Canakinumab
As of the edition of 20 October 2026, Canakinumab is an antibody: marketed, first approved in 2009 (US); acts on IL1B; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Antibody
- Brand name
- Ilaris
- First approved
- 17 June 2009 (US)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 102, 27 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Bones, joints and muscles; Inherited and neonatal; Nutrition and metabolism; Lungs and airways
US protection
US protection ends in 2027.
The orphan exclusivity ends in 2027 (it covers one use only). 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 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 because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Canakinumab.
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 |
|---|---|---|
| IL1B | Interleukin-1 beta | P01584 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 1 | 1 |
| Phase 1 | 12 | 6 | 1 | 4 |
| Phase 2 | 55 | 34 | 7 | 12 |
| Phase 3 | 31 | 20 | 1 | 10 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 102 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2003 to now |