Adbry, Adtralza(tralokinumab)
Adbry, Adtralza (tralokinumab) is an antibody pharmaceutical. Tralokinumab was first approved as Adtralza on 2021-06-17. It is used to treat atopic dermatitis in the USA. It has been approved in Europe to treat atopic dermatitis.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Adbry
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tralokinumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Adbry | tralokinumab-ldrm | LEO Pharma | N-761180 RX | 2021-12-27 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adbry | Biologic Licensing Application | 2024-05-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
40 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 5 | 11 | 1 | 5 | 22 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | 1 | 5 | 11 | 1 | 5 | 22 |
| Eczema | D004485 | HP_0000964 | L30.9 | 1 | 4 | 10 | 1 | 3 | 19 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 4 | 4 | — | — | 12 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | 2 | — | — | — | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 2 | — | — | — | 2 |
| Pulmonary fibrosis | D011658 | — | — | — | 2 | — | — | — | 2 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 1 | — | — | — | 1 |
| Alopecia | D000505 | HP_0002293 | L64 | — | 1 | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tralokinumab |
| INN | tralokinumab |
| Description | Tralokinumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 5L6Y |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743081 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12169 |
| UNII ID | GK1LYB375A (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Tralokinumab – AstraZeneca
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,098 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,626 adverse events reported
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