Efanesoctocog alfa

Phase 3Small molecule

Sanofi

Efanesoctocog alfa is one of 43 small molecule programs targeting Haemophilia A. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Haemophilia aRecruiting

Physical ActivityActive, not recruiting

Hemophilia aRecruiting

HypertrophyActive, not recruiting

Haemophilia aPhase 3

Recruiting

Physical ActivityPreclinical

Active, not recruiting

Hemophilia aPhase 3

Recruiting

HypertrophyPhase 3

Active, not recruiting

Competition

Competitive Landscape

35 competitors in Hemophilia a

#DrugCompanyPhaseTrials

Hemlibra

Roche

Approved

16 2

Rayos

RRoxane Laboratories

Approved

1 3

Cyklokapron

Efanesoctocog alfa

7 5

Advate

Takeda

Phase 3

4 6

Marstacimab

Pfizer

Phase 3

1 7

Qfitlia

GGenzyme, a Sanofi Company

Phase 3

1 8

Rfviia

Roche

Phase 3

2 9

PF-06741086

Pfizer

Phase 3

2 10

SCT800

SSinocelltech Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Hypertrophy

NCT06752850

Q1 2027

Phase 3Active, not recruiting

Hemophilia a

NCT04644575

Phase 3Recruiting

Haemophilia a

NCT06716814

Q4 2027

Post-ApprovalRecruiting

Hemophilia a

NCT06941870

Q4 2028

ApprovedRecruiting

Hemophilia a

NCT06940830

Clinical

Trials by Indication[1]

Hemophilia A7 trials

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan

Recruiting· Sanofi logo

Sanofi··NCT06684314·100 enrolled

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A

Active, not recruiting· Sanofi logo

Sanofi··NCT05911763·200 enrolled

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

Completed·BBioverativ, a Sanofi company·Phase 3·NCT04759131·74 enrolled

Show 4 more trials

Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT06941870·35 enrolled

A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

Active, not recruiting·BBioverativ, a Sanofi company·Phase 3·NCT04644575·261 enrolled

A Low-interventional Study to Evaluate Long-term Effectiveness of Real-world Prophylactic Treatment With Efanesoctocog Alfa on Joint Health in People With Haemophilia A (ALTITUDE)

Recruiting·SSwedish Orphan Biovitrum·Approved·NCT06940830·250 enrolled

An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A.

Completed·SSwedish Orphan Biovitrum·Phase 1·NCT06579144·24 enrolled

Severe Hemophilia a2 trials

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

Completed·BBioverativ, a Sanofi company·Phase 3·NCT04161495·159 enrolled

Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A

Completed· Sanofi logo

Sanofi·Phase 1·NCT05042440·13 enrolled

Von Willebrand disease1 trial

To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

Completed·BBioverativ, a Sanofi company·Phase 1·NCT04770935·6 enrolled

Physical Activity1 trial

Goal Attainment and Physical Activity in People With Hemophilia A

Terminated· Sanofi logo

Sanofi··NCT06530030·3 enrolled

Hypertrophy1 trial

A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

Active, not recruiting·SSwedish Orphan Biovitrum·Phase 4·NCT06752850·37 enrolled

2 more indications

Hemophilia A, Severe1 trial

A Phase 3b Open-label Study Evaluating Physical Activity and Joint Health in Previously Treated Patients ≥12 Years With Severe Haemophilia A Treated With Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (Efanesoctocog Alfa) for 24 Months

Completed·SSwedish Orphan Biovitrum·Phase 3·NCT05817812·93 enrolled

Haemophilia A1 trial

A Multinational, Prospective, Open-label, Roll-over Study (LIBERTY) to Provide Post-trial Access to Treatment for Patients With Haemophilia A Who Have Completed a Previous Trial With Efanesoctocog Alfa

Recruiting·SSwedish Orphan Biovitrum·Phase 3·NCT06716814·104 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Efanesoctocog alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Efanesoctocog alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Efanesoctocog alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Sanofi

Efanesoctocog alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Hemophilia A7 trials

Severe Hemophilia a2 trials

Von Willebrand disease1 trial

Physical Activity1 trial

Hypertrophy1 trial

Hemophilia A, Severe1 trial

Haemophilia A1 trial

References

Drug Info

Quick Facts

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