Drugs / Fludrocortisone
Fludrocortisone
also known as
Fludrocortisone Acetate · 9 alpha fludrocortisone · 9α fluoro-hydrocortisone · Astonin H · Cortilon
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FLORINEF | — | 1955-08-18 | fda.gov ↗ |
Trials 31
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01186185 | Aug 2012 → Mar 2016 | sensorineural hearing loss disorder | Oregon Health and Science University | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01648998 | May 2012 → Jun 2013 | depressive disorder | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00103597 | Jan → Sep 2005 | Parkinson disease, multiple system atrophy, orthostatic hypotension | Royal Brisbane and Women's Hospital | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00673270 | May → Oct 2008 | hypertensive disorder | Rennes University Hospital | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06381661 | May 2026 → Jun 2028 expected | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07451886 | Apr 2026 → Jul 2028 expected | infectious disease with sepsis | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT06409364 | Aug 2025 → Jul 2029 expected | acquired aneurysmal subarachnoid hemorrhage | The George Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04351126 | Apr 2019 → Feb 2020 | ovarian hyperstimulation syndrome | Ganin Fertility Center | Completed | No outcome recorded |
| Phase 2 | NCT03710187 | Nov 2018 → Sep 2019 | infectious disease with sepsis | University of Tennessee Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02140918 | Jul 2014 → Apr 2016 | — | Rennes University Hospital | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT05001854 | Mar 2022 → Jun 2024 | infectious disease with sepsis | Rennes University Hospital | Suspended | No outcome recorded |
| Phase 2/3 | NCT02919917 | Jun 2017 → Sep 2021 | autonomic dysreflexia, orthostatic hypotension, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | Missed primary |
| Phase 37 trials · 2 missed | ||||||
| Phase 3 | NCT07037043 | Apr 2025 → May 2028 expected | — | Centre Hospitalier Universitaire, Amiens | Recruiting | No outcome recorded |
| Phase 3 | NCT04404400 | Feb 2022 → Feb 2026 overdue | adrenocortical insufficiency | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05453214 | Dec 2021 → Mar 2022 | COVID-19, acute respiratory distress syndrome | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT03773822 | Apr 2019 → Apr 2023 | cardiogenic shock | CMC Ambroise Paré | Completed | No outcome recorded |
| Phase 3 | NCT01093261 | Aug 2010 → Nov 2012 | adrenocortical insufficiency, pneumonia, traumatic brain injury | Nantes University Hospital | Completed | Missed primary |
| Phase 3 | NCT00320099 | Jan 2006 → Jan 2009 | infectious disease with sepsis | University of Versailles | Completed | Missed primary |
| Phase 3 | NCT02069288 | ? → Feb 2014 | infectious disease with sepsis | Rennes University Hospital | Withdrawn | No outcome recorded |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT07383103 | Mar 2026 → Dec 2028 expected | infectious disease with sepsis | Northern Jiangsu People's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06832566 | Feb → Apr 2025 overdue | hypotensive disorder, secondary adrenal insufficiency | Hopital La Rabta | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04128137 | Jul 2020 → Jun 2024 | orthostatic hypotension | H.A.C. PHARMA | Unknown | No outcome recorded |
| Phase 4 | NCT04492280 | Sep 2018 → Sep 2019 | infectious disease with sepsis | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT01453959 | Jul 2011 → Sep 2012 | hypertensive disorder | São Paulo Research Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT00118482 | May 2005 → Jul 2011 | neurally mediated hypotension | University of Calgary | Completed | Missed primary |
| Phase not applicable6 trials | ||||||
| — | NCT05440851 | Apr 2023 → Mar 2027 expected | respiratory failure | University Health Network, Toronto | Recruiting | No outcome recorded |
| — | NCT05310253 | Feb 2022 → Mar 2025 | borderline personality disorder | Charite University, Berlin, Germany | Completed | No outcome recorded |
| — | NCT04280497 | Apr 2020 → Dec 2025 overdue | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| — | NCT00608101 | Sep 2010 | type 1 diabetes mellitus | Vanderbilt University | Withdrawn | No outcome recorded |
| — | NCT00295347 | Dec 2005 → Jun 2008 | major depressive disorder | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| — | NCT00117585 | Nov 2005 → Sep 2008 | orthostatic hypotension | VA Office of Research and Development | Completed | No outcome recorded |
| Comparator or background therapy26 trials | ||||||
