Takhzyro(lanadelumab)
Takhzyro (lanadelumab) is an antibody pharmaceutical. Lanadelumab was first approved as Takhzyro on 2018-08-23. It has been approved in Europe to treat hereditary angioedemas. The pharmaceutical is active against plasma kallikrein.
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Commercial
Trade Name
FDA
EMA
Takhzyro
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| takhzyro | Biologic Licensing Application | 2024-04-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
lanadelumab, Takhzyro, Takeda Pharmaceuticals U.S.A., Inc. | |||
| 2030-02-03 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0593 | Injection, lanadelumab-flyo, 1 mg (code may be used for medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered) |
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Angioedema | D000799 | EFO_0005532 | T78.3 | 2 | — | 8 | — | 10 | 20 |
| Hereditary angioedemas | D054179 | EFO_0004131 | — | 2 | — | 8 | — | 9 | 19 |
| Covid-19 | D000086382 | — | — | 2 | 1 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hereditary autoinflammatory diseases | D056660 | — | — | — | 1 | — | — | — | 1 |
| Familial mediterranean fever | D010505 | — | M04.1 | — | 1 | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | — | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | — | 1 |
| Lung injury | D055370 | — | S27.30 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lanadelumab |
| INN | lanadelumab |
| Description | Lanadelumab, sold under the brand name Takhzyro, is a human monoclonal antibody (class IgG1 kappa) that targets plasma kallikrein (pKal) in order to promote prevention of angioedema in people with hereditary angioedema. Lanadelumab, was approved in the United States as the first monoclonal antibody indicated for prophylactic treatment to prevent hereditary angioedema attacks. Lanadelumab is the first treatment for hereditary angioedema prevention made by using cells within a lab, not human plasma.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545189 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14597 |
| UNII ID | 2372V1TKXK (ChemIDplus, GSRS) |
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Takhzyro – Takeda
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Additional graphs summarizing 381 documents
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Safety
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Adverse Events
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2,725 adverse events reported
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