Severe Haemophilia A

4
Pipeline Programs
3
Companies
4
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Gene Therapy
1100%
+ 3 programs with unclassified modality

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Octapharma
OctapharmaAustria - Vienna
2 programs
2
Human cl rhFVIIIPhase 31 trial
Human-cl rhFVIIIPhase 31 trial
Active Trials
NCT02256917Completed58Est. Sep 2018
NCT01863758Completed66Est. Jan 2015
Swedish Orphan Biovitrum
1 program
1
Efanesoctocog alfaPhase 31 trial
Active Trials
NCT06716814RecruitingEst. Mar 2027
BioMarin Pharmaceutical
1 program
1
valoctocogene roxaparvovecPhase 1/2Gene Therapy1 trial
Active Trials
NCT02576795Completed15Est. Feb 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Swedish Orphan BiovitrumEfanesoctocog alfa
OctapharmaHuman cl rhFVIII
OctapharmaHuman-cl rhFVIII
BioMarin Pharmaceuticalvaloctocogene roxaparvovec

Clinical Trials (4)

Total enrollment: 139 patients across 4 trials

Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

Start: Mar 2025Est. completion: Mar 2027
Phase 3Recruiting
NCT02256917OctapharmaHuman cl rhFVIII

Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

Start: May 2015Est. completion: Sep 201858 patients
Phase 3Completed
NCT01863758OctapharmaHuman-cl rhFVIII

Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A

Start: Aug 2013Est. completion: Jan 201566 patients
Phase 3Completed
NCT02576795BioMarin Pharmaceuticalvaloctocogene roxaparvovec

Gene Therapy Study in Severe Haemophilia A Patients (270-201)

Start: Sep 2015Est. completion: Feb 202415 patients
Phase 1/2Completed

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 139 patients
3 companies competing in this space