concizumab
mAbapprovedOrphan Drug FDA
Approved
Dec 20, 2024
Clinical trial activity
11 trials · 2 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
5
Phase 3
3
Phase 4
0
Earliest trial started Oct 1, 2010 (NCT01228669)
Timeline
2010s
- Jan 1, 2010
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
Novo Nordisk — Earliest Phase 2 Sponsor(trial)
- Oct 22, 2018
Orphan Drug Designation
- Jan 1, 2019
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
2020s
- Dec 20, 2024
Novo Nordisk — Earliest FDA Approval
- Dec 20, 2024
Novo Nordisk — NDA Organization
- Dec 20, 2024
Novo Nordisk — Marketing Organization
Indications
Mechanism of action
- Tissue factor pathway inhibitorINHIBITOR
TFPI inhibitor
Approval history
- approvedPriority reviewDec 20, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4297730 ↗
Also known as
- concizumab
- concizumab
- concizumab
- mab 2021
- monoclonal antibody 2021
- nnc172-2021
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06234813 | N/A | Apr 6, 2023 | University of Bordeaux |
| NCT05135559 | Phase 3 | Mar 24, 2022 | Novo Nordisk |
| NCT04082429 | Phase 3 | Oct 21, 2019 | Novo Nordisk |
| NCT04083781 | Phase 3 | Oct 21, 2019 | Novo Nordisk |
| NCT03196297 | Phase 2 | Aug 15, 2017 | Novo Nordisk |
| NCT03196284 | Phase 2 | Aug 15, 2017 | Novo Nordisk |
| NCT02490787 | Phase 1 | Sep 10, 2015 | Novo Nordisk |
| NCT01631942 | Phase 1 | Jun 1, 2012 | Novo Nordisk |
| NCT01555749 | Phase 1 | Mar 12, 2012 | Novo Nordisk |
| NCT01228669 | Phase 1 | Oct 1, 2010 | Novo Nordisk |
| NCT04921956 | N/A | — | Novo Nordisk |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 10 | 10 | 4 | 2010 |
| University of Bordeaux | Academic/Hospital | 1 | 1 | 1 | 2023 |
2 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novo Nordisk | For profit | NDA | Dec 20, 2024 |
| Novo Nordisk | For profit | MKTG | Dec 20, 2024 |