Risovalisib
As of the edition of 20 October 2026, Risovalisib 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
- 5, 1 stopped early
- Disease areas
- Cancer; Hormones; Pregnancy and women's health; Urinary and reproductive; Inherited and neonatal; 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.
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 | 3 | 1 | 0 | 1 |
| Phase 2 | 2 | 0 | 2 | 0 |
| All trials | 5 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Haihe Biopharma | Lead sponsor of trials | 2018 to now |