Human c1-esterase inhibitor
As of the edition of 20 October 2026, Human c1-esterase inhibitor is a protein: marketed, first approved in 2008 (US); acts on C1S, F11 and F12 and 1 more; US protection ended in 2025.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Protein
- Brand name
- Cinryze
- First approved
- 10 October 2008 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Takeda; 3 holders in all
- Registered trials
- 20, 3 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Skin and connective tissue; Inherited and neonatal; Nervous system; Lungs and airways
US protection
US protection ended in 2025.
The orphan exclusivity ended in 2025 (it covers one use only). The application that gives this date is held by Takeda.
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-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Human c1-esterase inhibitor.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 2 | 0 | 0 |
| Phase 2 | 10 | 7 | 2 | 0 |
| Phase 3 | 5 | 3 | 0 | 2 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2009 to now |