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Paxalisib · GDC-0084

Small molecule · Inhibitor of phosphatidylinositol 3-kinase (PI3K) · developed by Kazia Therapeutics

Phase 2/3 Most advanced trial

2 Registered trials

What is Paxalisib?

Paxalisib is an oral small-molecule inhibitor of phosphatidylinositol 3-kinase (PI3K) in the PI3K/AKT signaling pathway, which can inhibit cell growth and survival in susceptible tumor cells. It is studied in glioblastoma and diffuse midline glioma, including diffuse intrinsic pontine glioma.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: GDC-0084
Drug type: Small molecule
Targets: phosphatidylinositol 3-kinase (PI3K)
Mechanism: Inhibitor of phosphatidylinositol 3-kinase (PI3K)
Pathways: PI3K/AKT signaling
Therapy area: Oncology
Developer: Kazia Therapeutics Limited
In trials of: BHVN, JAZZ, LLY
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 2/3
UNII: P5DKZ70636

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT03970447	Phase 2/3	Glioblastoma	Recruiting	BHVN
NCT05009992	Phase 2	Diffuse Intrinsic Pontine Glioma	Recruiting	JAZZ

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Diffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-MutantGlioblastomaRecurrent Diffuse Intrinsic Pontine GliomaRecurrent Diffuse Midline Glioma, H3 K27M-MutantRecurrent WHO Grade III GliomaWHO Grade III Glioma

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z