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Exdensur (DEPEMOKIMAB)
Exdensur works by binding to histamine, preventing it from interacting with its receptors and reducing inflammation and airway constriction.
At a glance
| Generic name | DEPEMOKIMAB |
|---|---|
| Sponsor | Glaxosmithkline Llc |
| Target | Histamine |
| Modality | Monoclonal antibody |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Depemokimab‑ulaa is an IL‑5 antagonist (humanized IgG1 kappa monoclonal antibody), which binds to IL‑5 with a dissociation constant of 10.5 pM, inhibiting the bioactivity of IL‑5 with in vitro IC50 value of 4 pM by blocking its binding to the alpha chain of the IL‑5 receptor complex expressed on the cell surface. Depemokimab‑ulaa contains a triple amino acid substitution (YTE) in the fragment crystallizable (Fc) region which increases binding to the neonatal Fc receptor and thereby extends the elimination half‑life. These properties support the dosing interval of every 6 months. IL‑5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation.
Approved indications
- severe asthma
- acute bronchospasm
- status asthmaticus
Common side effects
- Upper respiratory tract infection
- Allergic rhinitis
- Influenza
- Arthralgia
- Pharyngitis
- Injection site reactions
- Erythema
- Swelling
- Itching
Key clinical trials
- A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma (PHASE3)
- Depemokimab Asthma Imaging and Bronchoscopy Sub-Study (PHASE3)
- An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (PHASE3)
- Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (PHASE3)
- eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (PHASE3)
- Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) (PHASE3)
- A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Exdensur CI brief — competitive landscape report
- Exdensur updates RSS · CI watch RSS
- Glaxosmithkline Llc portfolio CI