conestat alfa
Trade name: Ruconest
Recombinant proteinapproved
Approved
Jul 16, 2014
C1-inhibitor is a protease inhibitor belonging to the serpin superfamily. Its main function is the inhibition of the complement system to prevent spontaneous activation but also as the major regulator of the contact system. — Wikipedia
Clinical trial activity
8 trials · 8 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
6
Phase 3
1
Phase 4
2
Earliest trial started Jan 1, 2017 (NCT02869347)
Timeline
2010s
- Jul 16, 2014
Earliest FDA Approval
- Jul 16, 2014
Pharming Group — NDA Secondary Org
- Jul 21, 2014
Salix — First NDA Organization
- Jul 21, 2014
Salix — NDA Organization
- Jan 1, 2017
Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2024
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Plasma protease C1 inhibitorINHIBITOR
SERPING1 inhibitor
- Plasma protease C1 inhibitorEXOGENOUS PROTEIN
Plasma protease C1 inhibitor exogenous protein
Approval history
- approvedJul 16, 2014
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaC1-inhibitor ↗
- NCATS5QS67N4551 ↗
- ChEMBLCHEMBL2108350 ↗
Also known as
- c1 esterase inhibitor (recombinant)
- c1 esterase inhibitor (recombinant)
- c1 inhibitor (recombinant)
- complement c1 esterase inhibitor
- conestat alfa
- conestat alfa
- conestat alfa
- conestat alfa
- conestat alfa
- conestat alpha
- human c1-inhibitor (recombinant, rabbit derived)
- recombinant complement c1 esterase inhibitor
- recombinant human c1 inhibitor
- recombinant human c1 inhibitor
- recombinant human c1-inhibitor
- recombinant human c1-inhibitor
- recombinant human c1-inhibitor
- recombinant human c1-inhibitor rabbit milk derived
- ruconest
- ruconest
- ruconest
- ruconest
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06679426 | Phase 3 | Dec 1, 2024 | University of Cincinnati, University of Maryland |
| NCT05145283 | Phase 2 | Feb 28, 2022 | Pharming Group, Swiss National Science Foundation, University of Basel |
| NCT04912141 | Phase 2 | Apr 21, 2021 | Pharming Group |
| NCT04705831 | Phase 4 | Dec 30, 2020 | IMMUNOe |
| NCT04530136 | Phase 2 | Nov 30, 2020 | Pharming Group, University of Cincinnati |
| NCT04414631 | Phase 2 | Jun 30, 2020 | Pharming Group, University of Basel |
| NCT06690047 | Phase 4 | Aug 14, 2018 | Bernstein Clinical Research Center |
| NCT02869347 | Phase 2 | Jan 1, 2017 | Pharming Group, University of Basel, University of Bern |
Showing 8 of 8 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pharming Group | For profit | 5 | 2 | 1 | 2017 |
| University of Basel | Academic/Hospital | 3 | 2 | 1 | 2017 |
| University of Cincinnati | Academic/Hospital | 2 | 1 | 2 | 2020 |
| Bernstein Clinical Research Center | Academic/Hospital | 1 | 1 | 1 | 2018 |
| IMMUNOe | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Swiss National Science Foundation | Government | 1 | 0 | 1 | 2022 |
| University of Bern | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University of Maryland | Academic/Hospital | 1 | 0 | 1 | 2024 |
8 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pharming Group | For profit | NDA2 | Jul 16, 2014 |
| Salix | For profit | NDA | Jul 21, 2014 |