Paxalisib

Phase 2Small molecule

KKazia Therapeutics Limited

Paxalisib is one of 50 small molecule programs targeting Diffuse Intrinsic Pontine Glioma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Diffuse Intrinsic Pontine GliomaRecruiting

AdolescentRecruiting

Primary Central Nervous System LymphomaRecruiting

TumourRecruiting

Diffuse Intrinsic Pontine GliomaPhase 2

Recruiting

AdolescentPhase 2

Recruiting

Primary Central Nervous System LymphomaPhase 2

Recruiting

TumourPhase 2

Recruiting

Competition

Competitive Landscape

30 competitors in Adolescent

#DrugCompanyPhaseTrials

Zoloft

VViatris Specialty LLC

Approved

4 2

Abilify

Otsuka

Approved

2 3

Prozac

VVitae Pharmaceuticals Inc., an Allergan affiliate

Phase 3

8 4

Lithobid

SSolvay Pharmaceuticals

Phase 3

2 5

Camptosar

Pfizer

Phase 2

1 6

Brintellix

Takeda

Phase 2

1 7

Sunlenca

Gilead

Phase 2

1 8

Cymbalta

Jazz Pharmaceuticals

Phase 2

1 9

Valdoxan

Novartis

Phase 3

1 10

Zyprexa

MMODAG GmbH

Phase 2

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

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Primary Central Nervous System Lymphoma

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

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

A Phase 2 Trial of Paxalisib Combined With a Ketogenic Diet and Metformin for Newly Diagnosed and Recurrent Glioblastoma

Completed·WWeill Medical College of Cornell University·Phase 2·NCT05183204·24 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

Tumour1 trial

5G-PEARL: Paxalisib in Malignant Brain Tumours

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

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

Primary Central Nervous System Lymphoma1 trial

A Phase 2 Study of Paxalisib (GDC-0084) in Recurrent or Refractory Primary Central Nervous System Lymphoma (PCNSL)

Recruiting·LLakshmi Nayak, MD·Phase 2·NCT04906096·25 enrolled

1 more indication

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

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

Adolescent1 trial

Tumour1 trial

Atypical Teratoid/Rhabdoid Tumor1 trial

Primary Central Nervous System Lymphoma1 trial

Diffuse Intrinsic Pontine Glioma1 trial

References

Drug Info

Quick Facts

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