Alpha-1 proteinase inhibitor (human) is under clinical development by Grifols and currently in Phase III for Emphysema. According to GlobalData, Phase III drugs for Emphysema have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Alpha-1 proteinase inhibitor (human)’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Alpha-1 proteinase inhibitor (human) overview

Alpha1-proteinase inhibitor human (Prolastin, Trypsone, Pulmolast, Lynspad) also known as alpha1-antitrypsin, belonging to the serpin superfamily prepared from human plasma via Cohn alcohol fractionation followed by PEG and zinc chloride fractionation. It is formulated as powder for solution for intravenous route of administration. Alpha1-proteinase inhibitor injection is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha1-PI (alpha1-antitrypsin deficiency), related to genotypes PiZZ, PiZ(null), Pi (null)(null), PiSZ or other deficiency causing alleles, and with clinically demonstrable emphysema. Alpha1-proteinase inhibitor is also under development for the treatment of coronavirus disease 2019 (covid-19) associated acute respiratory distress syndrome, cystic fibrosis, pulmonary emphysema due to alpha1-antitrypsin deficiency. It was under development for the treatment of type 1 diabetes, coronavirus disease 2019 (COVID-19) and chronic fatigue syndrome. It is administered through inhalational and subcutaneous route.

Grifols overview

Grifols is a pharmaceutical and chemical manufacturing company engaged on enhancing the health and well-being of patients worldwide. It is focused on research, development, manufacturing and marketing of plasma-derived therapies, hospital pharmacy products and diagnostic technology for clinical use. The company produces plasma derived protein therapies for patients suffering with rare, chronic and life-threatening infections. Grifols offers biological materials for clinical trials, biotechnology research, manufacturing pharmaceutical and diagnostic products. Grifols provides transfusion medicine, hemostasis and immunoassay solutions for blood banks, clinical laboratories and transfusion centers. The company offers its products to hospitals, pharmacies and healthcare professionals. It offers products in the US, Canada, Europe, and Rest of the world. Grifols is headquartered in Barcelona, Spain.

For a complete picture of Alpha-1 proteinase inhibitor (human)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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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.