Icatibant
As of the edition of 20 October 2026, Icatibant is a protein: marketed, first approved in 2008 (EU); acts on BDKRB2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Protein
- Brand name
- Firazyr
- First approved
- 11 July 2008 (EU)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Takeda; 2 holders in all
- Registered trials
- 23, 3 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Skin and connective tissue; Inherited and neonatal; Infections; Lungs and airways
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
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 Icatibant.
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 |
|---|---|---|
| BDKRB2 | B2 bradykinin receptor | P30411 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 1 |
| Phase 2 | 5 | 3 | 1 | 1 |
| Phase 3 | 10 | 9 | 1 | 0 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2004 to now |