| Phase 1 | NCT07548606 Background | May → Jun 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06860243 Background | May 2025 → Feb 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06801236 Background | May 2025 → Dec 2028 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Acerand Therapeutics (Hong Kong) Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT06814132 Background | Apr → Oct 2025 | chronic renal failure syndrome, end stage renal failure | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06633419 Background | Dec 2024 → Feb 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06566989 Background | Sep → Oct 2024 | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06554639 Background | Jul → Aug 2024 | prostate neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06649409 Background | Jun 2024 | — | Santhera Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT06136598 Background | Jan 2024 → Mar 2026 | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06104449 Background | Nov 2023 → Feb 2026 | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02871648 Comparator | Jan 2016 → Oct 2019 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02532998 Background | Sep → Dec 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/2 | NCT06353386 Background | May 2024 → Jan 2029 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06979596 Background | Aug 2025 → Nov 2027 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT03548246 Background | Jan 2023 → Jan 2026 | classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04494789 Comparator | Feb 2021 → Apr 2023 | infectious disease with sepsis | The George Institute | Completed | No outcome recorded |
| Phase 2 | NCT03001089 Comparator | Jun 2017 → Sep 2020 | hypoaldosteronism disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01993680 Comparator | Jun 2012 → Apr 2015 | Parkinson disease | Christian Baumann | Completed | No outcome recorded |
| Phase 2 | NCT00623766 Background | Jul 2008 → Sep 2009 | melanoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT06136624 Background | Dec 2023 → Aug 2028 expected | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06136650 Background | Dec 2023 → May 2028 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04595942 Comparator | Nov 2020 → Oct 2023 | syncope, familial vasovagal | Tehran Heart Center | Unknown | No outcome recorded |
| Phase 3 | NCT00625209 Comparator | Mar 2008 → Jun 2015 | infectious disease with sepsis | University of Versailles | Completed | No outcome recorded |
| Phase 3 | NCT00001521 Background | Jun 1995 → Apr 2024 | congenital adrenal hyperplasia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | Missed primary |
| Phase 4 | NCT00368381 Comparator | Sep 2006 → Jul 2009 | adrenocortical insufficiency, infectious disease with sepsis | CAMC Health System | Withdrawn | No outcome recorded |
| — | NCT03062150 Comparator | Sep 2016 → Feb 2019 | major depressive disorder | Charite University, Berlin, Germany | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fludrocortisone | “These patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®) at dose of 50mg every 6 hours by Intra venous route and Fludrocortisone (Cortilon®,...” NCT04492280 ↗47“For the treatment group, hydrocortisone (50 mg intravenous bolus every 6 h) and fludrocortisone (50 μg once a day enterally) will be administered for 7 days or until discharge...” PMID 34980224 ↗ Jan 2022 “In each stratum, patients will be randomly assigned to receive a 7-day course of hydrocortisone and fludrocortisone or their placebos.” PMID 36898751 ↗ Mar 2023 “ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone.” NCT06801236 ↗ “Patients received either fludrocortisone or matching placebo at highest tolerated doses from 0.05 mg to 0.2 mg daily.” PMID 27364043 ↗ Jul 2016 “Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d” NCT02919917 ↗ “9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.” NCT04404400 ↗ “Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h” NCT03710187 ↗ “* Fludrocortisone * Salt tablet” NCT00117585 ↗ |
| Known as | 9 alpha fludrocortisone | “9 alpha fludrocortisone 50 μg: one tablet per day via a nasogastric tube.” NCT04404400 ↗ |
| Known as | 9α fluoro-hydrocortisone | “Fludrocortisone (9α fluoro-hydrocortisone) (FC) is a specific MR-agonist currently used to treat diseases of the adrenal cortex, septic shock (Russel, 2008) and occasionally...” NCT01648998 ↗ |
| Known as | Astonin H | “Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH” NCT03062150 ↗ |
| Known as | Cortilon | “These patients will receive standard therapy for sepsis plus Hydrocortisone (Solucortef®) at dose of 50mg every 6 hours by Intra venous route and Fludrocortisone (Cortilon®,...” NCT04492280 ↗ |
| Known as | Fludrocortisone Acetate | “Fludrocortisone/ Fludrocortisone acetate” NCT06979596 ↗ |
| Action | Restore | “Mineralocorticoid needed to replace aldosterone deficiency.” NCT00001521 ↗ |
| Modality | Small molecule | “Fludrocortisone acetate is a corticosteroid” NCT00118482 ↗ |
| Route | Oral | “fludrocortisone 100-200 mcg/day, depending on lab evaluation, orally” NCT00001521 ↗ |