Drug

Emicizumab

Approved · EMA

Emerging researchLate-stage development

Also known as Hemlibra.

RxNorm1989794UNII7NL2E3F6K3

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

An Open-label, Single-arm Treatment Study to Investigate the Safety and Tolerability of Switching From Emicizumab to Fitusiran Prophylaxis in Male Participants Aged ≥12 Years of Age With Severe Hemophilia A, With or Without Inhibitors

Clinical trial2026-06-02Results expected Q2 2028 · ClinicalTrials.gov

Comparison of Low Dose Emicizumab and Low Dose Factor VIII as a Prophylaxis in Hemophilia A Patients- a Randomized Control Trial'

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

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

Clinical trial2026-04-29Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-04-27Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-04-03Results expected Q2 2027 · ClinicalTrials.gov

A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors.

Research2019-12-01Blood

Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors.

Research2018-08-01The New England journal of medicine

Accelerated approval: Hemlibra (EMA)

Regulatory2018-02-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Emicizumab

Aliases & brands

Hemlibra

RxNorm CUI

1989794

UNII

7NL2E3F6K3

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-02-23

Latest approval

2018-02-23

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-02-23Accelerated approval

Accelerated approval: Hemlibra (EMA)

Indication: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor… Show full indication

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.