emicizumab
Trade name: Hemlibra
mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA
Approved
Nov 16, 2017
Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai. Emicizumab is a bispecific factor IXa- and factor X-directed antibody. — Wikipedia
Clinical trial activity
31 trials · 28 clinical orgs · 2 marketing orgs
Phase 1
4
Phase 2
15
Phase 3
15
Phase 4
8
Earliest trial started Dec 31, 2013
Timeline
2010s
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Coagulation factor VIIIINHIBITOR
F8 inhibitor
Coagulation factor IX and X other
Binds to and bridges activated factor IX (factor IXa) and factor X, thereby acting as a factor VIII¿mimetic agent
Very weak antigen-binding affinity
Approval history
- approvedPriority reviewBreakthroughNov 16, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL3833393 ↗
- WikipediaEmicizumab ↗
- NCATS7NL2E3F6K3 ↗
Also known as
- ace910
- emicizumab
- emicizumab
- emicizumab
- emicizumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07158606 | Phase 4 | Oct 1, 2025 | Versiti |
| NCT06998524 | Phase 3 | Jun 27, 2025 | Roche |
| NCT06938659 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2025 | Dhaka Medical College |
| NCT06145373 | Phase 1 | Dec 15, 2023 | Sanofi |
| NCT06155955 | Phase 2/Phase 3 (Phase 3) | Jun 22, 2023 | Chulalongkorn University |
| NCT05500807 | Phase 1 | Nov 30, 2022 | Bleeding and Clotting Disorders Institute, Genentech |
| NCT06320626 | Phase 4 | Sep 8, 2022 | Erasmus University Rotterdam, HagaZiekenhuis, Leiden University, Maastricht University, Radboud University, University of Amsterdam, University of Groningen, Utrecht University |
| NCT05345197 | Phase 2 | Aug 31, 2022 | Genentech, University of Washington |
| NCT05181618 | Phase 4 | Jun 20, 2022 | Roche |
| NCT04563520 | Phase 3 | Dec 31, 2021 | Emory University, Takeda |
| NCT05279924 | N/A | Jul 1, 2021 | Université catholique de Louvain |
| NCT04690322 | Phase 4 | Apr 15, 2021 | The University of Texas, Dallas |
| NCT04567511 | Phase 4 | Mar 31, 2021 | Genentech, Indiana Hemophilia & Thrombosis Center |
| NCT04431726 | Phase 3 | Dec 16, 2020 | Roche |
| NCT04621916 | Phase 4 | Sep 21, 2020 | Children's Hospital Los Angeles, Grifols |
| NCT04303572 | Phase 3 | Jun 30, 2020 | Health Resources and Services Administration (HRSA), University of Pittsburgh |
| NCT04303559 | Phase 3 | Jun 30, 2020 | Health Resources and Services Administration (HRSA), University of Pittsburgh |
| NCT04188639 | Phase 2 | May 31, 2020 | Gottfried Wilhelm Leibniz Universität Hannover, GWT-TUD GmbH, Roche |
| NCT04158648 | Phase 3 | Dec 16, 2019 | Roche |
| NCT04030052 | Phase 3 | Jul 31, 2019 | Emory University |
Showing 20 of 31 trials
Page 1 / 2
Organizations
Research & Development (28)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 14 | 11 | 5 | 2015 |
| Genentech | For profit | 6 | 2 | 4 | 2017 |
| Chugai | For profit | 5 | 1 | 2 | 2013 |
| Emory University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Health Resources and Services Administration (HRSA) | Government | 2 | 0 | 1 | 2020 |
| Indiana Hemophilia & Thrombosis Center | Academic/Hospital | 2 | 2 | 1 | 2019 |
| University of Pittsburgh | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Bleeding and Clotting Disorders Institute | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Children's Hospital Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Chulalongkorn University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Dhaka Medical College | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Grifols | For profit | 1 | 0 | 1 | 2020 |
| GWT-TUD GmbH | For profit | 1 | 1 | 1 | 2020 |
| HagaZiekenhuis | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Leiden University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Maastricht University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Radboud University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Sanofi | For profit | 1 | 1 | 1 | 2023 |
28 organizations
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