Paxalisib
As of the edition of 20 October 2026, Paxalisib is a small molecule: in active development; acts on PIK3CA, PIK3CB and PIK3CD and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Small molecule
- Registered trials
- 14, 1 stopped early
- Disease areas
- Cancer; Nervous system; Blood and lymph; Bones, joints and muscles; Immune system; Inherited and neonatal
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Paxalisib.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| PIK3CD | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform | O00329 |
| PIK3CA | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform | P42336 |
| PIK3CB | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform | P42338 |
| PIK3CG | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform | P48736 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 9 | 1 | 6 | 1 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 14 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Roche | Lead sponsor of trials | 2012 to now |
| Kazia Therapeutics | Lead sponsor of trials | 2018 to now |
| Sovargen | Lead sponsor of trials | 2026 to now |