Octanorm is under clinical development by Octapharma and currently in the Phase III 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 Octanorm’s likelihood of approval (LoA) and phase transition for Primary Immune Deficiency (PID) took place on 03 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Octanorm overview

Immunoglobulin G (Human) (Octonorm) contains mainly normal human immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It is formulated as injectable solution for subcutaneous and intramuscular route of administration. It is formulated as injectable solution for intravenous or intramuscular or subcutaneous route of administration. Human normal immunoglobulin is used 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.

Immune globulin (Newnorm) is under development for treatment of primary immune deficiency disorders (PID). The drug candidate is administered subcutaneously. It was under development for the treatment of dermatomyositis.

Octapharma overview

Octapharma is a human protein product manufacturer that focuses on developing and producing medicines through human proteins from human plasma and cell lines. The company treats patients worldwide with products across immunotherapy, hematology and critical care therapeutic areas. It sources plasma from company-owned plasma donation centers and other external sources. Octapharma owns plasma donation centers in the US and Germany and owns production facilities in Austria, Germany, France, Mexico and Sweden. The company’s production plants carry out plasma fractionation and purification, pharmaceutical production, research and development, product labeling, packaging, storage and distribution. Octapharma is headquartered in Lachen, Switzerland.

Quick View Octanorm LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Octanorm
Administration Pathway
  • Intramuscular
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Hematological Disorders
  • Immunology
  • Musculoskeletal Disorders
  • Oncology
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.