Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
GBS hyperimmune IVIG is a specialized intravenously administered immune globulin (IVIG) product developed by immunizing plasma donors to achieve high levels of Group B Streptococcus (GBS) type-specific antibodies. This hyperimmune formulation exhibits significantly greater GBS type-specific opsonic activity compared to standard IVIG, demonstrating a >90% activity at a 1:1280 dilution versus 1:10 for standard IVIG. Preclinical studies in suckling rats showed 100% survival after GBS type-specific infection when treated with GBS hyperimmune IVIG, compared to less than or equal to 20% with standard IVIG. Clinical evaluation in neonates with suspected sepsis indicated that GBS hyperimmune IVIG, particularly at a 500 mg/kg dose, produced a sustained fourfold increase in serum GBS type-specific IgG for over six weeks, along with a correlated rise in opsonic activity, without observed adverse effects. The product aims to provide passive immunity against GBS infections, particularly in vulnerable populations like neonates.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on GBS hyperimmune IVIG.