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Buagafuran
Buagafuran is a Small molecule drug developed by Beijing Union Pharmaceutical Factory Ltd. It is currently in Phase 1 development. Also known as: AF-5.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Buagafuran |
|---|---|
| Also known as | AF-5 |
| Sponsor | Beijing Union Pharmaceutical Factory Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetic Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function (PHASE1)
- Study on the Drug Interaction Between Buagafuran and Voriconazole (PHASE1)
- Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD (PHASE3)
- Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD (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:
- Buagafuran CI brief — competitive landscape report
- Buagafuran updates RSS · CI watch RSS
- Beijing Union Pharmaceutical Factory Ltd portfolio CI
Frequently asked questions about Buagafuran
What is Buagafuran?
Who makes Buagafuran?
Is Buagafuran also known as anything else?
What development phase is Buagafuran in?
Related
- Manufacturer: Beijing Union Pharmaceutical Factory Ltd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: AF-5
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing