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Drug

coagulation factor IX (recombinant), glycopegylated

In clinical development
Emerging researchLate-stage development

Also known as Nonacog beta pegol, Rebinyn, factor IX (human) recombinant, pegylated.

RxNorm1990855UNII27Y83O992Q
4
Research papers
Latest activity
beta

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

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Nonacog Beta Pegol When Used for Treatment and Prophylaxis of Bleeding Episodes in Chinese Patients With Haemophilia B

Clinical trial2026-01-12Results posted · ClinicalTrials.gov

An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

Clinical trial2025-12-23Results posted · ClinicalTrials.gov

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

Clinical trial2025-12-23Results posted · ClinicalTrials.gov

Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B.

Research2020-05-05Thrombosis and haemostasis

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

Clinical trial2018-05-09Results posted · ClinicalTrials.gov

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

Clinical trial2017-08-23Results posted · ClinicalTrials.gov

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

Clinical trial2017-07-28Results posted · ClinicalTrials.gov

Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product.

Research2016-06-28Haemophilia : the official journal of the World Federation of Hemophilia

Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial.

Research2016-06-22Journal of thrombosis and haemostasis : JTH

Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm™4).

Research2016-03-02Thrombosis research

A Multi-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

Clinical trial2010-07-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
coagulation factor IX (recombinant), glycopegylated
Aliases & brands
Nonacog beta pegolRebinynfactor IX (human) recombinant, pegylated
RxNorm CUI
1990855
UNII
27Y83O992Q

Clinical trials

7 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
7
registered trials across all phases
LATEST COMPLETION 2024
6
Late-stage (III+)
7
Completed
PHASE DISTRIBUTIONn = 7
Phase 11Phase 36

Late-stage studies

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

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Nonacog Beta Pegol When Used for Treatment and Prophylaxis of Bleeding Episodes in Chinese Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=302024

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=252023

An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

CompletedPH IIINovo Nordisk A/Sn=542022

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=712014

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=132013

Recent completions

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

A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Nonacog Beta Pegol When Used for Treatment and Prophylaxis of Bleeding Episodes in Chinese Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=302024

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=252023

An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

CompletedPH IIINovo Nordisk A/Sn=542022

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=712014

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=132013

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

CompletedPH IIINovo Nordisk A/Sn=742013

Research activity

4 papers

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

Publications over time
20162020
Most influential

Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm™4).

Thrombosis research · 2016 · 47 cites

Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial.

Journal of thrombosis and haemostasis : JTH · 2016 · 33 cites

Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product.

Haemophilia : the official journal of the World Federation of Hemophilia · 2016 · 22 cites

Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B.

Thrombosis and haemostasis · 2020 · 12 cites
Recent papers

Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B.

Thrombosis and haemostasis · 2020 · 12 cites

Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm™4).

Thrombosis research · 2016 · 47 cites

Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial.

Journal of thrombosis and haemostasis : JTH · 2016 · 33 cites

Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product.

Haemophilia : the official journal of the World Federation of Hemophilia · 2016 · 22 cites
Journals, researchers & institutions
Top journals
  • Haemophilia : the official journal of the World Federation of Hemophilia1
  • Journal of thrombosis and haemostasis : JTH1
  • Thrombosis and haemostasis1
  • Thrombosis research1
Leading researchers
  • Kearney S3
  • Santagostino E3
  • Carcao M2
  • Hanabusa H2
  • Lu MY2
  • Zak M2
  • Abdul Karim F1
  • Chowdary P1
Leading institutions
free-text, unnormalised
  • Angelo Bianchi Bonomi Hemophilia and Thrombosis Center2
  • Ogikubo Hospital2
  • Arthur Bloom Haemophilia Centre1
  • Baylor College of Medicine1
  • Carver College of Medicine1
  • Center for Bleeding and Clotting Disorders1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials