Wednesday, July 8, 2026

Drug profile · INN

emicizumab

emicizumab (HEMLIBRA) is a coagulation factor ix and x other. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Blood and blood forming organs (B02) B02BX06
US status approved
Patents linked 0
Pipeline programs 6
News articles 0
Drug details — emicizumab
US status
approved
Class
Blood and blood forming organs (B02)
Route
INJECTION
Patents
0
Programs
6
Data quality
0.84

Quick answer

emicizumab (HEMLIBRA) is a coagulation factor ix and x other. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN emicizumab
Brand HEMLIBRA
Mechanism Coagulation factor IX and X other
Target Coagulation factor IX and X
Therapeutic class Blood and blood forming organs (B02)
Route INJECTION
Formulation INJECTABLE
ATC code B02BX06

Mechanism of action

Coagulation factor IX and X other

Primary target: Coagulation factor IX and X

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. BO41423 Phase 3 · HOFFMANN-LA ROCHE · Mild or moderate hemophilia A without FVIII inhibitors
  2. Emicizumab Phase 3 · Takeda · Hemophilia A
  3. MO41787 Phase 3 · HOFFMANN-LA ROCHE · Hemophilia A
  4. SFY17741 Phase 1 · Sanofi-Aventis U.S · Hemophilia A
  5. 22-571/21U-0151 Approved · Disc Medicine · Congenital Haemophilia A
  6. Hemlibra 150 mg/mL solution for injection Approved · HOFFMANN-LA ROCHE · Severe or Moderate Hemophilia A

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. berotralstat Blood and blood forming organs (B06)
  3. bivalirudin Blood and blood forming organs (B01)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)

Frequently asked questions

What is emicizumab?

emicizumab (HEMLIBRA) is a coagulation factor ix and x other. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for emicizumab?

HEMLIBRA is a marketed brand name for emicizumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of emicizumab?

emicizumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.