Drug Type Recombinant coagulation factor |
Synonyms eptacog beta, eptacog beta (activated), EPTACOG BETA ACTIVATED + [6] |
Target |
Mechanism tissue factor inhibitors(Tissue factor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (01 Apr 2020), |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Intraoperative blood loss | EU | 15 Jul 2022 | |
Intraoperative blood loss | IS | 15 Jul 2022 | |
Intraoperative blood loss | LI | 15 Jul 2022 | |
Intraoperative blood loss | NO | 15 Jul 2022 | |
Hemophilia A | MX | LFB USA, Inc.Startup | 02 Jun 2022 |
Hemophilia B | MX | LFB USA, Inc.Startup | 02 Jun 2022 |
Hemophilia | US | 01 Apr 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | US | 25 Aug 2016 | |
Hemorrhage | Phase 3 | MX | 25 Aug 2016 | |
Hemorrhage | Phase 3 | RU | 25 Aug 2016 | |
Hemorrhage | Phase 3 | ZA | 25 Aug 2016 | |
Hemorrhage | Phase 3 | ES | 25 Aug 2016 | |
Hemorrhage | Phase 3 | UA | 25 Aug 2016 |
Phase 3 | 27 | Eptacog Beta (Factor VIIa, Recombinant) 75µg/kg | bkjkvyubjo(wuxxulxlcs) = nupaxuwtwr yguwjshaqm (wurdtlxebv ) View more | Positive | 17 Jul 2021 | ||
Eptacog Beta (Factor VIIa, Recombinant) 225µg/kg | bkjkvyubjo(wuxxulxlcs) = dzseuijout yguwjshaqm (wurdtlxebv ) View more | ||||||
Phase 3 | 25 | Initial dose of 75µg/kg Eptacog Beta | owlfbbyvjh(hjhdstlcyz) = skpvoljoaf fqmsbukarx (zpnjllswrs ) | Positive | 17 Jul 2021 | ||
Initial dose of 225µg/kg Eptacog Beta | owlfbbyvjh(hjhdstlcyz) = untejhtsux fqmsbukarx (zpnjllswrs ) | ||||||
Phase 3 | 12 | (MInor procedure) | fvmzqpbrkm(kekfyadqpn) = llnklzwgqz kvdooqnyny (dpnbavqngn, 48 - 100) | Positive | 05 Nov 2020 | ||
(Major procedure) | fvmzqpbrkm(kekfyadqpn) = stmkipunlf kvdooqnyny (dpnbavqngn, 23 - 96) View more | ||||||
Phase 3 | 25 | (Coagulation Factor VIIa (Recombinant): 75 µg/kg) | lnmjpppgbu(sqeospasxc) = ailaqkrxhg jbwtnjgvyl (vnrocfnjzq, jpfzffkhgv - ohdtwsiwtf) View more | - | 28 Aug 2020 | ||
(Coagulation Factor VIIa (Recombinant): 225 µg/kg) | lnmjpppgbu(sqeospasxc) = oitanwcuze jbwtnjgvyl (vnrocfnjzq, ycgllqogej - plekhezoyl) View more | ||||||
Phase 3 | 12 | (Major Surgery (LR769 Initial Dose 200 μg/kg; Then 75 μg/kg)) | ztqqlhgviq(ydndevrmun) = jdemxhncmj ekpuljtulc (ermxehljon, jqupyohloj - ibnfhntrsy) View more | - | 06 Sep 2019 | ||
(Minor Surgery (LR769 Initial Dose 75 μg/kg; Then 75 μg/kg)) | ztqqlhgviq(ydndevrmun) = xinchxkknl ekpuljtulc (ermxehljon, mduguvtnev - nyezcdjyjh) View more | ||||||
Phase 3 | 27 | (75 μg/kg) | nuqyelyoby(cntououvag) = evsnqcrftd ojklytcemi (xmpexgobvn, 74.0 ~ 95.7) | Positive | 01 Nov 2017 | ||
(225 μg/kg) | nuqyelyoby(cntououvag) = jsdyjpsfsw ojklytcemi (xmpexgobvn, 88.1 ~ 98.3) |