Inavolisib
As of the edition of 20 October 2026, Inavolisib is a small molecule: marketed, first approved in 2024 (US); acts on PIK3CA; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Itovebi
- First approved
- 10 October 2024 (US)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 32, 2 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Pregnancy and women's health; Urinary and reproductive; Hormones
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Roche.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product10 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 10 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Inavolisib.
See the 1 company on route B 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 not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 5 | 0 | 5 | 0 |
| Phase 2 | 21 | 2 | 17 | 2 |
| Phase 3 | 5 | 0 | 5 | 0 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Originator, Applicant and Lead sponsor of trials | 2016 to now |