> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/fludrocortisone-acetate-86ac4ece-968a-47e6-a7c4-a66d7488601a > Record changed: 2026-10-13 # Fludrocortisone acetate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) First approval year 1955 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) ## Development status **First approval year** 1955 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **Drug name** Fludrocortisone acetate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **Molecular weight** 422.49 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **Structure (SMILES)** CC(=O)OCC(=O)\[C@@\]1(O)CC\[C@H\]2\[C@@H\]3CCC4=CC(=O)CC\[C@\]4(C)\[C@@\]3(F)\[C@@H\](O)C\[C@@\]21C Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) ### Brand names (10) - astonin - Astonin - florinef - Florinef - fludrocortisone acetate - Fludrocortisone acetate - fludrocortone - Fludrocortone - panotile - Panotile ### Other names (36) - fludrocortisona - Fludrocortisona - fludrocortisone 21 acetate - fludrocortisone 21 acetate mi - Fludrocortisone 21-acetate - FLUDROCORTISONE 21-ACETATE \[MI\] - fludrocortisone acetate - Fludrocortisone acetate - FLUDROCORTISONE ACETATE \[EP MONOGRAPH\] - FLUDROCORTISONE ACETATE \[JAN\] - FLUDROCORTISONE ACETATE \[MART.\] - FLUDROCORTISONE ACETATE \[ORANGE BOOK\] - FLUDROCORTISONE ACETATE \[USP MONOGRAPH\] - FLUDROCORTISONE ACETATE \[USP-RS\] - FLUDROCORTISONE ACETATE \[VANDF\] - Fludrocortisone acetate \[WHO-DD\] - FLUDROCORTISONE ACETATE \[WHO-IP\] - fludrocortisone acetate ep monograph - fludrocortisone acetate jan - fludrocortisone acetate mart - fludrocortisone acetate orange book - fludrocortisone acetate usp monograph - fludrocortisone acetate usp rs - fludrocortisone acetate vandf - fludrocortisone acetate who dd And 11 more, listed on the interactive page. ## Identifiers **ATC classification codes** - H02AA02 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **CAS registry numbers** - 514-36-3 **ChEMBL ID** CHEMBL1201010 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **InChIKey** SYWHXTATXSMDSB-GSLJADNHSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201010) **PubChem compound IDs** - 225609 **RxNorm IDs (RxCUI)** - 165516 **FDA ingredient codes (UNII)** - V47IF0PVH4 ## Regulatory information ### United States **Applicant** CASPER PHARMA LLC **Approval date** 18 Aug 1955 **Application number** NDA010060 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** fludrocortisone **Type** Synthetic organic **Drug name stem** \-cort- #### Administration routes - Oral ### Mechanisms of action - **Mechanism** Mineralocorticoid receptor agonist **Action type** Agonist **Target** Mineralocorticoid receptor **Protein identifier** P08235 ### Open Targets mechanisms - **Mechanism** Mineralocorticoid receptor agonist **Action type** Agonist **Target** Mineralocorticoid receptor ### DrugCentral mechanisms - **Action type** Agonist **Gene symbol** NR3C2 **Protein identifier** P08235 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (15) - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000196 **Subject identifier** D011471 - **Condition** Prostatic Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000673 **Subject identifier** D011471 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0000694 **Subject identifier** D045169 - **Condition** Subarachnoid Hemorrhage **Highest recorded phase** 2 **Condition identifier** EFO:0000713 **Subject identifier** D013345 - **Condition** Melanoma **Highest recorded phase** 2 **Condition identifier** EFO:0000756 **Subject identifier** D008545 - **Condition** Shock, Septic **Highest recorded phase** 3 **Condition identifier** EFO:0006834 **Subject identifier** D012772 - **Condition** Hearing Loss, Sensorineural **Highest recorded phase** 0.5 **Condition identifier** EFO:1001176 **Subject identifier** D006319 - **Condition** Depressive Disorder **Highest recorded phase** 1 **Condition identifier** MONDO:0002050 **Subject identifier** D003866 - **Condition** Parkinson Disease **Highest recorded phase** 2 **Condition identifier** MONDO:0005180 **Subject identifier** D010300 - **Condition** Ovarian Hyperstimulation Syndrome **Highest recorded phase** 2 **Condition identifier** MONDO:0011972 **Subject identifier** D016471 - **Condition** Addison Disease **Highest recorded phase** 4 **Condition identifier** MONDO:0015128 **Subject identifier** D000224 - **Condition** Addison Disease **Highest recorded phase** 4 **Condition identifier** MONDO:0015129 **Subject identifier** D000224 - **Condition** Adrenogenital Syndrome **Highest recorded phase** 4 **Condition identifier** MONDO:0015898 **Subject identifier** D047808 - **Condition** Adrenal Hyperplasia, Congenital **Highest recorded phase** 2 **Condition identifier** MONDO:0018479 **Subject identifier** D000312 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** MONDO:0100096 **Subject identifier** D045169 ### Open Targets indications (19) - **Condition identifier** EFO\_0000673 - **Condition identifier** EFO\_0000694 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000713 **Highest recorded phase** 2 - **Condition identifier** EFO\_0006834 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001176 - **Condition identifier** MONDO\_0002050 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005180 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005469 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008315 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0015128 - **Condition identifier** MONDO\_0015128 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0015129 - **Condition identifier** MONDO\_0015129 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0015898 - **Condition identifier** MONDO\_0015898 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0018479 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018479 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0043373 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0100096 **Highest recorded phase** 3 ### Reported adverse events (55) - **Event** accelerated hypertension **Reports** 3 **Reporting signal score** 12.8505 - **Event** acute psychosis **Reports** 11 **Reporting signal score** 41.1174 - **Event** adrenal insufficiency **Reports** 8 **Reporting