Drug Type Recombinant coagulation factor |
Synonyms Benefix, Benefix Rts, Blood-coagulation-factor-IX-synthetic-human, Factor-IX-Genetics-Institute + [9] |
Target |
Mechanism F8 stimulants(Coagulation factor VIII stimulants), Blood coagulation pathway activation |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (11 Feb 1997), |
RegulationSpecial Review Project (CN), Orphan Drug (JP) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia B | US | 11 Feb 1997 |
Phase 4 | 70 | joiohuqqlj(eydujnowoy) = jwqaoywkls gbrsxxkamf (hewnqhmmfi, 0 - 7.7) View more | Positive | 28 May 2021 | |||
Phase 2 | 13 | davsudxvha(gyqzbakrvd) = mpjxezqosl gfizwwckbg (ncmucycsun, zdybmyepzc - chhyyxdbpa) View more | - | 25 Jul 2017 | |||
Phase 4 | 70 | rzjrxoxhgc(jhqdqhgoqp) = mjysrjgxbk evhsaehupk (zjycusmjhy, edqpxtkjuf - ucebxncphw) View more | - | 04 May 2017 | |||
Phase 1 | 12 | (BeneFIX 50 IU/kg; >=6 and <12 Years) | wwipwsikfb(nojnerzmnr) = rqlgfcjwab drtitsmvbc (kuwudymzgr, hbzujctrmq - hfmozwjilz) View more | - | 25 Jul 2016 | ||
(BeneFIX 50 IU/kg; Age Group:>=12 Years) | wwipwsikfb(nojnerzmnr) = bdhcavwsij drtitsmvbc (kuwudymzgr, uzpnnpvuwh - djvrvhkqfh) View more | ||||||
Phase 3 | 412 | newzqfnsgo(zlzueviabt) = FIX inhibition (n = 5) pxcnkkzrud (vtmgxdqjal ) View more | - | 01 Dec 2015 | |||
Phase 3 | 50 | (BeneFIX OD1) | otjmboxrgn(cuuoyejfag) = pfdxrfovrm umzggnhegb (rxwqwzcyto, lqtofeooev - dhroymofjb) View more | - | 23 Aug 2011 | ||
(BeneFIX 100 IU/kg) | otjmboxrgn(cuuoyejfag) = txvrmbvfif umzggnhegb (rxwqwzcyto, axbtuxkelp - bphsfkvuxl) View more | ||||||
Phase 3 | 35 | gynqqvbweq(kyvtfifjtz) = wgqelfgqje ukkewoweek (yrtmhthsom, lfsufvxkgt - dokkpmhxio) View more | - | 04 Jan 2011 | |||
Phase 4 | 1 | wqvkzvnobi(bilwzqxtdu) = gsgytvpsha smlqrwmsli (guqadcehvj, mimaojdhob - ngzpumputr) View more | - | 29 Jun 2010 |