Data updated: May 26, 2026
FLORINEF (fludrocortisone acetate)
Trial Activity: Stable 4 active trials
Endocrine
Approved 1955-08-18
Development Insights
Merck Sharp & Dohme LLC conducting 9 trials (75%)
14 indications explored (Broad Platform)
→ prostatic neoplasms (3 trials)
→ critically ill (3 trials)
→ septic shock (3 trials)
1
Indication
--
Phase 3 Trials
70
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1955-08-18
- Routes
- ORAL
- Dosage Forms
- TABLET
FLORINEF Approval History
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Original
New Indication
New Form
Label Update
9 FDA actions from 1955 to 2004
Aug 1999 SUPPL
Mfg · Manufacturing (CMC)
Mar 1995 SUPPL
Label · Labeling
Oct 1994 SUPPL
Mfg
Mar 1993 SUPPL
Label
May 1988 SUPPL
Label
Nov 1982 SUPPL
Label
Jan 1979 SUPPL
Mfg
Aug 1955 ORIGINAL
New Form
What FLORINEF Treats
1 FDA approvalsOriginally approved for its first indication in 1955 .
- Other (1)
Other
(1 approval)- • Approved indication (Aug 1955)
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
FLORINEF FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment