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Pentaglobin
Pentaglobin is a Small molecule drug developed by Medical University of Vienna. It is currently in Phase 2 development. Also known as: IgGAM.
Pentaglobin is an IgM-enriched intravenous immunoglobulin used in the treatment of neonatal sepsis, as per a Phase 4 study. It has also been studied in various other conditions, including COVID-19, polyneuropathies, shock, and septic conditions, according to ClinicalTrials.gov.
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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).
| 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 | Pentaglobin |
|---|---|
| Also known as | IgGAM |
| Sponsor | Medical University of Vienna |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (PHASE2)
- Pentaglobin in CRE and PA Neutropenic Infections (PHASE2)
- Role of Immunoglobulin in Male Infertility (NA)
- Efficacy and Safety of Therapy With IgM-enriched Immunoglobulin With a Personalized Dose vs Standard Dose in Patients With Septic Shock. (PHASE3)
- Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) (PHASE2, PHASE3)
- PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring
- Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates (PHASE4)
- IgM-Enriched Immunoglobulin for Neonatal Sepsis (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:
- Pentaglobin CI brief — competitive landscape report
- Pentaglobin updates RSS · CI watch RSS
- Medical University of Vienna portfolio CI
Frequently asked questions about Pentaglobin
What is Pentaglobin?
Who makes Pentaglobin?
Is Pentaglobin also known as anything else?
What development phase is Pentaglobin in?
Related
- Manufacturer: Medical University of Vienna — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: IgGAM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing