Leniolisib
As of the edition of 20 October 2026, Leniolisib is a small molecule: marketed, first approved in 2023 (US); acts on PIK3CD; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Joenja
- First approved
- 24 March 2023 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Pharming Technologies; 2 holders in all
- Registered trials
- 9, 1 stopped early
- Disease areas
- Immune system; Blood and lymph; Inherited and neonatal
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Pharming Technologies.
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 product3 listings count towards this date. The exact date and each listing are in the product.
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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 Leniolisib.
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 |
|---|---|---|
| PIK3CD | Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform | O00329 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 4 | 2 | 2 | 0 |
| Phase 3 | 5 | 1 | 2 | 1 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pharming Technologies | Originator, Applicant and Lead sponsor of trials | 2016 to now |