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Drug

Nonacog alfa

Approved · EMA
Emerging researchLate-stage development
Also known as BeneFIX, Ixinity, Mononine, Rixubis+9 more

BeneFIX, Ixinity, Mononine, Rixubis, COAGULATION FACTOR IX RECOMBINANT HUMAN, Coagulation Factor IX (Recombinant), Coagulation factor IX, recombinant, FACTOR IX,RECOMBINANT, Factor IX (Recombinant), Factor IX, recombinant, Recombinant coagulation factor IX, Recombinant factor IX, factor IX human recombinant, threonine 148.

RxNorm1300488UNII382L14738L
2
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF 8 WEEKS.

Clinical trial2022-07-01Results posted · ClinicalTrials.gov

BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures

Clinical trial2021-05-19Results posted · ClinicalTrials.gov

Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Clinical trial2021-04-06Results posted · ClinicalTrials.gov

Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients.

Research2017-08-17Haemophilia : the official journal of the World Federation of Hemophilia

A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)

Clinical trial2015-06-08Results posted · ClinicalTrials.gov

Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study.

Research2014-04-03Haemophilia : the official journal of the World Federation of Hemophilia

A Multicenter, Open-Label Study To Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) In Subjects With Severe Hemophilia B

Clinical trial2011-10-04Results posted · ClinicalTrials.gov

Approval: BeneFIX (EMA)

Regulatory1997-08-27EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nonacog alfa
Aliases & brands
BeneFIXIxinityMononineRixubisCOAGULATION FACTOR IX RECOMBINANT HUMANCoagulation Factor IX (Recombinant)Coagulation factor IX, recombinantFACTOR IX,RECOMBINANTFactor IX (Recombinant)Factor IX, recombinantRecombinant coagulation factor IXRecombinant factor IXfactor IX human recombinant, threonine 148
RxNorm CUI
1300488
UNII
382L14738L
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1997-08-27
Latest approval
1997-08-27
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
1997-08-27Approval
Approval: BeneFIX (EMA)

Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

5 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
5
registered trials across all phases
LATEST COMPLETION 2020
5
Late-stage (III+)
5
Completed
PHASE DISTRIBUTIONn = 5
Phase 2 / 31Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF 8 WEEKS.

CompletedPH IVPfizern=252020

Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

CompletedPH II/IIIMedexus Pharma, Inc.n=772016

BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures

CompletedPH IIIBaxalta now part of Shiren=302014

A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)

CompletedPH IIIPfizern=252014

A Multicenter, Open-Label Study To Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) In Subjects With Severe Hemophilia B

CompletedPH IIIPfizern=502010

Recent completions

Trials that read out recently, adding to the completed evidence base.

A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF 8 WEEKS.

CompletedPH IVPfizern=252020

Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

CompletedPH II/IIIMedexus Pharma, Inc.n=772016

BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures

CompletedPH IIIBaxalta now part of Shiren=302014

A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)

CompletedPH IIIPfizern=252014

A Multicenter, Open-Label Study To Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) In Subjects With Severe Hemophilia B

CompletedPH IIIPfizern=502010

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142018
Journals, researchers & institutions
Top journals
  • Haemophilia : the official journal of the World Federation of Hemophilia2
Leading researchers
  • Abbuehl BE1
  • Apte SJ1
  • Babinchak TJ1
  • Chapman M1
  • Chowdary P1
  • Collins PW1
  • Drobic B1
  • Fritsch S1
Leading institutions
free-text, unnormalised
  • Arthur Bloom Haemophilia Centre1
  • Clinical Development and Medical Affairs1
  • Clinical Research1
  • Emory University1
  • Hemophilia Treatment Center1
  • Institute of Hematology and Transfusion Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.