Drugs / Emicizumab
Emicizumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | HEMLIBRA | — | 2018-10-04 | fda.gov ↗ |
| Approved | EU (EMA) | Hemlibra | — | 2018-02-23 | europa.eu ↗ |
| Approved | US (FDA) | HEMLIBRA | — | 2017-11-16 | fda.gov ↗ |
Trials 26 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05500807 | Nov 2022 → Jun 2027 expected | von Willebrand disease 3 | Bleeding and Clotting Disorders Institute Peoria, Illinois | Recruiting | No outcome recorded |
| Phase 1 | NCT03380780 | Mar → Sep 2018 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05345197 | Aug 2022 → Jul 2026 overdue | acquired hemophilia A | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04188639 | Mar 2021 → Jan 2023 | acquired hemophilia A | GWT-TUD GmbH | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06938659 | Jun 2025 → May 2026 overdue | hemophilia A | Dhaka Medical College | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07439055 | Jun 2025 → Mar 2026 overdue | hemophilia A | Chulalongkorn University | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT06155955 | Jun 2023 → Mar 2024 | hemarthrosis, severe hemophilia A | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT06998524 | Jun 2025 → Apr 2027 expected | von Willebrand disease 3 | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT04030052 | Feb 2022 → Jan 2023 | hemophilia A | Emory University | Withdrawn | No outcome recorded |
| Phase 3 | NCT04303572 | Nov 2021 → Jun 2022 | severe hemophilia A | Margaret Ragni | Terminated | No outcome recorded |
| Phase 3 | NCT04303559 | Oct 2021 → Apr 2022 | hemophilia A | Margaret Ragni | Terminated | No outcome recorded |
| Phase 3 | NCT04431726 | Feb 2021 → May 2023 overdue | severe hemophilia A | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02196207 | Aug 2020 → Jul 2027 | severe hemophilia A | Margaret Ragni | Withdrawn | No outcome recorded |
| Phase 3 | NCT04158648 | Feb 2020 → Oct 2021 | mild hemophilia A, moderately severe hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03315455 | Apr 2018 → Aug 2022 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03191799 | Sep 2017 → Nov 2020 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03020160 | Jan → Dec 2017 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02847637 | Sep 2016 → Sep 2017 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02795767 | Jul 2016 → Apr 2018 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02622321 | Nov 2015 → Oct 2016 | hemophilia A | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT04567511 | Jul 2022 → Jul 2025 overdue | hemophilia A | Indiana Hemophilia &Thrombosis Center, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT05181618 | Jun 2022 → Dec 2026 expected | moderately severe hemophilia A, severe hemophilia A | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03921294 | May 2019 → Mar 2022 | hemophilia A with vascular abnormality | Indiana Hemophilia &Thrombosis Center, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT03361137 | Jun 2018 → Mar 2020 | hemophilia A | Genentech, Inc. | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05279924 | Jul 2021 → Oct 2022 | hemophilia A | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03154437 | — | hemophilia A | Genentech, Inc. | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT04563520 Background | Jun 2026 → Mar 2027 expected | hemophilia A | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT07416604 Comparator | Apr 2026 → Feb 2028 expected | hemophilia A | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07158606 Background | Oct 2025 → Dec 2030 expected | hemophilia A | Versiti Blood Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06145373 Background | Mar 2024 → May 2028 expected | hemophilia A | Sanofi | Recruiting | No outcome recorded |
| Phase 4 | NCT04690322 Comparator | Apr 2021 → Jul 2027 | hemophilia A | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT04621916 Comparator | Sep 2020 → Sep 2024 | hemophilia A | Children's Hospital Los Angeles | Unknown | No outcome recorded |
Press releases naming this drug 31 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-12-09 | Roche Global Development | New data reinforce the benefit of early preventative treatment with Roche’s Hemlibra for babies with severe haemophilia A roche.com ↗ |
| 2023-02-01 | Roche Global Development | European Commission approves label expansion of Roche’s Hemlibra to include people with moderate haemophilia A in the EU roche.com ↗ |
| 2022-12-16 | Roche Global Development | CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A roche.com ↗ |
| 2022-12-11 | Roche Global Development | Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth roche.com ↗ |
| 2022-07-11 | Roche Global Development | New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche’s Hemlibra in people with moderate or mild haemophilia A roche.com ↗ |
| 2021-12-13 | Roche Global Development | Interim data from phase III HAVEN 6 study demonstrate favourable safety and efficacy profile of Roche’s Hemlibra in people with moderate or mild haemophilia A roche.com ↗ |
