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Hexobutyramide (BUTOCTAMIDE)
Hexobutyramide (generic name: BUTOCTAMIDE) is a drug. It is currently in Phase 2 development.
Hexobutyramide works by binding to and modulating the activity of specific biological molecules to produce a therapeutic effect.
Hexobutyramide is a small molecule. It is also known by the synonyms butoctamide and butoctamida.
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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 | BUTOCTAMIDE |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like a orchestra, and each cell has its own specific role to play. Hexobutyramide is like a conductor that helps the cells work together in harmony by binding to and modulating the activity of specific molecules. This helps to restore balance and normal function to the cells and tissues.
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:
- Hexobutyramide CI brief — competitive landscape report
- Hexobutyramide updates RSS · CI watch RSS
Frequently asked questions about Hexobutyramide
What is Hexobutyramide?
How does Hexobutyramide work?
What is the generic name of Hexobutyramide?
What development phase is Hexobutyramide in?
Related
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing