Atuzabrutinib is under clinical development by Principia Biopharma 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 Atuzabrutinib’s likelihood of approval (LoA) and phase transition for Hepatic Injury took place on 18 Dec 2020, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 18 Dec 2020 decreased Atuzabrutinib’s LoA and PTSR for Pemphigus Foliaceus.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Atuzabrutinib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Atuzabrutinib overview

Atuzabrutinib (PRN-473) is under development for the treatment of hepatic injury, mild to moderate atopic dermatitis, allergies, pemphigus foliaceus and unspecified dermatological disorders. It is a small molecule, administered topically. It acts as a protein kinase BTK inhibitor. The drug candidate is based on Tailored covalency technology platform. It was under development for the treatment of rheumatoid arthritis.

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.

Quick View Atuzabrutinib LOA Data

Report Segments
  • Innovator
Drug Name
  • Atuzabrutinib
Administration Pathway
  • Topical
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Immunology
Key Developers
Highest Development Stage
  • Phase II

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.