Paxalisib

Phase 2Small molecule

KKazia Therapeutics Limited

Paxalisib is one of 108 small molecule programs targeting Glioma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

107

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

Diffuse Intrinsic Pontine GliomaRecruiting

GlioblastomaActive, not recruiting

Atypical Teratoid/rhabdoid TumorRecruiting

GliomaPhase 2

Active, not recruiting

Diffuse Intrinsic Pontine GliomaPhase 2

Recruiting

GlioblastomaPhase 2/Phase 3

Active, not recruiting

Atypical Teratoid/rhabdoid TumorPhase 2

Recruiting

Competition

Competitive Landscape

514 competitors in Glioblastoma

#DrugCompanyPhaseTrials

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

161 2

Ceenu

AAzurity Pharmaceuticals

Phase 3

22 3

Gleevec

Novartis

Phase 3

2 4

Cymbalta

Alnylam Pharmaceuticals

Phase 3

1 5

Scemblix

Novartis

Phase 3

1 6

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

4 7

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

4 8

Feraheme

AAzurity Pharmaceuticals

Phase 3

4 9

Droxia

TTheravia

Phase 3

3 10

Paraplatin

AAvyxa

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Recurrent or Refractory

NCT04906096

Q2 2029

Phase 1/2Recruiting

Tumour

NCT07391215

Phase 2Recruiting

Diffuse Intrinsic Pontine Glioma

NCT05009992

Q2 2030

PreclinicalRecruiting

Glioblastoma

NCT03970447

Q4 2035

Phase 1/2Recruiting

Adolescent

NCT06208657

Clinical

Trials by Indication[1]

Glioblastoma3 trials

Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma

Completed·KKazia Therapeutics Limited·Phase 2·NCT03522298·30 enrolled

Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma

Suspended·WWeill Medical College of Cornell University·Phase 2·NCT05183204·33 enrolled

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Recruiting·GGlobal Coalition for Adaptive Research·Preclinical·NCT03970447·2,250 enrolled

Tumour1 trial

5G-PEARL: Paxalisib in Malignant Brain Tumours

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT07391215·64 enrolled

Recurrent or Refractory1 trial

Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL

Recruiting·—·Phase 2·NCT04906096·25 enrolled

Adolescent1 trial

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

Recruiting·AAustralian & New Zealand Children's Haematology/Oncology Group·Phase 1/2·NCT06208657·90 enrolled

Diffuse Intrinsic Pontine Glioma1 trial

A Combination Therapy Trial Using an Adaptive Platform Design for Children and Young Adults With Diffuse Midline Gliomas (DMGs) Including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT05009992·360 enrolled

1 more indication

Atypical Teratoid/Rhabdoid Tumor1 trial

A Platform Study of Novel Therapies for Children, Adolescents and Young Adults With Recurrent/Progressive Atypical Teratoid Rhabdoid Tumor (ATRT)

Recruiting·SSabine Mueller, MD, PhD·Phase 2·NCT07447076·29 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Paxalisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Paxalisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Paxalisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Kazia Therapeutics Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: KKazia Therapeutics Limited

Paxalisib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2029

Q2 2030

Q4 2035

Trials by Indication[1]

Glioblastoma3 trials

Tumour1 trial

Recurrent or Refractory1 trial

Adolescent1 trial

Diffuse Intrinsic Pontine Glioma1 trial

Atypical Teratoid/Rhabdoid Tumor1 trial

References

Drug Info

Quick Facts

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