Fludrocortisone Acetate
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Also known as AstoninFlorinefFludrocortisonaFludrocortisoni acetasFluorocortisol acetateFludrocortoneNSC-15186PanotileScherofluronfludrocortisone
Summary
Fludrocortisone Acetate (CHEMBL1201010) is an approved small molecule (ATC H02AA02); indicated across 15 conditions including chronic primary adrenal insufficiency and adrenogenital syndrome.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: H02AA02
- Indications: 15 conditions
- Clinical trials: 45
- Chemistry: 422.5 Da · C23H31FO6
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201010 |
| Name | Fludrocortisone Acetate |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 225609 |
| ChEBI | CHEBI:5102 |
| ATC | H02AA02 |
| Molecular formula | C23H31FO6 |
| Molecular weight | 422.5 |
| InChIKey | SYWHXTATXSMDSB-GSLJADNHSA-N |
SMILES: CC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2CCC4=CC(=O)CC[C@@]43C)F)O)C)O
IUPAC name: [2-[(8S,9R,10S,11S,13S,14S,17R)-9-fluoro-11,17-dihydroxy-10,13-dimethyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
ChEBI definition: An acetate ester resulting from the formal condensation of the primary hydroxy group of fludrocortisone with acetic acid. A synthetic corticosteroid, it has glucocorticoid actions about 10 times as potent as hydrocortisone, while its mineralocorticoid actions are over 100 times as potent. It is used in partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenal hyperplasia.
Also known as: Astonin, Florinef, Fludrocortisona, Fludrocortisone acetate, Fludrocortisoni acetas, Fluorocortisol acetate, Fludrocortone, NSC-15186, Panotile, Scherofluron, Fludrocortisone Acetate, FLUDROCORTISONE ACETATE
Patent coverage: 2,323 distinct patent families (9,828 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 3 (assay-derived). Sample: Glucocorticoid receptor, Progesterone receptor, Histamine H1 receptor.
Bioactivity
ChEMBL activities: 4 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):
| Target | pChembl | Type | Value | Unit | Activity ID |
|---|---|---|---|---|---|
| NR3C1 | 8.03 | Ki | 9.25 | nM | CHEMBL_ACT_7657090 |
| NR3C1 | 7.7 | IC50 | 20 | nM | CHEMBL_ACT_7657089 |
| NR3C1 | 6.6 | AC50 | 250 | nM | CHEMBL_ACT_25176118 |
| PGR | 5.09 | AC50 | 8200 | nM | CHEMBL_ACT_25223267 |
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
15 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| chronic primary adrenal insufficiency | 4 | MONDO:0015129 | MONDO:0015128 |
| adrenogenital syndrome | 4 | MONDO:0015898 | MONDO:0015898 |
| toxic shock syndrome | 3 | MONDO:0001881 | EFO:0006834 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | EFO:0000694 |
| metastatic prostate carcinoma | 3 | MONDO:0004956 | EFO:0000196 |
| prostate adenocarcinoma | 3 | MONDO:0005082 | EFO:0000673 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| Parkinson disease | 2 | MONDO:0005180 | MONDO:0005180 |
| ovarian hyperstimulation syndrome | 2 | MONDO:0011972 | MONDO:0011972 |
| congenital adrenal hyperplasia | 2 | MONDO:0018479 | MONDO:0018479 |
| subarachnoid hemorrhage | 2 | MONDO:0005099 | EFO:0000713 |
| depressive disorder | 1 | MONDO:0002050 | MONDO:0002050 |
| sensorineural hearing loss disorder | 0 | MONDO:0020678 | EFO:1001176 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 45.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE1 | 12 |
| PHASE2 | 11 |
| PHASE3 | 9 |
| Not specified | 5 |
| PHASE4 | 4 |
| PHASE1/PHASE2 | 2 |
| PHASE2/PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06832566 | PHASE4 | NOT_YET_RECRUITING | Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension. |
| NCT00118482 | PHASE4 | COMPLETED | Clinical Trial for the Prevention of Vasovagal Syncope |
| NCT01453959 | PHASE4 | UNKNOWN | Fludrocortisone’s Test in Salt Sensitivity |
| NCT04128137 | PHASE4 | UNKNOWN | Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension |
| NCT06136624 | PHASE3 | RECRUITING | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) |
| NCT06136650 | PHASE3 | RECRUITING | 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) |
| NCT00001521 | PHASE3 | COMPLETED | Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia |
| NCT00320099 | PHASE3 | COMPLETED | Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock |
| NCT00625209 | PHASE3 | COMPLETED | Activated Protein C and Corticosteroids for Human Septic Shock |
| NCT01093261 | PHASE3 | COMPLETED | Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury |
| NCT02069288 | PHASE3 | WITHDRAWN | Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock |
| NCT04595942 | PHASE3 | UNKNOWN | Midodrine and Fludrocortisone for Vasovagal Syncope |
| NCT05001854 | PHASE2/PHASE3 | SUSPENDED | Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients |
| NCT05453214 | PHASE3 | COMPLETED | Mineralocorticoid Use in COVID-19 Patients |
| NCT06353386 | PHASE1/PHASE2 | RECRUITING | 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) |
| NCT06381661 | PHASE2 | NOT_YET_RECRUITING | Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial |
| NCT06409364 | PHASE2 | RECRUITING | FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage |
| NCT06979596 | PHASE2 | RECRUITING | A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) |
| NCT07451886 | PHASE2 | NOT_YET_RECRUITING | Adjunctive Fludrocortisone in Septic Shock |
| NCT00623766 | PHASE2 | COMPLETED | Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases |
| NCT00673270 | PHASE1/PHASE2 | TERMINATED | Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression |
| NCT01993680 | PHASE2 | COMPLETED | Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson’s Disease -Treatment |
| NCT02140918 | PHASE2 | COMPLETED | Fludrocortisone in Healthy Volunteers (AFLUCO4) |
| NCT03001089 | PHASE2 | COMPLETED | Impact of the Administration of Fludrocortisone in Very Premature Infants |
| NCT03548246 | PHASE2 | WITHDRAWN | Androgen Reduction in Congenital Adrenal Hyperplasia |
| NCT04351126 | PHASE2 | COMPLETED | Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response |
| NCT04494789 | PHASE2 | COMPLETED | Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS |
| NCT07548606 | PHASE1 | ACTIVE_NOT_RECRUITING | A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) |
| NCT00103597 | PHASE1 | COMPLETED | Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson’s Disease and Multiple System Atrophy |
| NCT01648998 | PHASE1 | COMPLETED | Fludrocortisone and Information Processing in Healthy Volunteers |
| NCT02871648 | PHASE1 | COMPLETED | The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production |
| NCT06104449 | PHASE1 | COMPLETED | A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) |
| NCT06136598 | PHASE1 | COMPLETED | A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) |
| NCT06554639 | PHASE1 | COMPLETED | A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011) |
| NCT06566989 | PHASE1 | COMPLETED | A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008) |
| NCT06633419 | PHASE1 | COMPLETED | A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012) |
| NCT06649409 | PHASE1 | COMPLETED | Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects |
| NCT06814132 | PHASE1 | COMPLETED | 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) |
| NCT06860243 | PHASE1 | COMPLETED | A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009) |
| NCT01186185 | EARLY_PHASE1 | TERMINATED | Fludrocortisone for Sudden Hearing Loss |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).