signal score** 17.5655 - **Event** adrenocortical insufficiency acute **Reports** 11 **Reporting signal score** 48.8213 - **Event** androgen deficiency **Reports** 3 **Reporting signal score** 14.6357 - **Event** asthenia **Reports** 21 **Reporting signal score** 7.56381 - **Event** autonomic failure syndrome **Reports** 2 **Reporting signal score** 12.5619 - **Event** blood pressure increased **Reports** 12 **Reporting signal score** 8.60557 - **Event** cerebral hypoperfusion **Reports** 4 **Reporting signal score** 18.85 - **Event** cerebrovascular accident **Reports** 50 **Reporting signal score** 88.5132 - **Event** cognitive disorder **Reports** 11 **Reporting signal score** 15.9003 - **Event** confusional state **Reports** 22 **Reporting signal score** 20.4421 - **Event** dehydration **Reports** 7 **Reporting signal score** 6.65963 - **Event** dermatitis bullous **Reports** 7 **Reporting signal score** 15.5324 - **Event** disorientation **Reports** 16 **Reporting signal score** 28.3701 - **Event** dizziness **Reports** 31 **Reporting signal score** 13.2928 - **Event** dizziness postural **Reports** 4 **Reporting signal score** 8.406 - **Event** dyskinesia **Reports** 11 **Reporting signal score** 17.673 - **Event** dystonia **Reports** 13 **Reporting signal score** 30.491 - **Event** electrocardiogram qrs complex prolonged **Reports** 4 **Reporting signal score** 8.71816 - **Event** eosinophilic oesophagitis **Reports** 7 **Reporting signal score** 34.4379 - **Event** executive dysfunction **Reports** 3 **Reporting signal score** 13.601 - **Event** fall **Reports** 26 **Reporting signal score** 13.8349 - **Event** foaming at mouth **Reports** 3 **Reporting signal score** 9.94516 - **Event** glomerulonephritis membranous **Reports** 5 **Reporting signal score** 18.5812 And 30 more, listed on the interactive page. ### Trial references (18) - NCT00320099 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00320099) - NCT00625209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00625209) - NCT02069288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02069288) - NCT04494789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04494789) - NCT05001854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05001854) - NCT00623766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00623766) - NCT01186185 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01186185) - NCT01648998 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01648998) - NCT01993680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01993680) - NCT03548246 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03548246) - NCT04351126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04351126) - NCT05453214 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453214) - NCT06104449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06104449) - NCT06136598 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06136598) - NCT06136650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06136650) - NCT06353386 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06353386) - NCT06136624 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06136624) - NCT06409364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06409364) ## Dosing **Dose** 0.1 mg **Route** Oral **How often** Once daily ### Conditions of use - Patient response influences dosage ## Chemical properties **Hydrogen bond acceptors** 6 **Hydrogen bond donors** 2 **Polar surface area** 100.9 **Calculated partition coefficient (ALogP)** 2.44 **Calculated partition coefficient (XLogP)** 1.7 **Prodrug** Yes **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 3 **Heavy atoms** 30 **Molecular formula** C23H31FO6 **Monoisotopic mass** 422.21046687 **Natural product** No ## National Drug Codes - 0115-7033 - 0615-6562 - 0904-7317 - 42291-764 - 50268-330 - 51407-705 - 68084-288 - 70954-252 - 71930-088 - 72578-164 - 72603-170 - 55154-2644 - 55154-6645 - 69238-7033 - 70771-1893 - 71335-2454 ## Evidence counts **Recorded assays** 747 **Active assays** 5 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Anti-Inflammatory Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000893.html) ## Related records ### Trials (14) - A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012) - A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011) - A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) - A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) - A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) - [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)](https://trialight.com/data/trial/a-study-of-opevesostat-mk-5684-versus-alternative-next-40ece519-da89-4905-86a7-0c1a844d57e4.md) - A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009) - 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) - Clinical Trial for the Prevention of Vasovagal Syncope - Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS - Midodrine and Fludrocortisone for Vasovagal Syncope - Mineralocorticoid Use in COVID-19 Patients - [Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)](https://trialight.com/data/trial/study-of-opevesostat-mk-5684-versus-alternative-nha-in-mcrpc-332ed2a7-4705-40a6-a799-b3905fd1df96.md) - 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) ### Approved for (3) - Adrenogenital syndrome - Chronic primary adrenal insufficiency - Primary adrenal insufficiency ### In development for (12) - Congenital adrenal hyperplasia Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 1 - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 2 - [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 3 - Ovarian hyperstimulation syndrome Phase 2 - [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) Phase 2 - [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md) Phase 3 - Sensorineural hearing loss disorder Early phase 1 - [Severe acute respiratory syndrome](https://trialight.com/data/condition/severe-acute-respiratory-syndrome-7654d02a-f750-52a0-bec2-afe3b4b3c224.md) Phase 3 - Subarachnoid hemorrhage Phase 2 - Toxic shock syndrome Phase 3 ### Targets (1) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) Mineralocorticoid receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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