Hemlibra

(Emicizumab)

ApprovedMonoclonal antibody

Emicizumab is used to prevent or reduce bleeding episodes in people with hemophilia A, a genetic blood disorder where the body cannot clot properly.[2] Hemlibra is currently approved and in use across 8 indications[4].[1]

Hemlibra is one of 96 bispecific antibody programs targeting Hemophilia A. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Hemophilia aTerminated

Severe Hemophilia aActive, not recruiting

Blood CoagulationUnknown

HemorrhageUnknown

Physical ActivityActive, not recruiting

Hemophilia a With InhibitorNot yet recruiting

HemophiliaRecruiting

Acquired HemophiliaActive, not recruiting

Hemophilia aApproved

Terminated

Severe Hemophilia aApproved

Active, not recruiting

Blood CoagulationPreclinical

Unknown

HemorrhagePreclinical

Unknown

Physical ActivityApproved

Active, not recruiting

Hemophilia a With InhibitorApproved

Not yet recruiting

HemophiliaApproved

Recruiting

Acquired HemophiliaPhase 2

Active, not recruiting

Competition

Competitive Landscape

61 competitors in Hemorrhage

#DrugCompanyPhaseTrials

Hemlibra

Roche

Approved

31 2

Plavix

Savaysa

Prevacid

Eliquis

Bayer Aspirin

Klor-Con

Ketalar

1 9

Coumadin

AAbbott

Approved

1 10

Decadron

AAspen Global Incorporated

Approved

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Acquired Hemophilia

NCT05345197

Q1 2027

Phase 3Recruiting

Hemophilia a

NCT04563520

Q2 2027

Phase 3Recruiting

Hemophilia a

NCT04621916

Phase 1Recruiting

Von Willebrand Disease

NCT05500807

Q3 2027

Post-ApprovalRecruiting

Severe Hemophilia a

NCT04690322

Post-ApprovalRecruiting

Hemophilia a

NCT04567511

Clinical

Trials by Indication[1]

Hemophilia A16 trials

The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

Unknown status·JJW Pharmaceutical··NCT04805801·17 enrolled

Low Dose Emicizumab vs Low Dose Factor VIII in Prophylaxis in Hemophilia A Patients

Not yet recruiting·—·Phase 2/3·NCT06938659·20 enrolled

Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants

Completed· Roche logo

Roche·Phase 3·NCT03315455·85 enrolled

Show 13 more trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT02622321·113 enrolled

Treatment of Hemophilia A Patients With FVIII Inhibitors

Recruiting·EEmory University··NCT04023019·120 enrolled

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A

Completed· Roche logo

Roche·Phase 3·NCT03020160·48 enrolled

An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors

Approved for marketing· Roche logo

Roche··NCT03154437

Hemlibra in Mild Hemophilia A

Recruiting·IIndiana Hemophilia &Thrombosis Center, Inc.·Phase 4·NCT04567511·20 enrolled

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT02795767·88 enrolled

Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures

Terminated· Roche logo

Roche·Phase 4·NCT03361137·14 enrolled

A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT02847637·152 enrolled

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT03191799·195 enrolled

A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A

Recruiting· Roche logo

Roche·Phase 3·NCT07416604·360 enrolled

aPCC and Emicizumab Safety Study in Congenital Hemophilia A Patients With Inhibitors (SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis)

Recruiting·EEmory University·Phase 3·NCT04563520·5 enrolled

Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis -STEP: SporTs Emicizumab Prophylaxis

Recruiting·WWayne State University··NCT05022459·72 enrolled

HAVEN-7: Fitusiran in Hemophilia A

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT04621916·200 enrolled

Severe Hemophilia a4 trials

Unknown status·NNewark Beth Israel Medical Center··NCT06104826·50 enrolled

POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT04690322·28 enrolled

A Multicenter, Open-Label Phase IV Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes, in Participants Aged ≥13 and <70 Years With Severe or Moderate Hemophilia A Without FVIII Inhibitors on Emicizumab Prophylaxis

Active, not recruiting· Roche logo

Roche·Approved·NCT05181618·136 enrolled

Show 1 more trial

A Phase IIIb, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04431726·55 enrolled

Hemophilia3 trials

The Hemophilia Inhibitor Prevention Trial

Terminated·MMargaret Ragni·Phase 3·NCT04303559·1 enrolled

The Hemophilia Inhibitor Eradication Trial

Terminated·MMargaret Ragni·Phase 3·NCT04303572·1 enrolled

A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT06145373·20 enrolled

Acquired Hemophilia2 trials

Emicizumab in Acquired Hemophilia A

Completed·GGWT-TUD GmbH·Phase 2·NCT04188639·47 enrolled

Emicizumab in Patients With Acquired Hemophilia A

Active, not recruiting·UUniversity of Washington·Phase 2·NCT05345197·51 enrolled

Von Willebrand disease1 trial

Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A

Recruiting·BBleeding and Clotting Disorders Institute Peoria, Illinois·Phase 1·NCT05500807·40 enrolled

5 more indications

Tics1 trial

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Completed· Roche logo

Roche·Phase 1·NCT03380780·16 enrolled

Prophylaxis1 trial

HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor

Terminated·IIndiana Hemophilia &Thrombosis Center, Inc.·Phase 4·NCT03921294·1 enrolled

Von Willebrand Disease, Type 31 trial

A Phase III, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Prophylaxis in Patients With Type 3 Von Willebrand Disease

Recruiting· Roche logo

Roche·Phase 3·NCT06998524·75 enrolled

Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor1 trial

A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors

Completed· Roche logo

Roche·Phase 3·NCT04158648·73 enrolled

Hemophilia A With Inhibitor1 trial

Understanding Treatment Outcomes and Immunologic Mechanisms in ALtuviiio Immune Tolerance Induction

Not yet recruiting·VVersiti Blood Health·Approved·NCT07158606·15 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 16, 2017

HEMLIBRA

NDA BLA761083

Nov 16, 2017

HEMLIBRA

BLA BLA761083

Oct 4, 2018

HEMLIBRA

NDA BLA761083

Oct 4, 2018

HEMLIBRA

NDA BLA761083

Sep 2, 2021

HEMLIBRA

NDA BLA761083

Dec 16, 2021

HEMLIBRA

NDA BLA761083

Jun 6, 2022

HEMLIBRA

NDA BLA761083

Jan 31, 2024

HEMLIBRA

NDA BLA761083

Jul 8, 2025

HEMLIBRA

NDA BLA761083

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Emicizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Hemlibra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Emicizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Emicizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761083). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Emicizumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Factor Ixa/x Bispecific[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Roche

Key Publications[6]

Emicizumab Prophylaxis in Hemophilia A Without Inhibitors: HAVEN 3 Final

BloodNov 3, 2022DOI: 10.1182/blood.2022016860

Hemlibra

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Hemophilia A16 trials

Severe Hemophilia a4 trials

Hemophilia3 trials

Acquired Hemophilia2 trials

Von Willebrand disease1 trial

Tics1 trial

Prophylaxis1 trial

Von Willebrand Disease, Type 31 trial

Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor1 trial

Hemophilia A With Inhibitor1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

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