Serabelisib
As of the edition of 20 October 2026, Serabelisib is a small molecule: in active development; acts on PIK3CA.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Small molecule
- Registered trials
- 13, 3 stopped early
- Disease areas
- Cancer; Inherited and neonatal; Nervous system; Pregnancy and women's health; Skin and connective tissue; Urinary and reproductive
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 on route A because of this drug.
Companies on route A for this drug
In the product1 company is on route A because of Serabelisib.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PIK3CA | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform | P42336 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 4 | 0 | 2 |
| Phase 2 | 7 | 3 | 2 | 1 |
| All trials | 13 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Takeda | Lead sponsor of trials | 2011 to now |
| Petra Pharma | Lead sponsor of trials | 2020 to now |
| Sensei Biotherapeutics | Lead sponsor of trials | 2022 to now |