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Plasbumin®-20
Plasbumin®-20 is a Plasma volume expander; Colloid solution Small molecule drug developed by Healthgen Biotechnology Corp.. It is currently in Phase 3 development for Hypovolemia and shock management, Plasma volume restoration in critical care settings, Albumin replacement in hypoalbuminemia.
Plasbumin-20 is a human serum albumin solution that acts as a plasma volume expander and colloid to restore intravascular oncotic pressure and improve tissue perfusion.
Plasbumin-20 is a human serum albumin solution that acts as a plasma volume expander and colloid to restore intravascular oncotic pressure and improve tissue perfusion. Used for Hypovolemia and shock management, Plasma volume restoration in critical care settings, Albumin replacement in hypoalbuminemia.
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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 | Plasbumin®-20 |
|---|---|
| Sponsor | Healthgen Biotechnology Corp. |
| Drug class | Plasma volume expander; Colloid solution |
| Target | Plasma oncotic pressure regulation |
| Modality | Small molecule |
| Therapeutic area | Critical Care; Hematology |
| Phase | Phase 3 |
Mechanism of action
Human serum albumin (HSA) is a naturally occurring protein that maintains plasma oncotic pressure and serves as a carrier for various endogenous and exogenous substances. Plasbumin-20 is a 20% concentration albumin solution administered intravenously to restore blood volume and improve hemodynamic stability in hypovolemic states. It helps maintain adequate tissue perfusion and oxygen delivery by expanding the intravascular compartment.
Approved indications
- Hypovolemia and shock management
- Plasma volume restoration in critical care settings
- Albumin replacement in hypoalbuminemia
Common side effects
- Hypervolemia
- Pulmonary edema
- Allergic reactions
- Fever
- Chills
Key clinical trials
- Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells (PHASE2)
- Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (PHASE3)
- A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites (PHASE3)
- Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass (PHASE4)
- Albumin Replacement Therapy in Septic Shock (PHASE3)
- Phase II/III of Recombinant Human Albumin Injection (PHASE2)
- A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia (PHASE3)
- Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours. (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:
- Plasbumin®-20 CI brief — competitive landscape report
- Plasbumin®-20 updates RSS · CI watch RSS
- Healthgen Biotechnology Corp. portfolio CI
Frequently asked questions about Plasbumin®-20
What is Plasbumin®-20?
How does Plasbumin®-20 work?
What is Plasbumin®-20 used for?
Who makes Plasbumin®-20?
What drug class is Plasbumin®-20 in?
What development phase is Plasbumin®-20 in?
What are the side effects of Plasbumin®-20?
What does Plasbumin®-20 target?
Related
- Drug class: All Plasma volume expander; Colloid solution drugs
- Target: All drugs targeting Plasma oncotic pressure regulation
- Manufacturer: Healthgen Biotechnology Corp. — full pipeline
- Therapeutic area: All drugs in Critical Care; Hematology
- Indication: Drugs for Hypovolemia and shock management
- Indication: Drugs for Plasma volume restoration in critical care settings
- Indication: Drugs for Albumin replacement in hypoalbuminemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing