Drug intelligence / Profile preview

human normal immunoglobulin

Development stage
Approved
Lead developer
Grifols
Modality
Antibody-Based Therapeutics
Administration
Intravenous, Ophthalmic
01

Overview

Flebogamma DIF is a high-purity, pasteurized, solvent-detergent treated, and nanofiltered human normal immunoglobulin (IVIG) developed and manufactured by Grifols. Available in 5% and 10% protein concentrations, the "DIF" designation refers to the "Double Inactivation and Filtration" manufacturing process, which includes pasteurization, solvent-detergent treatment, and 20 nm nanofiltration to ensure high viral safety. The drug is primarily indicated for the treatment of primary immune thrombocytopenic purpura (ITP) in both adults and children, where it functions by blocking Fcγ-receptors on macrophages to prevent the destruction of IgG-sensitized platelets. Beyond ITP, Flebogamma DIF has been investigated for use in hospitalized COVID-19 patients and post-polio syndrome. Additionally, Grifols is collaborating with Selagine to develop an ophthalmic formulation of the drug for dry eye disease, leveraging its broad-spectrum anti-inflammatory properties to target ocular surface inflammation.

Brand names
Flebogamma DIFFlebogamma 5% DIFFlebogamma 10% DIF
Other names
human normal immunoglobulinIVIGintravenous immunoglobulin
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)DC-SIGN (Dendritic cell-specific intercellular adhesion molecule-3-grabbing non-integrin)Neuraminidase

Beyond the preview

Go deeper on human normal immunoglobulin.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on human normal immunoglobulin.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call