Congenital Bleeding Disorder

59
Pipeline Programs
1
Companies
50
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
30
0
5
0
20
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 83 programs with unclassified modality

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
85 programs
30
5
20
4
activated recombinant human factor VIIPhase 41 trial
activated recombinant human factor VIIPhase 41 trial
eptacog alfaPhase 41 trial
turoctocog alfaPhase 41 trial
Turoctocog alfa pegolPhase 31 trial
+80 more programs
Active Trials
NCT01322620Completed1,236Est. Feb 2012
NCT01988532Completed381Est. Oct 2014
NCT01503567Completed282Est. Sep 2012
+82 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Novo Nordiskturoctocog alfa
Novo Nordiskactivated recombinant human factor VII
Novo Nordiskeptacog alfa
Novo Nordiskactivated recombinant human factor VII
Novo NordiskTuroctocog alfa pegol
Novo Nordiskturoctocog alfa
Novo Nordisknonacog beta pegol
Novo Nordiskturoctocog alfa pegol
Novo Nordiskturoctocog alfa pegol
Novo Nordiskturoctocog alfa
Novo Nordiskturoctocog alfa pegol
Novo Nordisknonacog beta pegol
Novo Nordisknonacog beta pegol
Novo Nordisknonacog beta pegol
Novo Nordiskturoctocog alfa pegol

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 2,292 patients across 50 trials

Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period

Start: Mar 2018Est. completion: Apr 201960 patients
Phase 4Completed
NCT00571584Novo Nordiskactivated recombinant human factor VII

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Start: Nov 2002Est. completion: Mar 200424 patients
Phase 4Completed

Trial of NovoSeven® in Haemophilia - Joint Bleeds

Start: Sep 2001Est. completion: Feb 200642 patients
Phase 4Completed
NCT01561391Novo Nordiskactivated recombinant human factor VII

Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

Start: Apr 1998Est. completion: May 200436 patients
Phase 4Completed
NCT03528551Novo NordiskTuroctocog alfa pegol

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

Start: Apr 2018Est. completion: Dec 2020160 patients
Phase 3Completed

Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

Start: Dec 2016Est. completion: Dec 201868 patients
Phase 3Completed
NCT02141074Novo Nordisknonacog beta pegol

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

Start: Jul 2014Est. completion: Oct 202254 patients
Phase 3Completed
NCT02137850Novo Nordiskturoctocog alfa pegol

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Start: Jun 2014Est. completion: Jun 2023124 patients
Phase 3Completed
NCT01731600Novo Nordiskturoctocog alfa pegol

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Start: Feb 2013Est. completion: Sep 201868 patients
Phase 3Completed

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Start: Sep 2012Est. completion: Dec 201860 patients
Phase 3Completed
NCT01489111Novo Nordiskturoctocog alfa pegol

Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

Start: Aug 2012Est. completion: Dec 201836 patients
Phase 3Completed
NCT01386528Novo Nordisknonacog beta pegol

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

Start: Jun 2012Est. completion: Dec 201313 patients
Phase 3Completed
NCT01467427Novo Nordisknonacog beta pegol

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

Start: May 2012Est. completion: Nov 202325 patients
Phase 3Completed
NCT01395810Novo Nordisknonacog beta pegol

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

Start: Apr 2012Est. completion: Mar 201471 patients
Phase 3Completed
NCT01480180Novo Nordiskturoctocog alfa pegol

Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

Start: Jan 2012Est. completion: Dec 2018186 patients
Phase 3Completed
NCT01392547Novo Nordiskvatreptacog alfa

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

Start: Jul 2011Est. completion: Aug 201272 patients
Phase 3Completed
NCT01333111Novo Nordisknonacog beta pegol

Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

Start: Apr 2011Est. completion: Mar 201374 patients
Phase 3Completed

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

Start: Jan 2011Est. completion: Mar 20156 patients
Phase 3Completed

Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

Start: Nov 2010Est. completion: Jan 20126 patients
Phase 3Completed

Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

Start: Jun 2010Est. completion: Nov 201165 patients
Phase 3Completed

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Start: Oct 2009Est. completion: Jun 2016214 patients
Phase 3Completed

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

Start: Sep 2009Est. completion: Oct 201563 patients
Phase 3Completed

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

Start: Apr 2009Est. completion: Sep 2011150 patients
Phase 3Completed

Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

Start: Aug 2008Est. completion: Apr 201041 patients
Phase 3Completed

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

Start: Aug 2017Est. completion: Jan 202026 patients
Phase 2Completed
NCT02541942Novo NordiskNo treatment given

Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

Start: Apr 2015Est. completion: Apr 201619 patients
Phase 2Completed
NCT00951405Novo Nordiskactivated recombinant human factor VII, long acting

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

Start: Sep 2009Est. completion: Mar 201123 patients
Phase 2Completed

Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

Start: Jun 2007Est. completion: Jun 201051 patients
Phase 2Completed
NCT00108758Novo Nordiskactivated recombinant human factor VII

Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Start: Mar 2004Est. completion: Nov 200523 patients
Phase 2Completed

A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Start: Mar 2017Est. completion: Dec 201715 patients
Phase 1Completed
NCT02994407Novo Nordiskturoctocog alfa pegol

Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

Start: Jan 2017Est. completion: Oct 201850 patients
Phase 1Completed

Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Start: Oct 2016Est. completion: Jun 201735 patients
Phase 1Completed
NCT02920398Novo Nordiskturoctocog alfa pegol

A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

Start: Oct 2016Est. completion: Apr 201721 patients
Phase 1Completed

Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

Start: Sep 2015Est. completion: Oct 201624 patients
Phase 1Completed
NCT02084810Novo Nordiskactivated recombinant human factor VII

Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects

Start: Mar 2014Est. completion: Jul 20140
Phase 1Withdrawn

A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors

Start: Sep 2013Est. completion: Nov 20136 patients
Phase 1Completed

Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

Start: Dec 2012Est. completion: Mar 201315 patients
Phase 1Completed

A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

Start: Jun 2012Est. completion: Sep 20124 patients
Phase 1Terminated

Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects

Start: Mar 2012Est. completion: May 20128 patients
Phase 1Completed

A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

Start: Jun 2011Est. completion: Sep 20114 patients
Phase 1Completed
NCT01288391Novo NordiskNNC 0128-0000-2011

Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients

Start: Jan 2011Est. completion: Jul 201115 patients
Phase 1Completed
NCT01272206Novo NordiskNNC 0128-0000-2011

Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

Start: Jan 2011Est. completion: Mar 201112 patients
Phase 1Completed

A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

Start: Nov 2010Est. completion: Oct 20116 patients
Phase 1Completed
NCT01228669Novo NordiskNNC 0172-0000-2021

Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B

Start: Oct 2010Est. completion: Sep 201252 patients
Phase 1Completed
NCT01205724Novo Nordiskturoctocog alfa pegol

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

Start: Sep 2010Est. completion: Apr 201127 patients
Phase 1Completed

Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

Start: Mar 2010Est. completion: Jul 201051 patients
Phase 1Completed
NCT00956345Novo Nordisknonacog beta pegol

Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

Start: Aug 2009Est. completion: Jul 201018 patients
Phase 1Completed
NCT00951873Novo Nordiskactivated recombinant human factor VII, long acting

A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

Start: Jul 2009Est. completion: Apr 201038 patients
Phase 1Completed
NCT00922792Novo Nordiskactivated recombinant human factor VII, long acting

Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

Start: Jun 2009Est. completion: Sep 20098 patients
Phase 1Completed

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Start: Mar 2009Est. completion: Oct 200923 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

20 late-stage (Phase 3) programs — potential near-term approvals
1 companies competing in this space