Chemistry:Depemokimab

From HandWiki

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 and the European Union, 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][7]

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

Depemokimab was approved for medical use in both the United Kingdom and United States in December 2025.[5][3][8]

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] Depemokimab was authorized for medical use in the European Union in February 2026.[7][9]

Names

Depemokimab is the international nonproprietary name.[10]

Depemokimab is sold under the brand name Exdensur.

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Exdensur FDA label
  2. ↑ "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. ↑ 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.
  4. ↑ "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. ↑ 5.0 5.1 5.2 Cite error: Invalid <ref> tag; no text was provided for refs named MHRA PR
  6. ↑ "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. 
  7. ↑ 7.0 7.1 7.2 7.3 "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.
  8. ↑ "Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma". GSK US (Press release). 16 December 2025. Retrieved 19 December 2025.
  9. ↑ "Exdensur PI". 16 February 2026. https://ec.europa.eu/health/documents/community-register/html/h2007.htm. 
  10. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021. 
  • 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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