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Bosinji
Bosinji is a Small molecule drug developed by Kyunghee University Medical Center. It is currently in Phase 3 development. Also known as: Ucha-Shinki-Hwan.
Bosinji is being studied as a potential treatment for Cold Hypersensitivity and Lumbar Disc Herniation. It is being compared to a placebo in clinical trials, specifically in a double-blinded, randomized, multicenter study for Cold Hypersensitivity.
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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 | Bosinji |
|---|---|
| Also known as | Ucha-Shinki-Hwan |
| Sponsor | Kyunghee University Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial (PHASE2, PHASE3)
- Clinical Research on the Efficacy of Bosinji on Herniated Intervertebral Disc of Lumbar Spine (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:
- Bosinji CI brief — competitive landscape report
- Bosinji updates RSS · CI watch RSS
- Kyunghee University Medical Center portfolio CI
Frequently asked questions about Bosinji
What is Bosinji?
Who makes Bosinji?
Is Bosinji also known as anything else?
What development phase is Bosinji in?
Related
- Manufacturer: Kyunghee University Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Ucha-Shinki-Hwan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing