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Fludrocortisone
Florinef (fludrocortisone) is a small molecule pharmaceutical. Fludrocortisone was first approved as Florinef on 1982-01-01. It is used to treat addison disease and adrenocortical hyperfunction in the USA. The pharmaceutical is active against mineralocorticoid receptor. In addition, it is known to target androgen receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
endocrine system diseasesD004700
immune system diseasesD007154
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fludrocortisone acetate
Tradename
Company
Number
Date
Products
FLORINEFCasper PharmaN-010060 DISCN1982-01-01
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
fludrocortisone acetateANDA2023-01-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
addison disease—D000224E27.1
adrenocortical hyperfunctionEFO_1000797D000308—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AA: Mineralocorticoids for systemic use, plain
— H02AA02: Fludrocortisone
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA06: Fludrocortisone and antiinfectives
— S02: Otologicals
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA07: Fludrocortisone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA05: Fludrocortisone and antiinfectives
HCPCS
No data
Clinical
Clinical Trials
30 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital adrenal hyperplasiaD000312E25.0—1—1—2
Vasovagal syncopeD019462R55——11—2
Orthostatic hypotensionD007024I95.11——1—2
HypertensionD006973EFO_0000537I10———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Septic shockD012772A48.3—24——5
Wounds and injuriesD014947T14.8——1——1
Traumatic brain injuriesD000070642S06——1——1
PneumoniaD011014EFO_0003106J18——1——1
Adrenal insufficiencyD000309——1——1
Covid-19D000086382U07.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—21———3
Parkinson diseaseD010300EFO_0002508G2011———2
MelanomaD008545—1———1
Ovarian hyperstimulation syndromeD016471—1———1
Critical illnessD016638—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sensorineural hearing lossD006319HP_0000407H90.51————1
DepressionD003863F33.91————1
Multiple system atrophyD0195781————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E10————11
IndividualityD007206————11
NephrolithiasisD053040N20.0————11
Renal tubular acidosisD000141N25.89————11
Borderline personality disorderD001883HP_0012076F60.3————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUDROCORTISONE
INNfludrocortisone
Description
Fludrocortisone is a C21-steroid, a 3-oxo-Delta(4) steroid, a 20-oxo steroid, a 21-hydroxy steroid, a fluorinated steroid, a mineralocorticoid, a 17alpha-hydroxy steroid and an 11beta-hydroxy steroid. It has a role as an adrenergic agent and an anti-inflammatory drug. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug classcortisone derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@]12C[C@H](O)[C@@]3(F)[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO
Identifiers
PDB1GS4
CAS-ID127-31-1
RxCUI4452
ChEMBL IDCHEMBL1201388
ChEBI ID50885
PubChem CID31378
DrugBankDB00687
UNII IDU0476M545B (ChemIDplus, GSRS)
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
4306
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Q96KQ9
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Alternate
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,594 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,074 adverse events reported
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