Immune globulin (human) is under clinical development by GC Biopharma and currently in the Phase II and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Immune globulin (human)’s likelihood of approval (LoA) and phase transition for Autoimmune Encephalitis (Post-Infectious) took place on 03 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Immune globulin (human) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Immune globulin (human) overview

Human normal immunoglobulin (Globulin SN) contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It is formulated as solution for intravenous route of administration. It is indicated for the treatment of primary immunodeficiency syndromes such as congenital agammaglobulinaemia and hypogammaglobulinaemia, severe combined immunodeficiencies, Wiskott Aldrich syndrome, chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections and children with congenital AIDS who have repeated bacterial infections. Globucel is used as immunomodulator in Idiopathic thrombocytopenic purpura (ITP), Guillain Barre Syndrome and Kawasaki disease.

It is under development for primary humoral immunodeficiency, primary immune deficiency, congenital immunodeficiency, immune thrombocytopenia, autoimmune encephalitis.

It was also under development for primary immune deficiency.

GC Biopharma overview

GC Biopharma, formerly known as GC Pharma, a subsidiary of Green Cross Holdings Corp, provides plasma protein therapeutics and vaccines. The company develops, manufactures, and markets a wide product portfolio comprising plasma derivatives including albumin, immunoglobulin, and antithrombin; vaccines for infectious diseases; prescription drugs for treating cardiovascular, respiratory, central nervous system (CNS), gastrointestinal and immunology diseases, musculoskeletal disorders, genetic disorders, metabolic disorders and hematological disorders; and Over-the-counter (OTC) drugs including anti-inflammatory drugs, anti-allergic products, and others. The company focuses its research and development activities on developing drugs for treatment of cancer, tuberculosis, and hunter syndrome, among others. GC Biopharma is headquartered Yongin, Gyeonggi-do, South Korea.

Quick View Immune globulin (human) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Immune globulin (human)
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.