premature Infants

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03001089·66 enrolled

Single Dose1 trial

A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02532998·40 enrolled

Unspecified3 trials

Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Completed·SSanthera Pharmaceuticals·Phase 1·NCT06649409·30 enrolled

Fludrocortisone's Test in Salt Sensitivity

Unknown status·FFundação de Amparo à Pesquisa do Estado de São Paulo·Phase 4·NCT01453959·40 enrolled

Fludrocortisone in Healthy Volunteers (AFLUCO4)

Completed·RRennes University Hospital·Phase 2·NCT02140918·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

FLORINEF

NDA NDA010060

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Fludrocortisone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Florinef drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fludrocortisone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fludrocortisone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA010060). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Alnylam Pharmaceuticals

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