EXDENSUR
EXDENSUR (depemokimab-ulaa) is an interleukin-5 (IL-5) antagonist indicated for the add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype. It is approved for use in adult and pediatric patients aged 12 years and older. The medication is not intended for the relief of acute bronchospasm or status asthmaticus. Its extended elimination half-life allows for a dosing schedule of every six months.
How EXDENSUR Works
Depemokimab-ulaa is a humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine responsible for the growth, activation, and survival of eosinophils. By blocking IL-5 from binding to its receptor complex on the cell surface, the drug reduces the production and survival of these inflammatory cells. The molecule includes a specific amino acid substitution in its Fc region that increases its binding to the neonatal Fc receptor. This modification extends the drug's elimination half-life, supporting a twice-yearly dosing interval.
Details
- Status
- Prescription
- First Approved
- 2025-12-16
- Routes
- N/A
- Dosage Forms
- INJECTION
EXDENSUR Approval History
What EXDENSUR Treats
1 indicationsEXDENSUR is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EXDENSUR FDA Label Details
ProIndications & Usage
FDA Label (PDF)EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ] . EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.