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Florinef (FLUDROCORTISONE ACETATE)
Florinef (generic name: FLUDROCORTISONE ACETATE) is a fludrocortisone Small molecule drug developed by Casper Pharma Llc. It is currently FDA-approved (first approved 1955) for Adrenogenital disorder, Primary adrenocortical insufficiency.
At a glance
| Generic name | FLUDROCORTISONE ACETATE |
|---|---|
| Sponsor | Casper Pharma Llc |
| Drug class | fludrocortisone |
| Target | Mineralocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 1955 |
Approved indications
- Adrenogenital disorder
- Primary adrenocortical insufficiency
Common side effects
- Muscle weakness
- Steroid myopathy
- Loss of muscle mass
- Osteoporosis
- Vertebral compression fractures
- Aseptic necrosis of femoral and humeral heads
- Pathologic fracture of long bones
- Spontaneous fractures
- Peptic ulcer with possible perforation and hemorrhage
- Pancreatitis
- Abdominal distention
- Ulcerative esophagitis
Drug interactions
- aripiprazole
- neostigmine
- pyridostigmine
- quetiapine
- rifabutin
- rifampicin
- rifapentine
- risperidone
Key clinical trials
- 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) (PHASE3)
- 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) (PHASE1,PHASE2)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (PHASE3)
- A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) (PHASE1)
- A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) (PHASE2)
- A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) (PHASE1)
- Adjunctive Fludrocortisone in Septic Shock (PHASE2)
- Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Florinef CI brief — competitive landscape report
- Florinef updates RSS · CI watch RSS
Frequently asked questions about Florinef
What is Florinef?
Florinef (FLUDROCORTISONE ACETATE) is a fludrocortisone drug developed by Casper Pharma Llc, indicated for Adrenogenital disorder, Primary adrenocortical insufficiency.
What is Florinef used for?
Florinef is indicated for Adrenogenital disorder, Primary adrenocortical insufficiency.
Who makes Florinef?
Florinef is developed and marketed by Casper Pharma Llc.
What is the generic name of Florinef?
FLUDROCORTISONE ACETATE is the generic (nonproprietary) name of Florinef.
What drug class is Florinef in?
Florinef belongs to the fludrocortisone class. See all fludrocortisone drugs at /class/fludrocortisone.
When was Florinef approved?
Florinef was first approved on 1955.
What development phase is Florinef in?
Florinef is FDA-approved (marketed).
What are the side effects of Florinef?
Common side effects of Florinef include Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads.
What does Florinef target?
Florinef targets Mineralocorticoid receptor and is a fludrocortisone.
Related
- Drug class: All fludrocortisone drugs
- Target: All drugs targeting Mineralocorticoid receptor
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Adrenogenital disorder
- Indication: Drugs for Primary adrenocortical insufficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing