factor ix albumin fusion protein
Trade name: Idelvion
Recombinant proteinapprovedOrphan Drug FDA
Approved
Mar 4, 2016
Factor IX, also known as Christmas factor, is one of the serine proteases involved in coagulation; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. — Wikipedia
Clinical trial activity
3 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Oct 1, 2010 (NCT01233440)
Timeline
2010s
- Jan 1, 2010
CSL Behring — Earliest Phase 1 Sponsor(trial)
- Apr 27, 2012
Orphan Drug Designation
- Mar 4, 2016
CSL Behring — Earliest FDA Approval
- Mar 4, 2016
CSL Behring — NDA Organization
2020s
- Jan 1, 2024
CSL Behring — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- Coagulation factor IXAGONIST
F9 agonist
Approval history
- approvedMar 4, 2016
Chemistry & pharmacology
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor IX ↗
Also known as
- factor ix albumin fusion protein
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06399289 | Phase 3 | Jun 28, 2024 | CSL Behring |
| NCT01361126 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2011 | CSL Behring |
| NCT01233440 | Phase 1 | Oct 1, 2010 | CSL Behring |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CSL Behring | For profit | 3 | 3 | 3 | 2010 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| CSL Behring | For profit | NDA | Mar 4, 2016 |