Advate

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Hemophilia aHemophiliaVon Willebrand Disease

35 competitors in Hemophilia a

#DrugCompanyPhaseTrials

1

Hemlibra

Roche

Approved

162

Rayos

RRoxane Laboratories

Approved

13

Cyklokapron

JJ Molner

Approved

—4

Efanesoctocog Alfa

Sanofi

Phase 3

75

Marstacimab

Pfizer

Phase 3

16

Qfitlia

GGenzyme, a Sanofi Company

Phase 3

17

Advate

Takeda

Phase 3

48

Rfviia

Roche

Phase 3

29

PF-06741086

Pfizer

Phase 3

210

SCT800

SSinocelltech Ltd.

Phase 3

4Show 10 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Hemophilia A4 trials

ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

Completed·BBaxalta now part of Shire··NCT02078427·951 enrolled

Prospective Biomarkers of Bone Metabolism in Hemophilia A

Completed·OOregon Health and Science University·Phase 3·NCT02306694·16 enrolled

A Study of ADVATE in People With Hemophilia A in India

Completed·BBaxalta now part of Shire·Phase 4·NCT04985682·50 enrolled

Show 1 more trial

Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)

Recruiting·RRunhui WU·Phase 4·NCT06864975·110 enrolled

Severe Hemophilia a4 trials

A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)

Completed·BBioverativ, a Sanofi company·Phase 1/2·NCT03205163·16 enrolled

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

Completed·BBioverativ Therapeutics Inc.·Phase 3·NCT01181128·165 enrolled

Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate

Completed·Bayer·Phase 1·NCT02483208·18 enrolled

Show 1 more trial

Evaluate Efficacy and Safety of ADVATE in the Standard Prophylaxis Treatment of Severe or Moderately Severe Hemophilia A

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·N/A·NCT02282410·15 enrolled

Coagulation3 trials

A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

Completed·JJiangsu Gensciences lnc.·Phase 1·NCT05251090·13 enrolled

A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Unknown status·KKaifeng Pharmaceutical (Group) Co., Ltd.··NCT03747653·12 enrolled

A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Completed·JJiangsu Gensciences lnc.·Phase 1·NCT04864743·13 enrolled

Haemophilia A2 trials

Subclinical Joint Bleeding in Irish Adults With Severe Haemophilia A on Personalised Prophylaxis Regimens

Unknown status·SSt. James's Hospital, Ireland·Phase 4·NCT02314325·20 enrolled

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

Completed·Novo Nordisk·Phase 1·NCT00837356·23 enrolled

Hemophilia1 trial

Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

Completed·BBaxalta now part of Shire··NCT02190149·64 enrolled

2 more indications

Von Willebrand disease1 trial

A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)

Recruiting·Takeda·Phase 3·NCT07129343·20 enrolled

Von Willebrand Disease (VWD)1 trial

A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis With Vonicog Alfa (rVWF) in Children Diagnosed With Severe Von Willebrand Disease

Recruiting·Takeda·Phase 3·NCT05582993·24 enrolled

Details

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