Last reviewed 2026-04-19 · How we verify

[14C]-Paxalisib Capsule

Kazia Therapeutics Limited · Phase 1 active Small molecule

[14C]-Paxalisib Capsule is a Small molecule drug developed by Kazia Therapeutics Limited. It is currently in Phase 1 development. Also known as: Phosphoinositide 3-kinase (PI3K) Inhibitor.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	[14C]-Paxalisib Capsule
Also known as	Phosphoinositide 3-kinase (PI3K) Inhibitor
Sponsor	Kazia Therapeutics Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

[14C]-Paxalisib Capsule CI brief — competitive landscape report
[14C]-Paxalisib Capsule updates RSS · CI watch RSS
Kazia Therapeutics Limited portfolio CI

Frequently asked questions about [14C]-Paxalisib Capsule

What is [14C]-Paxalisib Capsule?

[14C]-Paxalisib Capsule is a Small molecule drug developed by Kazia Therapeutics Limited.

Who makes [14C]-Paxalisib Capsule?

[14C]-Paxalisib Capsule is developed by Kazia Therapeutics Limited (see full Kazia Therapeutics Limited pipeline at /company/kazia-therapeutics-limited).

Is [14C]-Paxalisib Capsule also known as anything else?

[14C]-Paxalisib Capsule is also known as Phosphoinositide 3-kinase (PI3K) Inhibitor.

What development phase is [14C]-Paxalisib Capsule in?

[14C]-Paxalisib Capsule is in Phase 1.

Manufacturer: Kazia Therapeutics Limited — full pipeline
Also known as: Phosphoinositide 3-kinase (PI3K) Inhibitor

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing