Drug Type Bispecific antibody |
Synonyms Coagulation factor VIII mimetic antibody, FVIII mimetic antibody + [5] |
Target |
Mechanism F10 inhibitors(Coagulation factor X inhibitors), factor IXa inhibitors(Factor IXa inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemophilia A | Phase 3 | FR | 02 Dec 2021 | |
Hemophilia A | Phase 3 | SK | 02 Dec 2021 | |
Hemophilia A | Phase 3 | MX | 02 Dec 2021 | |
Hemophilia A | Phase 3 | BE | 02 Dec 2021 | |
Hemophilia A | Phase 3 | IT | 02 Dec 2021 | |
Hemophilia A | Phase 3 | IN | 02 Dec 2021 | |
Hemophilia A | Phase 3 | IE | 02 Dec 2021 | |
Hemophilia A | Phase 3 | ZA | 02 Dec 2021 | |
Hemophilia A | Phase 3 | TR | 02 Dec 2021 | |
Hemophilia A | Phase 3 | NL | 02 Dec 2021 |
Phase 3 | 254 | Mim8 once-weekly prophylaxis (no prior prophylaxis treatment) | (kilcnlhuoa) = zxqosfigqd nfjpjqfblz (hnpfxnojxu ) View more | Positive | 23 Jun 2024 | ||
Mim8 once-monthly prophylaxis (no prior prophylaxis treatment) | (kilcnlhuoa) = hlwypomnjj nfjpjqfblz (hnpfxnojxu ) View more | ||||||
Phase 3 | 254 | Mim8 once-weekly | tnfmtjlnot(dnplxqflbm) = fmzvauqvxq ljjvjpozyd (xwyoztzwcq ) Met View more | Positive | 13 May 2024 | ||
Mim8 once-monthly | tnfmtjlnot(dnplxqflbm) = ibonnirraq ljjvjpozyd (xwyoztzwcq ) Met View more | ||||||
Not Applicable | - | (AAV-Bi8 vector) | ntquuzikwj(juclcptgha) = zjdqzfhxvq gllffutikr (ceaibhhygu ) View more | - | 10 Dec 2023 | ||
Phase 1/2 | 42 | (jfmspbupnw) = xveodxvqzb qxbrkdidwu (jievypfbsv ) View more | Positive | 15 Nov 2022 | |||
Phase 1/2 | - | - | (SAD phase) | (fsfiuvhdvr) = Mim8 was well tolerated following both single and multiple dosing, and no thromboembolic events or related serious adverse events were reported wjcqxcdeve (khskxlshnq ) | Positive | 11 Jul 2022 | |
(MAD phase) |