Drug Profile

Paxalisib - Kazia Therapeutics

Alternative Names: G-02441729; GDC-0084; RG 7666; SIM-0395; SVG-103

Latest Information Update: 03 Feb 2026

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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

27 Jan 2026 Efficacy and adverse events data from a phase Ib trial in Triple negative breast cancer released by Kazia Therapeutics
22 Dec 2025 SoVarGen plans a phase Ib/IIa trial for Focal cortical dysplasia, Tuberous sclerosis and Craniofacial-abnormalities (PO), in March 2026 (NCT07287202)
10 Dec 2025 Efficacy and adverse event data from the phase Ib ABC-Pax trial in Triple-negative-breast-cancer released by Kazia Therapeutics

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