Chemistry:Depemokimab
Depemokimab, sold under the brand name Exdensur, is a humanized monoclonal antibody used for the treatment of asthma.[1][2] Depemokimab is an interleukin-5 (IL-5) antagonist monoclonal antibody (humanized immunoglobulin G1 [IgG1] kappa).[1] Depemokimab was developed by GSK.[3] It is structurally similar to mepolizumab but contains seven amino acid substitutions in the heavy chain sequence. [4]
Depemokimab was approved for medical use in both the United Kingdom and United States in December 2025.[5][6]
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.[5]
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.[1]
Society and culture
Legal status
Depemokimab was approved for medical use in both the United Kingdom and United States in December 2025.[5][3][7]
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.[8] The applicant for this medicinal product is GlaxoSmithKline Trading Services Limited.[8]
Names
Depemokimab is the international nonproprietary name.[9]
References
- ↑ 1.0 1.1 1.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedExdensur FDA label - ↑ "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. December 2025. doi:10.1097/ACI.0000000000001112. PMID 41158017.
- ↑ 3.0 3.1 "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.
- ↑ "Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody for severe eosinophilic asthma". Med (New York, N.Y.) 5 (12): 1452–1455. 2024. doi:10.1016/j.medj.2024.10.022. PMID 39674169. https://www.sciencedirect.com/science/article/pii/S2666634024004203. Retrieved 28 December 2025.
- ↑ 5.0 5.1 5.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedMHRA PR - ↑ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025.
- ↑ "Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma". GSK US (Press release). 16 December 2025. Retrieved 19 December 2025.
- ↑ 8.0 8.1 "Exdensur EPAR". 12 December 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021.
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
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