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Depemokimab

Phase 3

Asthma | Monoclonal antibody | Respiratory |GSK plc|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment766
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07456033A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 AsthmaPHASE3 NOT YET_RECRUITING 456 — — Mar 6, 2026Jul 1, 2030Mar 6, 2026 - —
NCT06979323Depemokimab Asthma Imaging and Bronchoscopy Sub-StudyPHASE3 RECRUITING 150 — — Jun 3, 2025Feb 11, 2028Apr 23, 202643 United States, Belgium +9
NCT05602025A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult ParticipantsPHASE1 COMPLETED 140 — — Dec 13, 2022Oct 23, 2023Jun 17, 20243 United States
NCT05140200Study of GSK3511294 in Healthy Chinese ParticipantsPHASE1 COMPLETED 20 — — Dec 10, 2021Dec 23, 2022May 26, 20261 China
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Study Endpoints
Primary Endpoints
Annualized rate of clinically significant exacerbations
Up to Week 156

A clinically significant exacerbation is defined as a worsening of asthma requiring the use of systemic corticosteroids.

Mean Change from Baseline in Total Mucus Plug Volume Measured at Total Lung Capacity (TLC) at Week 26
From Baseline up to Week 26

Mean change from baseline in total mucus plug volume measured at TLC at Week 26 will be assessed.

Maximum observed plasma concentration (Cmax) of depemokimab
Up to Week 26
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab
Up to Week 26
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab
Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab
Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-T). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 4). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 4 post-dose correlates to Day 1 plus 28 days, that is, Day 29.

AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab
Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, that is, Day 85.

AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 26). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for percentage of AUC(0-Infinity) obtained by extrapolation. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Time of Occurrence of Cmax (Tmax) Of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. Tmax was determined directly from the plasma concentration-time data. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Time To Last Quantifiable Concentration (Tlast) of Depemokimab
Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Apparent Clearance (CL/F) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for Apparent Clearance. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Apparent Volume of Distribution (Vz/F) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for apparent volume of distribution. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Terminal Elimination Rate Constant (Lambda Z) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for Terminal elimination rate constant. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Terminal Phase Half-Life (T1/2) of Depemokimab
Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Blood samples were collected from participants at indicated time points and analyzed for Terminal phase half-life. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183.

Secondary Endpoints
Proportion of participants with clinical remission at 2 years
At 2 years
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total overall score at 2 years
Baseline and at 2 years
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at 2 years
Baseline and at 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DepemokimabEXPERIMENTALParticipants will be administered depemokimab along with standard of care (SoC).
PlaceboPLACEBO_COMPARATORParticipants will be administered placebo along with SoC
Participants receiving depemokimab via a SSDEXPERIMENTAL -
Participants receiving depemokimab via an autoinjectorEXPERIMENTAL -
Depemokimab 100mgEXPERIMENTALHealthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
Depemokimab 300mgEXPERIMENTALHealthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.
Interventions
NameTypeDescription
DepemokimabDRUGDepemokimab will be administered
PlaceboDRUGPlacebo will be administered
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adults and adolescents \>=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \>=18 years of age. * Participants ...

Countries:United StatesBelgiumCanadaChinaFranceGermanyGreeceItalySpainTaiwanUnited Kingdom
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Competitive Landscape -Asthma 81 trials
CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Run-In Medication, QMF149, Budesonide
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS, Budesonide/Formoterol, TEV-56248, Albuterol
GSK plc Sponsored ADRGSK6PHASE3Depemokimab, FF/UMEC/VI, GSK5784283, Salbutamol HFA-152a, Salbutamol HFA-134a
Sanofi SA Sponsored ADRSNY8PHASE3Dupilumab, Dupilumab Prefilled Syringe, Amlitelimab, Lunsekimig, Short-Acting Beta Agonists
AstraZeneca PLCAZN29PHASE3Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, Mannitol
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Amgen Inc.AMGN2PHASE2Rocatinlimab, AMG 691
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Upstream Bio, Inc.UPB1PHASE2Verekitug
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
Unity Health TorontoUBX1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06979323primaryCompletionDate: changed
LOWMay 26, 2026NCT07456033primaryCompletionDate: changed
LOWMay 24, 2026NCT06979323studyFirstPostDate: changed
LOWMay 24, 2026NCT07456033studyFirstPostDate: changed