Hemlibra(emicizumab)
Hemlibra (emicizumab) is an antibody pharmaceutical. Emicizumab was first approved as Hemlibra on 2017-11-16. It is used to treat hemophilia a in the USA. It has been approved in Europe to treat hemophilia a. It is known to target coagulation factor IX and coagulation factor X.
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Commercial
Therapeutic Areas
Trade Name
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EMA
Hemlibra
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hemlibra | Biologic Licensing Application | 2025-07-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemophilia a | EFO_0007267 | D006467 | D66 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
emicizumab, Hemlibra, Genentech, Inc. | |||
| 2025-10-04 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7170 | Injection, emicizumab-kxwh, 0.5 mg |
Clinical
Clinical Trials
51 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | 1 | 8 | 1 | 2 | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 3 von willebrand disease | D056729 | Orphanet_166096 | D68.03 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Emicizumab |
| INN | emicizumab |
| Description | Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (a subsidiary of Hoffmann-La Roche). A Phase I clinical trial found that it was well tolerated by healthy subjects.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833393 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13923 |
| UNII ID | 7NL2E3F6K3 (ChemIDplus, GSRS) |
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Hemlibra – Roche
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Estimated US medical usage
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PubMed Central
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Additional graphs summarizing 1,433 documents
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Safety
Black-box Warning
Black-box warning for: Hemlibra
Adverse Events
Top Adverse Reactions
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10,569 adverse events reported
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