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Afobazol (FABOMOTIZOLE)
Afobazol (generic name: FABOMOTIZOLE) is a drug. It is currently in Phase 3 development.
Afobazol is thought to work by interacting with specific biological pathways, but the exact mechanism is unknown.
Afobazol, also known as Fabomotizole, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it has not been approved by the FDA for any indications. As a small molecule, Afobazol is likely to work by interacting with specific biological pathways, but the exact mechanism is unknown. Further research is needed to determine its efficacy and safety profile. The lack of information on its pharmacokinetics and approved indications makes it difficult to assess its clinical utility.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | FABOMOTIZOLE |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's cells are like a orchestra, and Afobazol is like a conductor that helps the cells work together in harmony. However, the specific way it conducts the orchestra is not well understood. More research is needed to figure out how Afobazol works its magic.
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders (PHASE4)
- A Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder (PHASE3)
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:
- Afobazol CI brief — competitive landscape report
- Afobazol updates RSS · CI watch RSS
Frequently asked questions about Afobazol
What is Afobazol?
How does Afobazol work?
What is the generic name of Afobazol?
What development phase is Afobazol in?
Related
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing