C1 esterase inhibitor (human) is under clinical development by Takeda Pharmaceutical and currently in the Phase I and Phase II 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 C1 esterase inhibitor (human)’s likelihood of approval (LoA) and phase transition for Acquired (Autoimmune) Hemolytic Anemia took place on 17 Jun 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 C1 esterase inhibitor (human) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

C1 esterase inhibitor (human) overview

C1 esterase inhibitor (Cinryze, SHP616) is a sterile, lyophilized preparation derived from human plasma. Cinryze is formulated in the form of injection for intravenous route of administration. Cinryze is indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). It is also used for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE.

It is under development for the treatment of traumatic brain injury, aneurysmal subarachnoid hemorrhage and autoimmune hemolytic anemia (AIHA). It was under development for the treatment of acute antibody-mediated rejection in recipients of donor-sensitized kidney transplants, paroxysmal nocturnal hemoglobinuria, hereditary angioedema (EU) and neuromyelitis optica.

Takeda Pharmaceutical overview

Takeda Pharmaceutical (Takeda) is a research-based pharmaceutical company which focuses on the discovery, development, manufacturing, marketing, commercialization, import and export of pharmaceutical drugs. The company offers products in the areas of rare diseases, gastrointestinal, oncology, neuroscience, vaccines, and plasma-derived therapies. Takeda has facilities in Japan, Argentina, Brazil, Mexico, the US, Denmark, Norway, Europe, Poland, Russia, Spain, Switzerland, China and India, Canada among others. It markets products directly and through a network of wholesale distributors, retail chains and other purchasing groups worldwide. Takeda has partnership with academic institutions, small biotech, and large pharmaceutical companies. It has presence in the Americas, Europe, and Asia, among others. Takeda is headquartered in Tokyo, Japan.

Quick View C1 esterase inhibitor (human) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • C1 esterase inhibitor (human)
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • 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.