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Drug

Depemokimab

Approved · FDA / EMA
Late-stage development

Also known as Exdensur.

RxNorm2729265UNIID16EQP0KKH
8
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy

Clinical trial2026-07-08Results expected Q3 2026 · ClinicalTrials.gov

The IMAGINE Study: A Phase 3b Open Label, Single Arm Study to Assess the Effect of Depemokimab on Airway Structure and Function in Asthma With Type 2 Inflammation Characterized by an Eosinophilic Phenotype Utilizing Quantitative High-resolution CT and Bronchoscopic Airway Sampling in a Sub Study

Clinical trial2026-07-02Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old

Clinical trial2026-06-26Results expected Q1 2029 · ClinicalTrials.gov

The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks

Clinical trial2026-06-25Results expected Q3 2030 · ClinicalTrials.gov

An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants

Clinical trial2026-06-16Results posted · ClinicalTrials.gov

Label change: DEPEMOKIMAB (BLA761458)

Regulatory2026-06-10FDA

An Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Dose Levels of GSK3511294 Administered Subcutaneously in Chinese Healthy Participants

Clinical trial2026-05-26Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation

Clinical trial2026-04-09Results expected Q3 2029 · ClinicalTrials.gov

Approval: Exdensur (EMA)

Regulatory2026-02-12EMA

Approval: DEPEMOKIMAB (BLA761458)

Regulatory2025-12-16FDA

A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

Clinical trial2025-12-03Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

Clinical trial2025-11-25Results expected Q4 2029 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Depemokimab
Aliases & brands
Exdensur
RxNorm CUI
2729265
UNII
D16EQP0KKH
Regulatory jurisdictions
emafda

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2025-12-16 → 2026-02-12)
Earliest approval
2025-12-16
Latest approval
2026-02-12
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-10Label change
Label change: DEPEMOKIMAB (BLA761458)
Evidence ↗
2025-12-16ApprovalMulti-authority
Approval: DEPEMOKIMAB (BLA761458)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2026-02-12ApprovalMulti-authority
Approval: Exdensur (EMA)
Indication: Asthma  Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12… Show full indication

Asthma  Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP)  Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2024
8
Active studies
7
Recruiting
10
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 12
Phase 12Phase 310

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks

RecruitingPH IIIGlaxoSmithKlinen=4562030

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation

RecruitingPH IIIKey trialGlaxoSmithKlinen=1,1962029

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab in Adult Participants With COPD With Type 2 Inflammation

RecruitingPH IIIGlaxoSmithKlinen=9602029

A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation

RecruitingPH IIIGlaxoSmithKlinen=9812029

A Phase 3, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Depemokimab (GSK3511294) Administered Subcutaneously as Add on Maintenance Treatment of Asthma With Type 2 Inflammation Characterised by an Eosinophilic Phenotype in Participants Aged 6 to 11 Years Old

Not yet recruitingPH IIIGlaxoSmithKlinen=302029

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

CompletedPH IIIGlaxoSmithKlinen=2762024

A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-2 (depemokimAb iN CHrOnic Rhinosinusitis)

CompletedPH IIIGlaxoSmithKlinen=2642024

An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants

CompletedPH IGlaxoSmithKlinen=1402023

An Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Dose Levels of GSK3511294 Administered Subcutaneously in Chinese Healthy Participants

CompletedPH IGlaxoSmithKlinen=202022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.