Rilonacept
As of the edition of 20 October 2026, Rilonacept is a protein: marketed, first approved in 2008 (US); acts on IL1B; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Protein
- Brand name
- Arcalyst
- First approved
- 27 February 2008 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Kiniksa Pharmaceuticals
- Withdrawn from market
- 24 October 2012 (in some regions)
- Registered trials
- 20, 2 stopped early
- Disease areas
- Inherited and neonatal; Bones, joints and muscles; Skin and connective tissue; Immune system; Nutrition and metabolism; Heart and blood vessels
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Kiniksa Pharmaceuticals.
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 product2 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 and 1 company on route A because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Rilonacept.
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Companies on route A for this drug
In the product1 company is on route A because of Rilonacept.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| IL1B | Interleukin-1 beta | P01584 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 2 | 0 | 0 |
| Phase 2 | 11 | 9 | 1 | 1 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Regeneron | Earlier holder and Lead sponsor of trials | 2005 to now |
| Kiniksa Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2018 to now |