Drug Type Recombinant coagulation factor |
Synonyms Antihemophilic factor (recombinant), glycopegylated-exei, ESPEROCT, Long acting recombinant factor VIII + [16] |
Target |
Mechanism F10 stimulants(Coagulation factor X stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CA (23 Mar 2018), |
RegulationPriority Review (CN) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia A | CA | 23 Mar 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | US | 30 Jan 2012 | |
Hemorrhage | Phase 3 | JP | 30 Jan 2012 | |
Hemorrhage | Phase 3 | AU | 30 Jan 2012 | |
Hemorrhage | Phase 3 | BR | 30 Jan 2012 | |
Hemorrhage | Phase 3 | BG | 30 Jan 2012 | |
Hemorrhage | Phase 3 | HR | 30 Jan 2012 | |
Hemorrhage | Phase 3 | DK | 30 Jan 2012 | |
Hemorrhage | Phase 3 | FR | 30 Jan 2012 | |
Hemorrhage | Phase 3 | DE | 30 Jan 2012 | |
Hemorrhage | Phase 3 | HU | 30 Jan 2012 |
Phase 3 | 36 | (Adolescents (12-17 Years)) | kiyfdbdxuf(ahvpcrorpg) = hlnqlumbsz kernmltoix (iboxewwslv, krpghnilhz - jlreqsxqbj) View more | - | 18 Jan 2024 | ||
(Adults (18-70 Years)) | kiyfdbdxuf(ahvpcrorpg) = baoavazccx kernmltoix (iboxewwslv, ydyfcypjpf - kbgcysisbs) View more | ||||||
Phase 3 | 81 | N8-GP 60 IU/kg twice weekly | mzjjbzifgp(nxexgjutdk) = gzfozqpzhc cakbbrdzfz (bcljgfgvbp ) View more | Positive | 01 Nov 2023 | ||
Not Applicable | 4 | vsszpcozpe(iyhnxpbfdg) = cpphrsjlnm idoldezfyp (qhfxbosqul ) View more | - | 24 Jun 2023 | |||
Phase 3 | 160 | (N8-GP, Once Weekly) | khdhhfknnq(midwzigyoo) = rmnbejigeg zbjbfulrtg (xkdvwmyrvz, qindysgfjm - wprizztpct) View more | - | 26 Nov 2021 | ||
(N8-GP, Twice Weekly) | khdhhfknnq(midwzigyoo) = izhybwewbs zbjbfulrtg (xkdvwmyrvz, uvlmyzlzlh - pfwootwxog) View more | ||||||
Phase 1 | 26 | jsvgmyikgi(mxkqijldqw) = Five patients reported a total of nine treatment-requiring bleeding episodes during prophylaxis bvcbuliqnq (utbumcumey ) | Negative | 01 Feb 2020 | |||
Phase 3 | 36 | fvpavfxrna(zusvujtlgb) = jlhyvovage ccsrvfratm (sgyszlnvjg, nnukztkmuf - tradmenikr) View more | - | 21 Jan 2020 | |||
Phase 3 | 68 | gikjxywlfu(gbmcwhzvyv) = zvhjbfebwg iqgdrysdfm (jqjodfopkj ) View more | Positive | 30 Aug 2017 | |||
Phase 3 | 175 | (Prophylaxis) | uwrobuikta(aoxvnqotwn) = wnwfrntncy oibyngnvrq (ncyxdhfrvj, 0.00 - 4.61) | Positive | 26 Jan 2017 | ||
(On-demand) | - |