danaparoid sodium
Trade name: orgaran
Approved
Dec 24, 1996
Danaparoid sodium (Orgaran) is an anticoagulant with an antithrombotic action due to inhibition of thrombin generation (TGI) by two mechanisms: indirect inactivation of Factor Xa via AT and direct inhibition of thrombin activation of Factor IX. It also possesses a minor anti-thrombin activity, mediated equally via AT and Heparin Co-factor II producing a ratio of anti-Xa:IIa activity >22. [Meuleman DG. Haemostasis 1992;22:58-65 and Ofosu FA Haemostasis 1992;22:66-72] — Wikipedia
Clinical trial activity
1 trials · 1 clinical orgs · 1 marketing orgs
Earliest trial started May 16, 2019 (NCT03809481)
Timeline
1990s
- Dec 24, 1996
Aspen Pharmaceuticals — Earliest FDA Approval
- Dec 24, 1996
Aspen Pharmaceuticals — NDA Organization
- Dec 24, 1996
Aspen Pharmaceuticals — NDA Secondary Org
2010s
- Jan 1, 2019
Aspen Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
Indications
Studied for
Mechanism of action
- Antithrombin-IIIACTIVATOR
SERPINC1 activator
Inhibits coagulation by activating antithrombin III; ATIII then binds to F10;
Approval history
- approvedDec 24, 1996
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaDanaparoid ↗
- NCATSBI6GY4U9CW ↗
- ChEMBLCHEMBL1201534 ↗
Also known as
- danaparoid
- danaparoid
- danaparoid
- danaparoid
- danaparoid
- danaparoid sodium
- danaparoid sodium
- danaproid
- danaproid sodium
- lomoparan
- org10172
- org 10172
- org-10172
- org-10172
- organon 10172
- orgaran
- orgaran
- orgaran
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03809481 | Phase 3 | May 16, 2019 | Aspen Pharmaceuticals |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Aspen Pharmaceuticals | For profit | 1 | 1 | 1 | 2019 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aspen Pharmaceuticals | For profit | NDA | Dec 24, 1996 |
| Aspen Pharmaceuticals | For profit | NDA2 | Dec 24, 1996 |