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Biosone (ENOXOLONE)
Biosone (generic name: ENOXOLONE) is a enoxolone drug. It is currently in Phase 2 development.
Biosone works by blocking the enzyme that converts cortisol into cortisone, reducing inflammation.
Biosone (ENOXOLONE) is a small molecule enoxolone that targets corticosteroid 11-beta-dehydrogenase isozyme 2. It is not FDA-approved, and its commercial status is unknown. Biosone works by inhibiting the enzyme responsible for converting cortisol into cortisone, thereby reducing inflammation. It is being developed for potential use in treating various inflammatory conditions, but its exact indications and safety profile are not well established. Further research is needed to determine its efficacy and safety in humans.
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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).
| 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 | ENOXOLONE |
|---|---|
| Drug class | enoxolone |
| Target | High mobility group protein B1, Aldo-keto reductase family 1 member B10, Cocaine esterase |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 2 |
Mechanism of action
Think of cortisol as a fire that can get out of control and cause damage. Cortisol is converted into cortisone, which is a less active form, by an enzyme called 11-beta-dehydrogenase. Biosone blocks this enzyme, so cortisol stays active and can't cause as much inflammation.
Approved indications
Common side effects
Key clinical trials
- Glycyrrhetinic Acid and Acute Irritant Dermatitis (NA)
- Enoxolone in Major Depression - Biomarker-outcome Relationship (PHASE1,PHASE2)
- The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia (PHASE2)
- Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery (NA)
- To Evaluate Maximally Tolerated Dose (MTD), Safety and Efficacy of CPI-613® (Devimistat) Plus Hydroxychloroquine in Patients With Relapsed or Refractory Clear Cell Sarcoma of Soft Tissue (PHASE1,PHASE2)
- Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II (PHASE2)
- The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia (PHASE2)
- Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP (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:
- Biosone CI brief — competitive landscape report
- Biosone updates RSS · CI watch RSS
Frequently asked questions about Biosone
What is Biosone?
How does Biosone work?
What is the generic name of Biosone?
What drug class is Biosone in?
What development phase is Biosone in?
What does Biosone target?
Related
- Drug class: All enoxolone drugs
- Target: All drugs targeting High mobility group protein B1, Aldo-keto reductase family 1 member B10, Cocaine esterase
- Therapeutic area: All drugs in Nephrology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing