Garadacimab is under clinical development by CSL and currently in Pre-Registration for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency). According to GlobalData, Pre-Registration drugs for Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency) have an 86% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Garadacimab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Garadacimab overview
Garadacimab (CSL-312) is under development for the treatment of hereditary angioedema (HAE), idiopathic pulmonary fibrosis (IPF) and interstitial lung diseases (ILD). It is administered through subcutaneous and intravenous routes The drug candidate is a recombinant fully human monoclonal antibody. It is a variant of 3F7 with improved affinity and potency. The drug candidate acts by antagonizing FXIIa. It was also under development for contact-activated thrombosis, acute respiratory distress syndrome (ARDS), coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and pneumonia.
CSL overview
CSL discovers, develops, manufactures, commercializes and distributes biopharmaceuticals and related products. Its portfolio encompasses plasma-derived products for the treatment of hemophilia, hereditary angioedema, von Willebrand disease, inherited primary and secondary immune deficiencies, neurological disorders, respiratory disease, and protein-based medicines for treating serious human illnesses. The company also provides products for the prevention of hemolytic disease in newborns, infection in solid organ transplant recipients and to treat specific infections for victims of trauma and burns. CSL markets an array of vaccines, anti-venoms and pharmaceutical products of various other manufacturers. The company sells its products in Australia, Germany, Switzerland, the US, the UK and other countries. CSL is headquartered in Parkville, Victoria, Australia.
For a complete picture of Garadacimab’s drug-specific PTSR and LoA scores, buy the report here.
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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
