Conestat alfa
As of the edition of 20 October 2026, Conestat alfa is a protein: marketed, first approved in 2010 (EU); US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Protein
- Brand name
- Ruconest
- First approved
- 28 October 2010 (EU)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- CSL Behring; 3 holders in all
- Registered trials
- 21, 0 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Inherited and neonatal; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2026.
The reference-product exclusivity ended in 2026. The application that gives this date is held by Pharming Americas BV.
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.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 2 | 7 | 7 | 0 | 0 |
| Phase 3 | 10 | 10 | 0 | 0 |
| All trials | 21 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Pharming Technologies | Lead sponsor of trials | 2004 to now |
| Takeda | Lead sponsor of trials | 2005 to now |
| CSL Behring | Lead sponsor of trials | 2005 to now |