Depemokimab

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.

• 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 ( 5.2 )] .ICD-10: J45.909

• None. None.contraindicated

The recommended dosage is 100 mg administered once every 6 months by subcutaneous (SC) injection into the upper arm, thigh, or abdomen. ( 2.1 ) • EXDENSUR should be administered by a healthcare provider. ( 2.2 ) • See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage is 100 mg once every 6 months administered by subcutaneous (SC) injection into the upper arm, thigh, or abdomen avoiding 2 inches (5 cm) around the navel [see Dosage and Administration ( 2.2 )] . Missed Dose(s) If a dose is missed, administer the missed dose as soon as possible and resume the once every 6‑month injection schedule from the date of when the missed dose was given. 2.2 Preparation and Administration Instructions for EXDENSUR • EXDENSUR is for subcutaneous (SC) use only. • EXDENSUR should be administered by a healthcare provider. Do not use EXDENSUR prefilled pen or syringe if the security seal on the carton has been broken. Do not use EXDENSUR prefilled pen or syringe if it has been dropped or damaged. Preparation Instructions 1. Remove the prefilled pen or prefilled syringe from the refrigerator. Holding the middle of the prefilled pen or prefilled syringe, take it out from the tray and allow it to sit at room temperature for 30 minutes prior to injection. Do not warm EXDENSUR injection in any other way. Do not remove the needle cap until you are ready to inject. Do not use the pen or syringe if it has been left out of the carton for more than 8 hours. 2.

• Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. ( 5.1 ) • Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR. Reduce corticosteroid dose gradually, if appropriate. ( 5.3 ) • Treat pre-existing helminth infections before initiating therapy with EXDENSUR. If patients become infected while receiving treatment with EXDENSUR and do not respond to anti‑helminth treatment, discontinue EXDENSUR until the parasitic infection resolves. ( 5.4 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. 5.2 Acute Asthma Symptoms or Deteriorating Disease EXDENSUR should not be used to treat acute asthma symptoms or acute exacerbations. Do not use EXDENSUR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with EXDENSUR. 5.3 Risk Associated with Abrupt Reduction of Corticosteroid Dosage Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of EXDENSUR therapy.

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EXDENSUR was based on a pooled safety population from 2 replicate, randomized, double‑blind, parallel‑group, placebo‑controlled, multicenter clinical trials (SWIFT‑1 and SWIFT‑2) of 52 weeks duration. The 2 trials included 762 adult and pediatric patients 12 years of age and older with asthma, who received either EXDENSUR 100 mg or placebo administered subcutaneously once every 6 months in addition to their existing background medications for asthma [see Clinical Studies ( 14 )] . A total of 475 patients received 2 doses of EXDENSUR 100 mg in these trials. Adverse reactions with EXDENSUR with incidence of ≥4% are shown in Table 1 . Table 1.

Pregnancy: EXDENSUR can cross the placenta during pregnancy and the presence of the YTE modification may prolong and increase exposure to the infant exposed in utero. The impact of EXDENSUR transmission to the fetus should be considered. ( 8.1 ) 8.1 Pregnancy Risk Summary Available data from clinical trials with EXDENSUR use in pregnant women are insufficient to identify a drug‑associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with asthma in pregnancy (see Clinical Considerations). Transport of endogenous IgG antibodies and monoclonal antibodies, such as depemokimab-ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester. The impact of the YTE modification on placental transfer is uncertain [see Clinical Pharmacology ( 12.1 )] ; however, the presence of the YTE modification may lead to prolonged and increased exposure of the infant exposed in utero , and the potential of clinical impact is unknown and should be considered. No treatment-related effects on embryofetal or postnatal development have been shown in animal studies targeting IL‑5 signaling pathways (see Data) . The background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

Metabolism

The pharmacokinetics of depemokimab‑ulaa were approximately dose‑proportional in patients with asthma following SC administration over a dose range of 0.1‑times the recommended dose to 3‑times the recommended dose. After SC administration of 100 mg of EXDENSUR every 6 months in patients with severe asthma, the mean (SD) model-based estimated trough concentration of depemokimab‑ulaa at Week 26 was approximately 1.30 (0.44) mcg/mL.

If an overdosage occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.

• Dec 16, 2025BLABLA761458Glaxosmithkline Llc

1. 1Asthma633%
2. 2Chest Pain633%
3. 3Cholecystitis Acute211%
4. 4Dry Skin15.6%
5. 5Erythema15.6%
6. 6Gastroenteritis15.6%
7. 7Injection Site Rash15.6%
8. 8Product Prescribing Issue15.6%
9. 9Pruritus15.6%
10. 10Rash Morbilliform15.6%
11. 11Rhinorrhoea15.6%
12. 12Skin Exfoliation15.6%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Depemokimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of GSK3511294 in Healthy Chinese Participants
  Completed · Phase 1 · Interventional · 20 enrolled · GlaxoSmithKline
  NCT05140200updated 2026-05-26
• A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
  Completed · Phase 3 · Interventional · 1,717 enrolled · GlaxoSmithKline
  NCT04718389updated 2026-05-18
• Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
  Recruiting · Phase 3 · Interventional · 150 enrolled · GlaxoSmithKline
  NCT06979323updated 2026-04-23
• Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
  Recruiting · Phase 3 · Interventional · 960 enrolled · GlaxoSmithKline
  NCT06961214updated 2026-04-09
• A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
  Not yet recruiting · Phase 3 · Interventional · 456 enrolled · GlaxoSmithKline
  NCT07456033updated 2026-03-06
• An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
  Completed · Phase 3 · Interventional · 641 enrolled · GlaxoSmithKline
  NCT05243680updated 2026-01-15
• Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
  Completed · Phase 3 · Interventional · 276 enrolled · GlaxoSmithKline
  NCT05274750updated 2025-12-03
• Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
  Recruiting · Phase 3 · Interventional · 123 enrolled · GlaxoSmithKline
  NCT05334368updated 2025-11-25
• eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
  Recruiting · Phase 3 · Interventional · 1,196 enrolled · GlaxoSmithKline
  NCT07177339updated 2025-11-25
• Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
  Active not recruiting · Phase 3 · Interventional · 163 enrolled · GlaxoSmithKline
  NCT05263934updated 2025-11-20

Frequently asked questions

How does Depemokimab work?

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.

What is Depemokimab used for?

According to FDA labeling, Depemokimab carries indications including: 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 ( 5.2 )] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Depemokimab?

Depemokimab is classified as Other systemic drugs for obstructive airway diseases, Interleukin-5 Antagonists.

What are the brand names for Depemokimab?

Depemokimab is marketed under brand names including Exdensur.

What are the contraindications for Depemokimab?

Depemokimab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.