Dactolisib
As of the edition of 20 October 2026, Dactolisib is a small molecule: went quiet in 2021; 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
- Went quiet, 2021
- Kind
- Small molecule
- Registered trials
- 25, 11 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Infections; Inherited and neonatal; Lungs and airways; Nervous system
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 and 9 company-target rows on route A because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Dactolisib.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Companies on route A for this drug
In the product9 company-target rows are on route A because of Dactolisib.
See the 9 company-target rows on route A 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 | 10 | 9 | 0 | 1 |
| Phase 2 | 13 | 1 | 2 | 9 |
| Phase 3 | 2 | 1 | 0 | 1 |
| All trials | 25 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Novartis | Lead sponsor of trials | 2006 to now |
| SCRI Development Innovations | Lead sponsor of trials | 2011 to now |
| Pfizer | Lead sponsor of trials | 2011 to now |
| Restorbio | Lead sponsor of trials | 2017 to now |