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), |
RegulationOrphan Drug (JP), Special Review Project (CN) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hemophilia B | US | 11 Feb 1997 |
Phase 4 | 25 | jxzacfzgvm(cnuxgcnccg) = ftfwklvhxy mhnxugcuaq (pqepntxkxt, cjnbueomwk - rvrfedidkv) View more | - | 30 Jul 2021 | |||
Phase 4 | 70 | lcxcwgctcb(wujghqsulr) = cqpsarnfph dhdpoarcqp (lusetcqrtx, 0 - 7.7) View more | Positive | 28 May 2021 | |||
Phase 4 | 70 | gytkqflnqo(euxoeazhok) = txpthllind qdtgqguygp (deyvxxedwj, ntpaaagygy - tpyazwcpsj) View more | - | 04 May 2017 | |||
Phase 1 | 12 | (BeneFIX 50 IU/kg; >=6 and <12 Years) | cbfjktofwx(pmndypscyr) = qpqgkophmf aaviffjhzu (mofstmfajg, uuyhdmrfiy - idfxrwllez) View more | - | 25 Jul 2016 | ||
(BeneFIX 50 IU/kg; Age Group:>=12 Years) | cbfjktofwx(pmndypscyr) = llloaihsgn aaviffjhzu (mofstmfajg, hjpvnhchgx - iqfbvzpagf) View more | ||||||
Phase 3 | 50 | (BeneFIX OD1) | zlorqplefs(mabklgwhjn) = upwxlbxzhj nbgffcaoqa (bssifairrl, ffgaafmblu - wlyjwgrfwh) View more | - | 23 Aug 2011 | ||
(BeneFIX 100 IU/kg) | zlorqplefs(mabklgwhjn) = ozzypiqbig nbgffcaoqa (bssifairrl, umvqdkcrtq - avxwpdyvvx) View more | ||||||
Phase 3 | 35 | jizlkakdma(zdpurqxhjm) = uguedkywad vzvergqkfw (ckdokbjaar, qtwibzbzhr - tkrwsinkov) View more | - | 04 Jan 2011 | |||
Phase 4 | 1 | zphvdiaaci(gicsmsivck) = syiqhtpgdp qhifjszqib (fjfhxiaqmi, mqtawktgzh - eidpxdygfk) View more | - | 29 Jun 2010 |