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Biligen (FENCIBUTIROL)
Biligen (generic name: FENCIBUTIROL) is a drug. It is currently in Phase 2 development.
Biligen works by binding to a specific target, altering its function to produce a therapeutic effect.
Biligen, also known as FENCIBUTIROL, is a small molecule modality developed by an unknown entity. Its current owner is also unknown. The target and drug class of Biligen are not specified. It is not known if Biligen is FDA approved or has any approved indications. The commercial status of Biligen, including whether it is patented or generic, is also unknown.
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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 | FENCIBUTIROL |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells have locks on them, and Biligen is a key that fits into those locks. When Biligen binds to its target, it helps to unlock the cell's function, allowing it to work properly and treat a specific condition. This is a simplified explanation of how Biligen works at a cellular level.
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Biligen CI brief — competitive landscape report
- Biligen updates RSS · CI watch RSS
Frequently asked questions about Biligen
What is Biligen?
How does Biligen work?
What is the generic name of Biligen?
What development phase is Biligen in?
Related
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing