Paxalisib is a Small Molecule owned by Kazia Therapeutics, and is involved in 11 clinical trials, of which 2 were completed, and 9 are ongoing.

Paxalisibacts as dual PI3K alpha and mTOR inhibitor. The PI3K/mTOR pathway plays a key role in promoting cancer cell proliferation. PI3K activation signals AKT, which activates mTOR, a serine-threonine kinase downstream of PI3K. The therapeutic candidate elicits anti neoplastic activity by inhibiting and suppressing the signaling within this pathway that causes tumor growth.

The revenue for Paxalisib is expected to reach a total of $811m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Paxalisib NPV Report.

Paxalisib was originated by Genentech USA and is currently owned by Kazia Therapeutics.

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.

The operating loss of the company was AUD25 million in FY2022, compared to an operating loss of AUD8.9 million in FY2021. The net loss of the company was AUD24.7 million in FY2022, compared to a net loss of AUD8.4 million in FY2021.

Quick View – Paxalisib

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

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.