| 2021-07-19 | Roche Global Development | New data for Roche’s Hemlibra reinforce safety profile in people with haemophilia A roche.com ↗ |
| 2020-12-07 | Roche Global Development | New follow-up phase III data reinforce the long-term benefit of Roche’s Hemlibra for people with haemophilia A roche.com ↗ |
| 2020-07-13 | Roche Global Development | New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A roche.com ↗ |
| 2019-07-09 | Roche Global Development | Roche presents a broad range of data for Hemlibra demonstrating continued benefits for people with haemophilia A at the ISTH 2019 Congress roche.com ↗ |
| 2019-03-14 | Roche Global Development | European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2019-02-01 | Roche Global Development | CHMP recommends EU approval of Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-12-03 | Roche Global Development | Roche's Hemlibra provided sustained bleed control in the largest pivotal study to date of children with haemophilia A with factor VIII inhibitors roche.com ↗ |
| 2018-08-30 | Roche Global Development | Positive phase III results for Roche's Hemlibra for haemophilia A without factor VIII inhibitors published in New England Journal of Medicine roche.com ↗ |
| 2018-06-05 | Roche Global Development | FDA grants Priority Review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-05-21 | Roche Global Development | Roche’s Hemlibra reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in haemophilia A without factor VIII inhibitors roche.com ↗ |
| 2018-05-14 | Roche Global Development | Roche to present new phase III data for Hemlibra in people with haemophilia A at the World Federation of Hemophilia 2018 World Congress roche.com ↗ |
| 2018-04-17 | Roche Global Development | FDA grants Breakthrough Therapy Designation for Roche’s Hemlibra in haemophilia A without inhibitors roche.com ↗ |
| 2018-03-28 | Roche Global Development | Roche announces Japanese court ruled in favour of Chugai in Hemlibra patent litigation roche.com ↗ |
| 2018-02-27 | Roche Global Development | European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors roche.com ↗ |
| 2018-01-26 | Roche Global Development | CHMP recommends EU approval of Roche’s Hemlibra for people with haemophilia A with inhibitors roche.com ↗ |
| 2017-12-09 | Roche Global Development | Roche’s Hemlibra continued to substantially reduce bleeds in people with haemophilia A with inhibitors roche.com ↗ |
| 2017-12-07 | Roche Global Development | Roche’s Hemlibra every four weeks controlled bleeds in phase III study in haemophilia A roche.com ↗ |
| 2017-11-20 | Roche Global Development | Roche’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A roche.com ↗ |
| 2017-11-16 | Roche Global Development | FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors roche.com ↗ |
| 2017-08-24 | Roche Global Development | FDA grants Priority Review to Roche’s emicizumab for haemophilia A with inhibitors roche.com ↗ |
| 2017-07-10 | Roche Global Development | Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine roche.com ↗ |
| 2017-07-09 | Takeda | Shire Obtains Injunction Against Roche to Address Incomplete and Misleading Statements Regarding Investigational Agent Emicizumab That May Impact Patient Safety takeda.com ↗ |
| 2017-06-26 | Roche Global Development | Roche’s emicizumab showed positive results in phase III studies (HAVEN 1 and HAVEN 2) in haemophilia A with inhibitors roche.com ↗ |
| 2017-04-17 | Roche Global Development | Roche announces positive interim results for emicizumab in phase III study of children with haemophilia A roche.com ↗ |
| 2016-12-22 | Roche Global Development | Roche’s emicizumab for haemophilia A meets primary endpoint in phase III study roche.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | emicizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07439055 ↗30 |
| Known as | ACE910 | “Emicizumab (ACE910), a recombinant humanized bispecific monoclonal antibody, provides factor VIII (FVIII) cofactor bridging function to restore hemostasis in people with hemophilia A.” PMID 29296836 ↗ Sep 2017 |
| Known as | Emicizumab kxwh | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833393 ↗ |
| Known as | HEMLIBRA | “Emicizumab (Hemlibra, Roche, Basel, Switzerland) is a novel, bispecific, monoclonal antibody which can substitute for the function of activated FVIII by bringing activated...” NCT04621916 ↗3“randomized to preemptive weekly Eloctate (rFVIIIFc) vs. weekly Emicizumab (Hemlibra) to prevent inhibitor formation” NCT04303559 ↗ “"Emicizumab", "HEMLIBRA®"” NCT06155955 ↗ |
| Known as | HEMLIBRA- emicizumab injection, solution | “HEMLIBRA- emicizumab injection, solution” NCT04690322 ↗ |
| Action | Restore | “Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII” PMID 28691557 ↗ Jul 2017 |
| Modality | Monoclonal antibody | “Emicizumab is the first bispecific monoclonal antibody prophylactic therapy for PwHA” PMID 35939785 ↗ Dec 2022 |
| Route | Subcutaneous | “will be administered by subcutaneous injection” NCT02196207 ↗ |