Depemokimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Interleukin 5 |
| Clinical data | |
| Trade names | Exdensur |
| Other names | Depemokimab-ulaa, AQ-82742999; GSK 294; GSK3511294 |
| AHFS/Drugs.com | Exdensur |
| License data |
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| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| ChEMBL | |
Depemokimab, sold under the brand name Exdensur, is a humanized monoclonal antibody used for the treatment of asthma.[2][3] Depemokimab is an interleukin-5 (IL-5) antagonist monoclonal antibody (humanized Immunoglobulin G1 [IgG1] kappa).[2] Depemokimab was developed by GSK.[4]
Depemokimab was approved for medical use in both the United Kingdom and United States in December 2025.[1][5]
Medical uses
In the United Kingdom, depemokimab is indicated as an add-on maintenance treatment of asthma in people aged twelve years of age and older with type 2 inflammation characterized by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or high-dose inhaled corticosteroids plus another asthma controller; and as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.[1]
In the United States, depemokimab is indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in people aged twelve years of age and older.[2]
Society and culture
Legal status
Depemokimab was approved for medical use in both the United Kingdom and United States in December 2025.[1][4][6]
In December 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Exdensur, intended for severe eosinophilic asthma and for severe chronic rhinosinusitis with nasal polyps.[7] The applicant for this medicinal product is GlaxoSmithKline Trading Services Limited.[7]
Names
Depemokimab is the international nonproprietary name.[8]
References
- ^ a b c d "UK approves the first twice yearly biological medicine for asthma and severe chronic rhinosinusitis with nasal polyps". Medicines and Healthcare products Regulatory Agency (MHRA) (Press release). 15 December 2025. Retrieved 19 December 2025.
- ^ a b c d https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Exdensur/pdf/EXDENSUR-PI-PIL.PDF
- ^ Bernstein DI (December 2025). "Depemokimab: a new long-acting anti-IL5 treatment for severe asthma and chronic rhinosinusitis with nasal polyps". Current Opinion in Allergy and Clinical Immunology. 25 (6): 488–492. doi:10.1097/ACI.0000000000001112. PMID 41158017.
- ^ a b "Exdensur (depemokimab) approved in the UK for treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps". GSK (Press release). 15 December 2025. Retrieved 19 December 2025.
- ^ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). Retrieved 18 December 2025.
- ^ "Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma". GSK US (Press release). 16 December 2025. Retrieved 19 December 2025.
- ^ a b "Exdensur EPAR". European Medicines Agency (EMA). 12 December 2025. Retrieved 22 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.
External links
- Clinical trial number NCT04719832 for "Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-1)" at ClinicalTrials.gov
- Clinical trial number NCT04718103 for "A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-2)" at ClinicalTrials.gov