human coagulation factor x
Trade name: Coagadex
BiologicalapprovedOrphan Drug FDA
Approved
Apr 29, 2013
Coagulation factor X, or Stuart factor, is an enzyme of the coagulation cascade, encoded in humans by F10 gene. It is a serine endopeptidase. Factor X is synthesized in the liver and requires vitamin K for its synthesis. — Wikipedia
Clinical trial activity
4 trials · 4 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
4
Phase 3
4
Phase 4
0
Earliest trial started Jan 1, 2010 (NCT00930176)
Timeline
2000s
- Nov 8, 2007
Orphan Drug Designation
2010s
- Jan 1, 2010
Bio Products Laboratory — Earliest Phase 3 Sponsor(trial)
- Apr 29, 2013
Earliest FDA Approval
- Oct 20, 2015
Bio Products Laboratory — First NDA Organization
- Oct 20, 2015
Bio Products Laboratory — NDA Organization
- May 3, 2018
AstraZeneca — NDA Secondary Org
Indications
Studied for
Mechanism of action
- Coagulation factor XAGONIST
F10 agonist
- Coagulation factor XEXOGENOUS PROTEIN
Coagulation factor X exogenous protein
Approval history
- approvedApr 29, 2013
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFactor X ↗
- NCATS0P94UQE6SY ↗
- ChEMBLCHEMBL4297951 ↗
- WikipediaFactor_X ↗
Also known as
- coagadex
- coagulation factor x
- coagulation factor x human
- coagulation factor x (human)
- coagulation factor x (human)
- factor x
- factor x
- factor x (stuart prower factor)
- human coagulation factor x
- human coagulation factor x
- human coagulation factor x
- stuart-prower factor
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06963216 | Phase 3 | Dec 31, 2025 | Kedrion SpA, Worldwide Clinical Trials |
| NCT01721681 | Phase 3 | Apr 1, 2015 | Bio Products Laboratory, University of London |
| NCT01086852 | Phase 3 | Mar 1, 2011 | Bio Products Laboratory |
| NCT00930176 | Phase 3 | Jan 1, 2010 | Bio Products Laboratory |
Showing 4 of 4 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bio Products Laboratory | For profit | 3 | 3 | 1 | 2010 |
| Kedrion SpA | For profit | 1 | 1 | 1 | 2025 |
| University of London | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Worldwide Clinical Trials | For profit | 1 | 0 | 1 | 2025 |
4 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | NDA2 | May 3, 2018 |
| Bio Products Laboratory | For profit | NDA | Oct 20, 2015 |