BeneFIX
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | BeneFIX | — | 1997-08-27 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03186677 | Jun 2017 → Oct 2018 | hemophilia B | ISU Abxis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02213250 | Mar → Apr 2015 | hemophilia B | Pfizer | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03091751 | Aug 2005 → Oct 2009 | hemophilia B | Grifols Biologicals, LLC | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT01507896 | Dec 2011 → May 2014 | hemophilia B | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01335061 | Sep 2011 → Apr 2014 | hemophilia B | Pfizer | Completed | Met primary |
| Phase 3 | NCT01286779 | Apr 2011 → Jun 2017 | hemophilia B | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT00866606 | Feb → Dec 2009 | hemophilia B | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00364182 | May 2007 → Oct 2010 | hemophilia B | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00037557 | Sep 2002 → Nov 2007 | hemophilia B | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00093210 | ? → Sep 2005 | hemophilia B | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00093171 | ? → May 2005 | hemophilia B | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT04286412 | Feb → Sep 2020 | hemophilia B | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT03565237 | Dec 2018 → Aug 2021 | hemophilia B | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT02336178 | Jan 2015 → Jul 2016 | hemophilia B | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00581126 | Dec 2001 → Jul 2004 | hemophilia B | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT00768287 Comparator | Jan 2009 → Mar 2013 | hemophilia B | Medexus Pharma, Inc. | Completed | Met primary |
| Phase 3 | NCT01174446 Comparator | Jul 2010 → May 2012 | hemophilia B | Baxalta now part of Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-06-15 | Takeda | Results Takeda Provides Updates on its Hemophilia Studies at WFH 2020, Reinforcing its Commitment to Putting Patients First and Supporting Personalized Care for People with Bleeding Disorders takeda.com ↗
The study showed that 86.6% (123/142) of hemostatic effectiveness assessments for nonacog gamma were reported as good or excellent |
| 2016-03-08 | Pfizer | Results Pfizer Announces Publication of Study Results of BeneFIX® Coagulation Factor IX (Recombinant) Once-Weekly Prophylaxis for Hemophilia B pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced the publication of the Phase 3 study results of a once-weekly regimen of BeneFIX ® Coagulation Factor IX (recombinant) 100 IU/kg prophylaxis versus on-demand treatment in people with moderately severe or severe hemophilia B. |
All press releases naming this drug 4 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BeneFIX | “The purpose of this post-approval study is to provide supplementary information relating to the use of BeneFIX in Chinese subjects with hemophilia B, especially on the safety...” NCT02336178 ↗12“To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.” NCT00581126 ↗ “Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B” NCT00093210 ↗ “Study Evaluating rFIX; BeneFIX® in Hemophilia B” NCT00093171 ↗ “Benefix IV each 12 hours for 2 a 5 days” NCT00581126 ↗ “Drug: BENEFIX” NCT02213250 ↗ |
| Known as | BAX 326 | “This phase 3, prospective, open-label, multicenter, continuation study (NCT01286779) investigated the use of a recombinant factor IX (FIX), nonacog gamma (BAX 326, RIXUBIS®) in...” PMID 32866032 ↗ Jan 2020 |
| Known as | Nonacog Alfa | “An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B” NCT00866606 ↗6“Nonacog alfa is a recombinant factor IX (FIX) product indicated for treatment and prevention of bleeding episodes in patients with haemophilia B.” PMID 26196195 ↗ Dec 2015 “Nonacog alfa is a recombinant factor IX (FIX) product indicated for treatment and prevention of bleeding episodes in patients with haemophilia B.” PMID 26196195 ↗ Dec 2015 “An Open-label, Single Dose Pharmacokinetic Study Of BeneFIX (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B” NCT02213250 ↗ |
| Known as | Nonacog gamma | “This phase 3, prospective, open-label, multicenter, continuation study (NCT01286779) investigated the use of a recombinant factor IX (FIX), nonacog gamma (BAX 326, RIXUBIS®) in...” PMID 32866032 ↗ Jan 20201“a recombinant factor IX concentrate, nonacog gamma (BAX 326, Rixubis® [Baxalta US Inc., a Takeda company, Lexington, MA, USA])” PMID 32816519 ↗ Jan 2020 |
| Known as | rFIX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00093210 ↗ |
| Known as | RIXUBIS | “This phase 3, prospective, open-label, multicenter, continuation study (NCT01286779) investigated the use of a recombinant factor IX (FIX), nonacog gamma (BAX 326, RIXUBIS®) in...” PMID 32866032 ↗ Jan 2020 |
| Action | Restore | “FIX replacement therapies” PMID 40750723 ↗ Aug 2025 |
| Modality | Protein / enzyme biologic | “Recombinant Human Factor IX (rFIX; BeneFIX®)” NCT00037557 ↗ |
| Route | Intravenous | “Benefix IV each 12 hours for 2 a 5 days” NCT00581126 ↗ |