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Fludrocortisone Acetate Tablets
Fludrocortisone Acetate Tablets is a Mineralocorticoid receptor agonist Small molecule drug developed by Tehran Heart Center. It is currently in Phase 3 development for Acute hypotension / shock, Adrenocortical insufficiency, Salt-wasting syndromes. Also known as: Florinef.
Fludrocortisone acetate is a synthetic mineralocorticoid that enhances sodium reabsorption and potassium excretion in the distal renal tubules, thereby increasing blood volume and blood pressure.
Fludrocortisone acetate is a synthetic mineralocorticoid that enhances sodium reabsorption and potassium excretion in the distal renal tubules, thereby increasing blood volume and blood pressure. Used for Acute hypotension / shock, Adrenocortical insufficiency, Salt-wasting syndromes.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Fludrocortisone Acetate Tablets |
|---|---|
| Also known as | Florinef |
| Sponsor | Tehran Heart Center |
| Drug class | Mineralocorticoid receptor agonist |
| Target | Mineralocorticoid receptor (MR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
As a mineralocorticoid receptor agonist, fludrocortisone acetate acts on the collecting duct of the kidney to promote sodium retention and water reabsorption while increasing urinary potassium loss. This leads to expansion of intravascular volume and elevation of blood pressure. It is used primarily in conditions characterized by aldosterone deficiency or severe hypotension.
Approved indications
- Acute hypotension / shock
- Adrenocortical insufficiency
- Salt-wasting syndromes
Common side effects
- Hypertension
- Hypokalemia
- Fluid retention / edema
- Headache
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 |
|---|---|
| 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:
- Fludrocortisone Acetate Tablets CI brief — competitive landscape report
- Fludrocortisone Acetate Tablets updates RSS · CI watch RSS
- Tehran Heart Center portfolio CI
Frequently asked questions about Fludrocortisone Acetate Tablets
What is Fludrocortisone Acetate Tablets?
How does Fludrocortisone Acetate Tablets work?
What is Fludrocortisone Acetate Tablets used for?
Who makes Fludrocortisone Acetate Tablets?
Is Fludrocortisone Acetate Tablets also known as anything else?
What drug class is Fludrocortisone Acetate Tablets in?
What development phase is Fludrocortisone Acetate Tablets in?
What are the side effects of Fludrocortisone Acetate Tablets?
What does Fludrocortisone Acetate Tablets target?
Related
- Drug class: All Mineralocorticoid receptor agonist drugs
- Target: All drugs targeting Mineralocorticoid receptor (MR)
- Manufacturer: Tehran Heart Center — full pipeline
- Therapeutic area: All drugs in Endocrinology / Cardiovascular
- Indication: Drugs for Acute hypotension / shock
- Indication: Drugs for Adrenocortical insufficiency
- Indication: Drugs for Salt-wasting syndromes
- Also known as: Florinef
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing