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
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EMA
Hemlibra
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hemlibra | Biologic Licensing Application | 2024-02-07 |
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
46 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 | 4 | 3 | 16 | 9 | 15 | 46 |
| Inherited blood coagulation disorders | D025861 | — | — | — | — | — | 1 | — | 1 |
| Recurrence | D012008 | — | — | — | — | — | 1 | — | 1 |
| Immune tolerance | D007108 | — | — | — | — | — | 1 | — | 1 |
| Adolescent development | D041923 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Von willebrand diseases | D014842 | EFO_0003910 | D68.0 | 1 | — | — | — | 1 | 2 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Type 3 von willebrand disease | D056729 | Orphanet_166096 | D68.03 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Thrombophilia | D019851 | — | D68.59 | — | — | — | — | 1 | 1 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | — | — | 1 | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 1 | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Blood platelet disorders | D001791 | — | — | — | — | — | — | 1 | 1 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 1 | 1 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 1 | 1 |
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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) |
Target
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Hemlibra – Roche
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Trends
PubMed Central
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Additional graphs summarizing 1,152 documents
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Safety
Black-box Warning
Black-box warning for: Hemlibra
Adverse Events
Top Adverse Reactions
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5,356 adverse events reported
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