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Haemophilia B

5
Pipeline Programs
5
Companies
11
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
5
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Biocorp
BiocorpFrance - Issoire
5 programs
5
Replenine®-VFPhase 31 trial
Replenine®-VFPhase 31 trial
Replenine®-VFPhase 31 trial
Replenine®-VFPhase 31 trial
Replenine®-VFPhase 31 trial
Active Trials
NCT02263469Completed
NCT02250560Completed
NCT02231944Completed
+2 more trials
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
4 programs
Nonacog beta pegolN/A1 trial
Nonacog beta pegolN/A1 trial
Refixia®N/A1 trial
Nonacog beta pegolPHASE_31 trial
Active Trials
NCT03745924Enrolling By Invitation60Est. Dec 2027
NCT03690336Enrolling By Invitation10Est. Oct 2027
NCT03875547Completed28Est. Sep 2025
+1 more trials
Swedish Orphan Biovitrum
1 program
AlprolixN/A1 trial
Active Trials
NCT03655340Completed91Est. Mar 2022
CSL Behring
CSL BehringIL - Bradley
1 program
Observatory of Patients With Haemophilia B Treated by IdElvion®N/A1 trial
Active Trials
NCT05086575Active Not Recruiting222Est. Dec 2027
CSL Seqirus
CSL SeqirusUK - Maidenhead
1 program
Observatory of Patients With Haemophilia B Treated by IdElvion®N/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Novo NordiskNonacog beta pegol
BiocorpReplenine®-VF
BiocorpReplenine®-VF
BiocorpReplenine®-VF
BiocorpReplenine®-VF
BiocorpReplenine®-VF
CSL BehringObservatory of Patients With Haemophilia B Treated by IdElvion®
Novo NordiskRefixia®
Novo NordiskNonacog beta pegol
Novo NordiskNonacog beta pegol
Swedish Orphan BiovitrumAlprolix

Clinical Trials (11)

Total enrollment: 441 patients across 11 trials

NCT05365217Novo NordiskNonacog beta pegol

A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B

Start: May 2022Est. completion: May 202430 patients
Phase 3Completed
NCT02250573BiocorpReplenine®-VF

An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

Start: Dec 2005
Phase 3Completed
NCT02263469BiocorpReplenine®-VF

A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years

Start: Aug 2005
Phase 3Completed
NCT02250560BiocorpReplenine®-VF

A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.

Start: Apr 2000
Phase 3Completed
NCT02231944BiocorpReplenine®-VF

An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

Start: Jul 1997
Phase 3Completed
NCT02263456BiocorpReplenine®-VF

A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B

Start: Jul 1997
Phase 3Completed
NCT05086575CSL BehringObservatory of Patients With Haemophilia B Treated by IdElvion®

Observatory of Patients With Haemophilia B Treated by IdElvion®

Start: Dec 2021Est. completion: Dec 2027222 patients
N/AActive Not Recruiting
NCT03875547Novo NordiskRefixia®

Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Start: Aug 2019Est. completion: Sep 202528 patients
N/ACompleted
NCT03745924Novo NordiskNonacog beta pegol

A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN

Start: Apr 2019Est. completion: Dec 202760 patients
N/AEnrolling By Invitation
NCT03690336Novo NordiskNonacog beta pegol

Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Start: Oct 2018Est. completion: Oct 202710 patients
N/AEnrolling By Invitation
NCT03655340Swedish Orphan BiovitrumAlprolix

A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France

Start: Sep 2018Est. completion: Mar 202291 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.