Ecallantide
As of the edition of 20 October 2026, Ecallantide is a protein: marketed, first approved in 2009 (US); acts on KLKB1; US protection ended in 2021.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Protein
- Brand name
- Kalbitor
- First approved
- 1 December 2009 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Takeda
- Registered trials
- 10, 3 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Inherited and neonatal; Skin and connective tissue; Eye
US protection
US protection ended in 2021.
US protection ended in 2021, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Takeda. The date is computed, not published.
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 Ecallantide.
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 |
|---|---|---|
| KLKB1 | Plasma kallikrein | P03952 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 5 | 3 | 0 | 2 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Acquired holder and Lead sponsor of trials | 2003 to now |