Nucala(mepolizumab)
Nucala (mepolizumab) is an antibody pharmaceutical. Mepolizumab was first approved as Nucala on 2015-11-04. It is used to treat asthma in the USA. It has been approved in Europe to treat asthma. The pharmaceutical is active against interleukin-5.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Nucala
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nucala | Biologic Licensing Application | 2025-08-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
mepolizumab, Nucala, GlaxoSmithKline LLC | |||
| 2027-09-25 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2182 | Injection, mepolizumab, 1 mg |
Clinical
Clinical Trials
146 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 5 | 15 | 5 | 12 | 38 |
| Pulmonary eosinophilia | D011657 | EFO_0007257 | J82.81 | — | — | 5 | 3 | 5 | 13 |
| Eosinophilia | D004802 | — | D72.1 | 1 | 1 | 2 | 1 | 1 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Churg-strauss syndrome | D015267 | EFO_0007208 | M30.1 | 1 | 2 | 3 | — | 4 | 9 |
| Syndrome | D013577 | — | — | 1 | 2 | 4 | — | 1 | 7 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | — | — | 5 | — | 1 | 6 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 2 | 4 | — | 1 | 6 |
| Eosinophilic granuloma | D004803 | — | C96.6 | — | — | 2 | — | 3 | 5 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | — | 2 | — | 2 | 4 |
| Nasal polyps | D009298 | — | J33 | 1 | 1 | 2 | — | — | 4 |
| Systemic vasculitis | D056647 | — | — | — | — | 2 | — | 1 | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 2 | — | 1 | 3 |
| Virus diseases | D014777 | — | B34 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 3 | — | — | — | 3 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | 2 | — | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | — | — | 1 |
| Eczema | D004485 | — | L30.9 | — | 1 | — | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fasciitis | D005208 | HP_0100537 | M72.9 | 1 | — | — | — | — | 1 |
| Chronic urticaria | D000080223 | — | L50.8 | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Airway remodeling | D056151 | — | — | — | — | — | — | 1 | 1 |
| Dyspnea | D004417 | — | R06.0 | — | — | — | — | 1 | 1 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 1 | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mepolizumab |
| INN | mepolizumab |
| Description | Mepolizumab, sold under the brand name Nucala, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis, and hypereosinophilic syndrome (HES). It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108429 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06612 |
| UNII ID | 90Z2UF0E52 (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
No data
Financial
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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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50,860 adverse events reported
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