Rilzabrutinib is under clinical development by Principia Biopharma and currently in Phase III for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura). According to GlobalData, Phase III drugs for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Rilzabrutinib’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.

Rilzabrutinib overview

Rilzabrutinib (PRN-1008) is under development for the treatment of autoimmune hemolytic anemia, immune thrombocytopenic purpura, asthma, Chronic spontaneous urticaria, atopic dermatitis and IgG4-related disease. The drug candidate is a small molecule administered orally. The drug candidate targets Bruton's tyrosine kinase (BTK) enzyme. It is based on Tailored covalency technology platform. It was also under development for rheumatoid arthritis, systemic lupus erythematosus (SLE) and inflammatory bowel disease.

Rilzabrutinib was under development for the treatment of pemphigus foliaceus, newly diagnosed or relapsing pemphigus vulgaris,

Principia Biopharma overview

Principia Biopharma is a clinical stage biopharmaceutical company. It designs and develops oral small molecule drug therapies for immune disorders and cancer. The company, through its proprietary Tailored Covalency platform, develops a portfolio of drug candidates such as rilzabrutinib, PRN473 Topical, PRN2246 and immunoproteasome inhibitor. Its rilzabrutinib drug candidated, is used for the treatment of pemphigus vulgaris, immune thrombocytopenia and IgG4-related diseases, is a reversible covalent BTK inhibitor. PRN2246, which crosses the blood-brain barrier, is under Phase 1 clinical trial as an oral therapy to treat autoimmunity and neuro-inflammatory diseases. The PRN2246 candidate, under Phase 1 trial, is used in treating MS and central nervous system diseases and immunoproteasome inhibitor for treatment of inflammation and autoimmune disorders. Principia Biopharma is headquartered in South San Francisco, California, the US.

For a complete picture of Rilzabrutinib’s drug-specific PTSR and LoA scores, buy the report here.


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.