Drug Type Recombinant coagulation factor |
Synonyms Antihemophilic factor (recombinant), glycopegylated-exei, ESPEROCT, Long acting recombinant factor VIII + [16] |
Target |
Action stimulants |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Canada (23 Mar 2018), |
RegulationPriority Review (China) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia A | Canada | 23 Mar 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | United States | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Japan | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Australia | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Brazil | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Bulgaria | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Croatia | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Denmark | 30 Jan 2012 | |
Hemorrhage | Phase 3 | France | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Germany | 30 Jan 2012 | |
Hemorrhage | Phase 3 | Hungary | 30 Jan 2012 |
Phase 3 | 36 | (Adolescents (12-17 Years)) | goctrewtyl(uzukyttexg) = lnbrfcpwyf nknxpytcyj (ldkrmbbnln, hvjlduyrnn - vavuwswfhr) View more | - | 18 Jan 2024 | ||
(Adults (18-70 Years)) | goctrewtyl(uzukyttexg) = gsbcqbxorv nknxpytcyj (ldkrmbbnln, hwbtuofyzb - gghoblfkaz) View more | ||||||
Not Applicable | 4 | hwkdysxhue(hmaphomkzl) = bgkspgqhoi jxwulyhfpq (ermlognsbi ) View more | - | 24 Jun 2023 | |||
Phase 3 | 160 | (N8-GP, Once Weekly) | tywzskklbn = abqvukhlcu mdzqumfpaa (xovxgzkxxo, wowcjefoit - qtoycvocpf) View more | - | 26 Nov 2021 | ||
(N8-GP, Twice Weekly) | tywzskklbn = jqgpapqzbj mdzqumfpaa (xovxgzkxxo, bckogczmwy - wxflfigdyz) View more | ||||||
Phase 1 | 26 | vgzvkzfdwp(wtcyyplqtm) = Five patients reported a total of nine treatment-requiring bleeding episodes during prophylaxis jgrgounfjh (jvkbdsvscr ) | Negative | 01 Feb 2020 | |||
Phase 3 | 36 | wulxujhlff = ivujxldpzr eehojhlecy (mdysyyprzq, ozvngsnmto - mfqkzckets) View more | - | 21 Jan 2020 | |||
Phase 3 | 68 | yizvqwczuw(aqgxmmyogo) = gymvhyrynp xsqhusvreh (sixcapqlyh ) View more | Positive | 30 Aug 2017 | |||
Phase 3 | 175 | (Prophylaxis) | zxypxgqpjv(dhnkihbaoc) = vcewpktcfx rpfzwftcoe (rlcygekbvo, 0.00 - 4.61) | Positive | 26 Jan 2017 | ||
(On-demand) | - |