Drug Profile

Paxalisib - Kazia Therapeutics

Alternative Names: G-02441729; GDC-0084; RG 7666; SIM-0395

Latest Information Update: 06 Feb 2025

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At a glance

Originator Genentech
Developer Alliance for Clinical Trials in Oncology; Dana-Farber Cancer Institute; Genentech; Global Coalition for Adaptive Research; Huntsman Cancer Institute; John Hopkins University; Kazia Therapeutics; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); St. Jude Childrens Research Hospital; University of California; Weill Cornell Medical College
Class Amines; Antineoplastics; Morpholines; Oxazines; Purines; Pyrimidines; Small molecules
Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; MTOR protein inhibitors; Proto-oncogene protein c-akt inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Rhabdoid tumour; Diffuse intrinsic pontine glioma; Glioblastoma
New Molecular Entity Yes

Phase II/III Glioblastoma
Phase II Brain metastases; Glioma; Lymphoma
Phase I/II Cancer
Phase I Triple negative breast cancer
Preclinical Malignant melanoma; Rhabdoid tumour
No development reported Diffuse intrinsic pontine glioma; Meningeal carcinomatosis

30 Jan 2025 Phase-I clinical trials in Triple negative breast cancer(Second-line or greater therapy; Late-stage disease) in Australia (unspecified route)
14 Jan 2025 Kazia Therapeutics completes a Phase-II/III GBM AGILE in Glioblastoma in USA, Australia, Canada, France, Germany, Switzerland, Austria and Italy (PO) before January 2025 (NCT03970447)
31 Dec 2024 Kazia Therapeutics completes a Type C meeting with the US FDA to discuss the potential pathways to registration of paxalisib in Glioblastoma multiforme

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