Dupixent(dupilumab)
Dupixent (dupilumab) is an antibody pharmaceutical. Dupilumab was first approved as Dupixent on 2017-03-28. It is used to treat atopic dermatitis in the USA. It has been approved in Europe to treat asthma, atopic dermatitis, esophageal diseases, prurigo, and sinusitis. The pharmaceutical is active against interleukin-4 receptor subunit alpha.
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Commercial
Trade Name
FDA
EMA
Dupixent (discontinued: Dupixent)
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)
Dupilumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Dupixent | dupilumab | Regeneron Pharmaceuticals | N-761055 RX | 2017-03-28 | 4 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dupixent | Biologic Licensing Application | 2024-09-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atopic dermatitis | EFO_0000274 | D003876 | L20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
dupilumab, Dupixent, Regeneron Pharmaceuticals, Inc. | |||
| 2029-05-20 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
262 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | — | L30.9 | 4 | 9 | 13 | 10 | 17 | 52 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 4 | 9 | 12 | 10 | 17 | 51 |
| Eczema | D004485 | — | L30.9 | 2 | 8 | 8 | 7 | 13 | 38 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 4 | 9 | 7 | 7 | 28 |
| Rhinosinusitis | D000096825 | — | — | — | — | 6 | 3 | 3 | 12 |
| Nasal polyps | D009298 | — | J33 | — | 1 | 4 | 3 | 3 | 11 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 2 | 3 | 3 | 2 | 9 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 1 | 2 | 3 | 2 | 8 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | 2 | 2 | 2 | 7 |
| Polyps | D011127 | EFO_0000662 | — | — | — | 2 | 3 | — | 5 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurodermatitis | D009450 | — | L28.0 | — | — | 5 | — | 2 | 7 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 2 | 3 | — | — | 5 |
| Prurigo | D011536 | — | L28.2 | — | — | 3 | — | 2 | 5 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | 2 | — | — | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 2 | 1 | — | — | 3 |
| Allergic fungal sinusitis | D000092562 | — | — | — | — | 2 | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 2 | — | — | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 2 | — | — | 2 |
| Obstructive lung diseases | D008173 | — | — | — | — | 2 | — | — | 2 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | 1 | — | 1 | 2 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peanut hypersensitivity | D021183 | EFO_0007425 | — | — | 2 | — | — | — | 2 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | — | — | — | 1 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 1 | — | — | — | 1 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 1 | — | — | — | 1 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | 1 | — | — | — | 1 |
| Allergic rhinitis | D065631 | — | J30.9 | — | 1 | — | — | — | 1 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 1 | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 1 | — | — | — | 1 |
| Alopecia | D000505 | — | L64 | — | 1 | — | — | — | 1 |
| Pulmonary eosinophilia | D011657 | EFO_0007257 | J82.81 | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | — | H10 | — | — | — | — | 2 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 2 | 2 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | — | — | — | 2 | 2 |
| Pathologic processes | D010335 | — | — | — | — | — | — | 1 | 1 |
| Anosmia | D000086582 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dupilumab |
| INN | dupilumab |
| Description | Dupilumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6WG8:A|Dupilumab Fab heavy chain
EVQLVESGGGLEQPGGSLRLSCAGSGFTFRDYAMTWVRQAPGKGLEWVSSISGSGGNTYYADSVKGRFTISRDNSKNTLY
LQMNSLRAEDTAVYYCAKDRLSITIRPRYYGLDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPE
PVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGHHHHHH
>6WG8:B|Dupilumab Fab light chain
DIVMTQSPLSLPVTPGEPASISCRSSQSLLYSIGYNYLDWYLQKSGQSPQLLIYLGSNRASGVPDRFSGSGSGTDFTLKI
SRVEAEDVGFYYCMQALQTPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ
SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTQGTTSVTKSFNRGEC |
Identifiers
| PDB | 6WG8, 6WGB, 6WGJ, 6WGK, 6WGL |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108675 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12159 |
| UNII ID | 420K487FSG (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
IL4R
IL4R
Organism
Homo sapiens
Gene name
IL4R
Gene synonyms
NCBI Gene ID
—
Protein name
Interleukin 4 receptor
Protein synonyms
Uniprot ID
Mouse ortholog
—
—
Variants
No data
Financial
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Dupixent – Sanofi
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Dupixent – Regeneron Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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278,999 adverse events reported
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