garadacimab
mAbapprovedOrphan Drug FDA
Approved
Jun 16, 2025
Clinical trial activity
11 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
7
Phase 3
3
Phase 4
1
Earliest trial started Oct 29, 2018 (NCT03712228)
Timeline
2010s
- Jan 1, 2018
CSL Behring — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
CSL Behring — Earliest Phase 1 Sponsor(trial)
- Apr 30, 2020
Orphan Drug Designation
- Jan 1, 2021
CSL Behring — Earliest Phase 3 Sponsor(trial)
- Jun 16, 2025
Earliest FDA Approval
- Jun 16, 2025
CSL Behring — Marketing Organization
Indications
Approved for
Mechanism of action
- Coagulation factor XIIINHIBITOR
F12 inhibitor
Approval history
- approvedJun 16, 2025
Chemistry & pharmacology
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06806657 | Phase 4 | Mar 14, 2025 | CSL Behring |
| NCT05819775 | Phase 3 | May 24, 2023 | CSL Behring |
| NCT05306275 | Phase 1 | Apr 4, 2022 | CSL Behring |
| NCT05130970 | Phase 2 | Jan 31, 2022 | CSL Behring |
| NCT04739059 | Phase 3 | Mar 29, 2021 | CSL Behring |
| NCT04656418 | Phase 3 | Jan 31, 2021 | CSL Behring |
| NCT04580654 | Phase 1 | Oct 29, 2020 | CSL Behring |
| NCT04409509 | Phase 2 | Jun 30, 2020 | CSL Behring |
| NCT04281524 | Phase 1/Phase 2 (Phase 2) | Mar 31, 2020 | CSL Behring |
| NCT03712228 | Phase 2 | Oct 29, 2018 | CSL Behring |
| NCT07159464 | N/A | — | CSL Behring |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| CSL Behring | For profit | 11 | 11 | 5 | 2018 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| CSL Behring | For profit | MKTG | Jun 16, 2025 |