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UMC119-06-05
UMC119-06-05 is a Biologic drug developed by Meridigen Biotech Co., Ltd.. It is currently in Phase 1 development.
UMC119-06-05 is a treatment being studied for frailty syndrome, among other conditions, in a Phase I clinical trial. The treatment involves intravenous infusion of UMC119-06-05, which is a type of mesenchymal stem cell.
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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 | UMC119-06-05 |
|---|---|
| Sponsor | Meridigen Biotech Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Mesenchymal Stem Cells for Frailty Syndrome (PHASE1, PHASE2)
- Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells (PHASE2)
- Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA). (PHASE1)
- Mesenchymal Stem Cells for The Treatment of Frailty Syndrome (PHASE1)
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:
- UMC119-06-05 CI brief — competitive landscape report
- UMC119-06-05 updates RSS · CI watch RSS
- Meridigen Biotech Co., Ltd. portfolio CI
Frequently asked questions about UMC119-06-05
What is UMC119-06-05?
Who makes UMC119-06-05?
What development phase is UMC119-06-05 in?
Related
- Manufacturer: Meridigen Biotech Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing