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
254 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 | HP_0011123 | L30.9 | 8 | 15 | 21 | 28 | 31 | 101 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 8 | 14 | 19 | 27 | 31 | 98 |
| Eczema | D004485 | HP_0000964 | L30.9 | 4 | 14 | 15 | 22 | 19 | 74 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 7 | 10 | 12 | 15 | 45 |
| Rhinosinusitis | D000096825 | — | — | 1 | 2 | 6 | 8 | 13 | 30 |
| Nasal polyps | D009298 | HP_0100582 | J33 | — | 5 | 4 | 10 | 11 | 30 |
| Sinusitis | D012852 | EFO_0007486 | J32 | 1 | 4 | 2 | 3 | 5 | 15 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 4 | 3 | 4 | 2 | 12 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 2 | 2 | 4 | 2 | 10 |
| Polyps | D011127 | EFO_0000662 | — | — | 1 | 2 | 4 | 3 | 10 |
Show 21 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 |
| Allergic fungal sinusitis | D000092562 | — | — | — | — | 3 | — | — | 3 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | 1 | — | 2 | 3 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | 2 | — | — | 3 |
| Skin diseases | D012871 | — | L00-L99 | 1 | — | 2 | — | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 2 | — | — | 2 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 2 | — | — | 2 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | 2 | — | — | 2 |
Show 16 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Food hypersensitivity | D005512 | EFO_1001890 | — | 2 | 1 | — | — | 2 | 5 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 2 | 3 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | — | — | 2 | 3 |
| Covid-19 | D000086382 | — | — | — | 1 | — | — | 2 | 3 |
| Peanut hypersensitivity | D021183 | EFO_0007425 | — | — | 3 | — | — | — | 3 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 3 | — | — | — | 3 |
| Alopecia | D000505 | HP_0002293 | L64 | — | 3 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | 1 | 3 |
| Paranasal sinus diseases | D010254 | — | — | — | 2 | — | — | — | 2 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | 1 | — | — | — | 2 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 1 | — | — | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | — | — | — | 3 | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 2 | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Conjunctival diseases | D003229 | — | H10-H11 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Anosmia | D000086582 | — | — | — | — | — | — | 1 | 1 |
Show 5 more
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
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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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275,379 adverse events reported
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