Paxalisib is under clinical development by Kazia Therapeutics and currently in the Phase I, Phase II and Phase III 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 Paxalisib’s likelihood of approval (LoA) and phase transition for Glioblastoma Multiforme (GBM) took place on 16 Feb 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 16 Feb 2022 increased Paxalisib’s Phase Transition Success Rate (PTSR) for Metastatic Brain Tumor.

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

Paxalisib overview

Paxalisib is under development for the treatment of high-grade glioblastoma or glioma, breast cancer metastases to brain, pediatric diffuse intrinsic pontine glioma, solid tumors with brain metastases and leptomeningeal metastases, primary CNS lymphoma and anaplastic astrocytoma, rhabdoid/teratoid tumors (AT/RT) and metastatic melanoma. It is a small molecule administered orally as a capsule. It acts by targeting the phosphoinositide 3-kinase and mTOR. The drug candidate was under development for the treatment of patients recurrent high-grade glioblastoma or glioma.

Kazia Therapeutics overview

Kazia Therapeutics (Kazia) is a clinical stage biotechnology company which focuses on the discovery and development of anti-cancer drugs. The company’s product pipeline includes paxalisib (formerly GDC-0084) and Cantrixil (TRX-E-002-1). Paxalisib is an inhibitor of PI3K /AKT /mTOR pathway to treat glioblastoma multiforme It is in phase II clinical trials. TRX-E-002-1 (Cantrixil) is a third generation benzopyran molecule that acts against cancer stem cells. Cantrixil is in phase I clinical trials for the treatment of ovarian cancer. The company has collaborations with various research institutes, hospitals, and universities including St Jude Children’s Hospital, University of Newcastle, Dana Farber Cancer Institute and Memorial Sloan Kettering Cancer Centre to develop its pipeline. Kazia is headquartered in Sydney, New South Wales, Australia.

Quick View Paxalisib LOA Data

Report Segments
  • Innovator
Drug Name
  • Paxalisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.