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pneumostem
pneumostem is a Small molecule drug developed by Samsung Medical Center. It is currently in Phase 2 development. Also known as: Cell therapy product, Human umbilical cord blood-derived mesenchymal stem cells, Umbilical cord blood derived mesenchymal stem cells, human umbilical cord blood-derived mesenchymal stem cells.
Pneumostem is a treatment being studied for various conditions, including Bronchopulmonary Dysplasia, Respiratory Tract Infections, and Premature Birth of Newborn, among others. It is being compared to Normal Saline in clinical trials, specifically in a Phase II trial for the treatment of Bronchopulmonary Dysplasia in premature infants.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | pneumostem |
|---|---|
| Also known as | Cell therapy product, Human umbilical cord blood-derived mesenchymal stem cells, Umbilical cord blood derived mesenchymal stem cells, human umbilical cord blood-derived mesenchymal stem cells |
| Sponsor | Samsung Medical Center |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension (PHASE1)
- Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a) (PHASE2)
- Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial (PHASE2)
- PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants (PHASE2)
- Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial (NA)
- Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants (PHASE2)
- Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
- Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
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:
- pneumostem CI brief — competitive landscape report
- pneumostem updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about pneumostem
What is pneumostem?
Who makes pneumostem?
Is pneumostem also known as anything else?
What development phase is pneumostem in?
Related
- Manufacturer: Samsung Medical Center — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: Cell therapy product, Human umbilical cord blood-derived mesenchymal stem cells, Umbilical cord blood derived mesenchymal stem cells, human umbilical cord blood-derived mesenchymal stem cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing