FLUDROCORTISONE ACETATE
FLUDROCORTISONE ACETATE is indicated for the treatment of Adrenocortical Insufficiency; Addison's Disease; Adrenogenital Syndrome.
Details
- Status
- Discontinued
- First Approved
- 2002-03-18
- Routes
- ORAL
- Dosage Forms
- TABLET
FLUDROCORTISONE ACETATE Approval History
What FLUDROCORTISONE ACETATE Treats
3 indicationsFLUDROCORTISONE ACETATE is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Addison's Disease
- Adrenogenital Syndrome
FLUDROCORTISONE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FLUDROCORTISONE ACETATE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06136650 | 5684-004 MK-5684-004, jRCT2031240030 | Ph 3 | 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) |
| NCT06136624 OMAHA-003 | 5684-003 2023-504899-25-00, MK-5684-003 | Ph 3 | recruiting | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) |
| NCT07548606 | 5684-017 MK-5684-017 | Ph 1 | recruiting | A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) |
| NCT06104449 | 5684-005 MK-5684-005, jRCT2031230431 | Ph 1 | completed | A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) |
| NCT06353386 | 5684-01A MK-5684-01A, 2023-506288-33-00 | Ph 1, Ph 2 | 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) |
| NCT06860243 | 5684-009 MK-5684-009 | Ph 1 | completed | A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009) |
| NCT06814132 | 5684-010 MK-5684-010, CA43216 | Ph 1 | 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) |
| NCT06633419 | 5684-012 MK-5684-012 | Ph 1 | completed | A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012) |
| NCT06554639 | 5684-011 MK-5684-011 | Ph 1 | completed | A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011) |
| NCT04494789 FluDReSS | GI-CC35837377 | Ph 2 | completed | Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLUDROCORTISONE ACETATE FDA Label Details
Indications & Usage
FLUDROCORTISONE ACETATE is indicated for the treatment of Adrenocortical Insufficiency; Addison's Disease; Adrenogenital Syndrome.
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FLORINEF
Full clinical data, patents, trials, and competitive landscape for fludrocortisone acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.