Last reviewed · How we verify
Gelofusine 4%
Gelofusine 4% is a Plasma volume expander; colloid Small molecule drug developed by B. Braun Melsungen AG. It is currently in Phase 3 development for Acute hypovolemia and restoration of circulating blood volume in surgery and trauma, Perioperative fluid replacement. Also known as: Colloid.
Gelofusine 4% is a plasma volume expander that increases and maintains circulating blood volume by providing a colloidal solution that draws and retains fluid in the intravascular space.
Gelofusine 4% is a plasma volume expander that increases and maintains circulating blood volume by providing a colloidal solution that draws and retains fluid in the intravascular space. Used for Acute hypovolemia and restoration of circulating blood volume in surgery and trauma, Perioperative fluid replacement.
-
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 | Gelofusine 4% |
|---|---|
| Also known as | Colloid |
| Sponsor | B. Braun Melsungen AG |
| Drug class | Plasma volume expander; colloid |
| Modality | Small molecule |
| Therapeutic area | Critical Care; Perioperative Medicine |
| Phase | Phase 3 |
Mechanism of action
Gelofusine is a modified fluid gelatin (succinylated gelatin) that functions as a colloid, meaning its large molecular weight particles remain in the bloodstream longer than crystalloid solutions. It restores intravascular volume and improves tissue perfusion in hypovolemic states by osmotic pressure, helping to maintain hemodynamic stability during surgery, trauma, or critical illness.
Approved indications
- Acute hypovolemia and restoration of circulating blood volume in surgery and trauma
- Perioperative fluid replacement
Common side effects
- Allergic reactions (urticaria, anaphylaxis)
- Coagulopathy / bleeding
- Acute kidney injury
- Hyperamylasemia
Key clinical trials
- Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers (PHASE1)
- Gelaspan vs Crystalloid Therapy in Sepsis (PHASE4)
- Low-dose Naltrexone for Post-COVID Fatigue Syndrome (PHASE2)
- The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals (NA)
- Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder (PHASE2)
- Evaluation of the Effectiveness of Different Procedures on Palatinal Wound Healing After Free Gingival Graft Surgery. (NA)
- Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought (PHASE1, PHASE2)
- Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties (NA)
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:
- Gelofusine 4% CI brief — competitive landscape report
- Gelofusine 4% updates RSS · CI watch RSS
- B. Braun Melsungen AG portfolio CI
Frequently asked questions about Gelofusine 4%
What is Gelofusine 4%?
How does Gelofusine 4% work?
What is Gelofusine 4% used for?
Who makes Gelofusine 4%?
Is Gelofusine 4% also known as anything else?
What drug class is Gelofusine 4% in?
What development phase is Gelofusine 4% in?
What are the side effects of Gelofusine 4%?
Related
- Drug class: All Plasma volume expander; colloid drugs
- Manufacturer: B. Braun Melsungen AG — full pipeline
- Therapeutic area: All drugs in Critical Care; Perioperative Medicine
- Indication: Drugs for Acute hypovolemia and restoration of circulating blood volume in surgery and trauma
- Indication: Drugs for Perioperative fluid replacement
- Also known as: Colloid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing