Apitolisib
As of the edition of 20 October 2026, Apitolisib is a small molecule: in active development; acts on MTOR, PIK3CA and PIK3CB and 2 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2011
- Kind
- Small molecule
- Registered trials
- 12, 0 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Blood and lymph; Immune system; Pregnancy and women's health; Skin and connective tissue
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 Apitolisib.
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 |
| MTOR | Serine/threonine-protein kinase mTOR | P42345 |
| PIK3CG | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform | P48736 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| All trials | 12 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Roche | Lead sponsor of trials | 2009 to now |