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Fluprednylidene (FLUPREDNIDENE)

Phase 2 active Small molecule

Fluprednylidene (generic name: FLUPREDNIDENE) is a fluprednidene drug. It is currently in Phase 2 development.

Fluprednylidene works by binding to the glucocorticoid receptor, which helps to reduce inflammation and modulate the immune system.

Fluprednylidene (FLUPREDNIDENE) is a small molecule drug in the fluprednidene class, but details about its target, FDA approval status, and commercial status are currently unknown. As a glucocorticoid receptor agonist, it is believed to work by binding to the glucocorticoid receptor, which then modulates the transcription of various genes involved in inflammation and immune response. The exact indications for fluprednylidene are unclear, but it is likely used to treat conditions characterized by inflammation or immune system dysregulation. Further research is needed to fully understand its pharmacological properties and clinical applications. Its safety profile and potential side effects are also unknown at this time.

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 nameFLUPREDNIDENE
Drug classfluprednidene
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 2

Mechanism of action

Imagine your body's immune system as a fire alarm that goes off when it senses danger. Fluprednylidene helps to turn down the volume on the fire alarm, so it doesn't sound as loudly and cause unnecessary inflammation. This can help to reduce swelling, pain, and other symptoms associated with conditions like arthritis or asthma.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Fluprednylidene

What is Fluprednylidene?

Fluprednylidene (FLUPREDNIDENE) is a fluprednidene drug.

How does Fluprednylidene work?

Fluprednylidene works by binding to the glucocorticoid receptor, which helps to reduce inflammation and modulate the immune system.

What is the generic name of Fluprednylidene?

FLUPREDNIDENE is the generic (nonproprietary) name of Fluprednylidene.

What drug class is Fluprednylidene in?

Fluprednylidene belongs to the fluprednidene class. See all fluprednidene drugs at /class/fluprednidene.

What development phase is Fluprednylidene in?

Fluprednylidene is in Phase 2.

Related

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