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Difluocortolone (DIFLUCORTOLONE)
Difluocortolone (generic name: DIFLUCORTOLONE) is a diflucortolone drug. It is currently in Phase 2 development.
Difluocortolone works by mimicking the effects of cortisol in the body to reduce inflammation and suppress the immune system.
Difluocortolone is a small molecule corticosteroid drug of the diflucortolone class. Its exact target and mechanism of action are unknown, but it is believed to work by mimicking the effects of cortisol in the body, reducing inflammation and suppressing the immune system. Difluocortolone is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. As a result, there is limited information available on its safety profile and potential side effects. Further research is needed to fully understand the properties and potential uses of difluocortolone.
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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.
| 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 name | DIFLUCORTOLONE |
|---|---|
| Drug class | diflucortolone |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's immune system as a fire alarm that sounds when it detects something wrong. Cortisol is like a fire chief that comes to put out the fire, but also makes sure the alarm doesn't go off unnecessarily. Difluocortolone is like a fake fire chief that does the same job, but in a controlled way to help with inflammation and immune system issues.
Approved indications
Common side effects
Key clinical trials
- A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis
- An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids
- Hepatocellular Carcinoma - Advanced Stage - Sorafenib Trial in Taiwanese Patients (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:
- Difluocortolone CI brief — competitive landscape report
- Difluocortolone updates RSS · CI watch RSS
Frequently asked questions about Difluocortolone
What is Difluocortolone?
How does Difluocortolone work?
What is the generic name of Difluocortolone?
What drug class is Difluocortolone in?
What development phase is Difluocortolone in?
Related
- Drug class: All diflucortolone drugs
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing