Kcentra is under clinical development by CSL and currently in Phase III for Trauma. According to GlobalData, Phase III drugs for Trauma does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kcentra LoA Report. 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.

Kcentra overview

Blood coagulation factors II, VII, IX, X, protein C, protein S (Beriplex P/N, Beriplex AU) is a fixed dose combination product, acts as an antihemorrhagic agent. It is formulated as injection lyophilized powder for solution for intravenous route of administration. It is indicated for treatment and perioperative prophylaxis of bleeding in acquired of clotting factor prothrombin complex, such as deficiency caused by treatment with Vitamin K Antagonist, or if antagonist overdose of vitamin K deficiency, when necessary rapid correction of the deficiency thereof, treatment and perioperative prophylaxis in cases of bleeding in congenital deficiency of any of the factors dependent coagulation vitamin K, when not available purified products of the specific factor. It is under development for the treatment of trauma  It was also under development for the treatment of unspecified indications.

It is under development for the treatment of massive haemorrhage associated with severe traumatic injury.

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, respiratory disease, neurological disorders 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 Kcentra’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.