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 · a red edge is where a trial was stopped
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Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 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 | 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 1/21 trial | ||||||
| Phase 1/2 | NCT06353386 Background | May 2024 → Jan 2029 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 26 trials | ||||||
| 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 35 trials | ||||||
| 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 | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | 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. 56 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 ↗45“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 “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 ↗ |