Depemokimab History and Updates

48 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Depemokimab since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (8)

2026

Results postedDepemokimab Phase 1 PK Study in Healthy Chinese Participants Shows…· May 26, 2026
Results postedDepemokimab Phase 3 for Severe Asthma Misses Non-Inferiority Endpoint· May 18, 2026
Results postedDepemokimab Phase 3 Extension Study Characterizes Long-Term Asthma Safety· Jan 15, 2026

2025

FDA approvalExdensur (depemokimab) Receives Initial FDA Approval as New Molecular Entity· Dec 16, 2025
Results postedDepemokimab Phase 3 Trial Reduces Nasal Polyp Score in CRSwNP· Dec 3, 2025
Primary completionDepemokimab Phase 3 Trial for Severe Eosinophilic Asthma Completes Primary Study· Sep 14, 2025
Results postedDepemokimab Shows Significant Improvement in Nasal Polyps and Symptoms in CRSwNP· Sep 9, 2025
Primary completionDepemokimab Phase 3 Extension Study for Asthma Posts Long-Term Safety Data· May 19, 2025

Upcoming & expected milestones

Primary completionSep 29, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05263934

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyang

Primary completionDec 8, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06979323

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

Primary completionDec 19, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05334368

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Primary completionAug 20, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06959095

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

Primary completionAug 21, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06961214

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

Primary completionNov 2, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Infl

Primary completionJul 1, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07456033

A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

Past events

2026

Results postedJun 16, 2026· ClinicalTrials.gov

Trial results posted: NCT05602025

A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy

Results postedMay 26, 2026· ClinicalTrials.gov

Trial results posted: NCT05140200

Study of GSK3511294 in Healthy Chinese Participants

Results postedMay 18, 2026· ClinicalTrials.gov

Trial results posted: NCT04718389

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenot

Trial registeredMar 6, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07456033

A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

Trial startedMar 6, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07456033

A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

Results postedJan 15, 2026· ClinicalTrials.gov

Trial results posted: NCT05243680

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NC

2025

FDA approvalDec 16, 2025· FDA

FDA approved Exdensur (depemokimab) (BLA 761458)

Sponsor: GLAXOSMITHKLINE LLC. Class: Type 1 - New Molecular Entity.

Results postedDec 3, 2025· ClinicalTrials.gov

Trial results posted: NCT05274750

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Trial startedOct 20, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Infl

Trial registeredSep 17, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07177339

eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Infl

Primary completionSep 14, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04718389

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenot

Results postedSep 9, 2025· ClinicalTrials.gov

Trial results posted: NCT05281523

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Trial startedJun 23, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06961214

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

Trial startedJun 20, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06959095

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

Trial startedJun 3, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06979323

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

Primary completionMay 19, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05243680

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NC

Trial registeredMay 18, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06979323

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study

Trial registeredMay 7, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06961214

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

Trial registeredMay 6, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06959095

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (

2024

Results postedDec 17, 2024· ClinicalTrials.gov

Trial results posted: NCT04719832

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Primary completionJul 30, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05274750

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Primary completionJul 12, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05281523

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

2023

Primary completionNov 21, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04719832

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Primary completionOct 23, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05602025

A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy

2022

Primary completionDec 23, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05140200

Study of GSK3511294 in Healthy Chinese Participants

Trial startedDec 13, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05602025

A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy

Trial registeredNov 1, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05602025

A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy

Trial startedSep 6, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05334368

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Trial startedJul 14, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05263934

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyang

Trial startedApr 22, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05274750

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Trial registeredApr 19, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05334368

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

Trial startedApr 18, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05281523

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Trial registeredMar 16, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05281523

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Trial registeredMar 10, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05274750

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Trial registeredMar 3, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05263934

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyang

Trial startedMar 1, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05243680

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NC

Trial registeredFeb 17, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05243680

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NC

2021

Trial startedMar 17, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04719832

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Trial startedJan 26, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04718389

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenot

Trial registeredJan 22, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04718389

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenot

Trial registeredJan 22, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04719832

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.