Alpelisib
As of the edition of 20 October 2026, Alpelisib is a small molecule: marketed, first approved in 2019 (US); acts on PIK3CA; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Piqray
- First approved
- 24 May 2019 (US)
- Approvals on record
- 13 in 3 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 99, 20 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Inherited and neonatal; Hormones; Digestive system; Nervous system
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Novartis.
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 product20 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 20 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 Alpelisib.
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 | 7 | 2 | 0 | 1 |
| Phase 1 | 36 | 24 | 6 | 5 |
| Phase 2 | 47 | 10 | 23 | 11 |
| Phase 3 | 8 | 1 | 4 | 3 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 99 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2019 to now |