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Flucortolone (FLUOCORTOLONE)

Phase 2 active Small molecule

Flucortolone (generic name: FLUOCORTOLONE) is a fluocortolone drug. It is currently in Phase 2 development.

Flucortolone works by binding to glucocorticoid receptors in the body, which helps to reduce inflammation and suppress the immune system.

Flucortolone is a small molecule corticosteroid drug of the fluocortolone class. Its mechanism of action involves binding to glucocorticoid receptors, leading to anti-inflammatory and immunosuppressive effects. However, due to limited information, its target and approved indications are unknown. The commercial status of flucortolone is also unclear, with no information available on its patent status or generic manufacturers. Further research is needed to fully understand its clinical applications and safety profile.

Likelihood of approval
16.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameFLUOCORTOLONE
Drug classfluocortolone
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Imagine your body's immune system as a fire alarm that sounds when it detects something foreign. Flucortolone helps to turn down the volume on the fire alarm, reducing the inflammation and immune response that can cause harm. This allows the body to heal and recover from injuries or infections.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Flucortolone

What is Flucortolone?

Flucortolone (FLUOCORTOLONE) is a fluocortolone drug.

How does Flucortolone work?

Flucortolone works by binding to glucocorticoid receptors in the body, which helps to reduce inflammation and suppress the immune system.

What is the generic name of Flucortolone?

FLUOCORTOLONE is the generic (nonproprietary) name of Flucortolone.

What drug class is Flucortolone in?

Flucortolone belongs to the fluocortolone class. See all fluocortolone drugs at /class/fluocortolone.

What development phase is Flucortolone in?

Flucortolone is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing