Florinef
(Fludrocortisone)ApprovedSmall molecule
Jazz PharmaceuticalsFludrocortisone 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 7 indications[4].[1]
Florinef is one of 223 small molecule programs targeting Aneurysm. It is currently in Approved.
7
Indications
29
Total Trials
5
Active Trials
222
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
100 competitors in Sepsis
#DrugCompanyPhaseTrials
1Florinef
Jazz PharmaceuticalsApproved
Dobutrex
PfizerPhase 2
Gleevec
NovartisPhase 2
Proamatine
TakedaPhase 2
Antibiotics
MMelinta Therapeutics, Inc.
Phase 3
N-Acetylcysteine (NAC) Treatment
TThe First Affiliated Hospital of Soochow University
Phase 3
G-CSF
AArog Pharmaceuticals, Inc.
Phase 2
Nafamostat Mesylate
EEnsysce Biosciences
Phase 3
Hydrocortisone Administration
UUniversity of Virginia
Phase 3
AZD4144
AstraZenecaPhase 2
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Septic Shock5 trials
Adjunctive Fludrocortisone in Septic Shock
Not yet recruiting·—·Phase 2·NCT07451886·32 enrolled
Sepsis2 trials
Hypotension1 trial
16 more indications
Absorption1 trial
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
ALD1 trial
The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production
Completed·—·Phase 1·NCT02871648·23 enrolled
Gastrointestinal Dysfunction1 trial
Cognitive Function1 trial
Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression
Completed·—·N/A·NCT03062150·232 enrolled
Single Dose1 trial
Very Premature Infants1 trial
Cognition1 trial
Stress & Social Cognition in BPD (part 2)
Completed·—·N/A·NCT05310253·240 enrolled
Type 1 Diabetes Mellitus1 trial
Prostate Cancer1 trial
Metastatic Castration-Resistant Prostate Cancer1 trial
Unspecified3 trials
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
FLORINEF
NDA NDA010060
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Florinef drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Fludrocortisone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company