Asset profile

paxalisib · Kazia Therapeutics (KZIA)

Indication: intractable epilepsy associated with focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC)
Also known as: SVG103

Company

Kazia Therapeutics Ltd is a biotechnology company focused on pharmaceutical drug development in oncology. The company has a portfolio of development candidates across various technologies targeting multiple cancer indications. Its primary program is Paxalisib,…

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On the calendar

Oct 2026

~ Oct 2026

KZIAKazia Therapeutics

paxalisib: Phase 2 trial NCT03994796 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2026

Dec 1, 2026

in 39 days

KZIAKazia Therapeutics

paxalisib: Phase 2 trial NCT04906096 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Feb 2027

~ Feb 2027

KZIAKazia Therapeutics

paxalisib: Phase 1/Phase 2 trial NCT07287202 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2027

Dec 31, 2027

in 434 days

KZIAKazia Therapeutics

paxalisib: Phase 2 trial NCT05009992 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Jun 2028

~ Jun 2028

KZIAKazia Therapeutics

paxalisib: Phase 2/Phase 3 trial NCT03970447 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Jan 2029

Jan 19, 2029

in 819 days

KZIAKazia Therapeutics

paxalisib: Phase 1/Phase 2 trial NCT07391215 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Dec 2030

~ Dec 2030

KZIAKazia Therapeutics

paxalisib: Phase 1/Phase 2 trial NCT06208657 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2035

Dec 31, 2035

in 3356 days

KZIAKazia Therapeutics

paxalisib: Phase 2 trial NCT07447076 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Timeline

Newest first.

Sep 28, 2026

03:22 PM

KZIAKazia Therapeutics

paxalisib · NCT03994796 registry update

Trial registry changeClinicalTrials.gov

Sep 25, 2026

03:20 PM

KZIAKazia Therapeutics

paxalisib · NCT05183204 registry update

Trial registry changeClinicalTrials.gov Open record

Sep 22, 2026

07:30 PM

KZIAKazia Therapeutics

Kazia Therapeutics: Sovargen doses first patient in Phase 1b/2a trial of paxalisib in FCD T2 and TSC

Trial registry changeCompany press release

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Sep 28, 2026

Primary endpoint metUnknown

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

507 of 558 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

Sovargen Co., Ltd. Not US-listedPartner

KZIAKazia TherapeuticsOwner

Company press release Sep 22, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT05009992	Phase 2	Recruiting	Dec 31, 2027	360	19 of 32 sites in the United States
NCT04906096	Phase 2	Recruiting	Dec 1, 2026	25	2 of 2 sites in the United States
NCT06208657	Phase 1/2	Recruiting	Dec 1, 2030	90	0 of 14 sites in the United States
NCT03994796	Phase 2	Active, not recruiting	Nov 13, 2025	50	435 of 435 sites in the United States
NCT07391215	Phase 1/2	Recruiting	Jan 19, 2029	64	0 of 1 sites in the United States
NCT07447076	Phase 2	Recruiting	Dec 31, 2035	29	2 of 2 sites in the United States
NCT03970447	Phase 2/3	Recruiting	Jun 1, 2028	2250	42 of 63 sites in the United States
NCT05183204	Phase 2	Completed	Aug 10, 2026	24	1 of 1 sites in the United States
NCT07287202	Phase 1/2	Recruiting	Feb 1, 2027	12	0 of 2 sites in the United States
NCT03522298	Phase 2	Completed	Mar 30, 2023	30	6 of 6 sites in the United States