Depemokimab Regulatory review Naked monospecific

Antibody Information

Entry ID	683
INN	Depemokimab
Status	Regulatory review
Drug code(s)	GSK3511294
Brand name	(Pending)
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-5
Indications of clinical studies	Hypereosinophilic Syndrome, Nasal Polyps, Eosinophilic Granulomatosis With Polyangiitis, Mild to Moderate Asthma
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Regulatory review EU, US, Japan, China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 17, 2017
Start of Phase 2
Start of Phase 3	January 26, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	GSK
Licensee/Partner	None
Comments about company or candidate	The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025. Jan 28, 2025: GSK plc announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications. The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). GSK plc also announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications. In China, the submitted indications are for an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 and older with type 2 inflammation characterised by blood eosinophil count, and add-on maintenance treatment of adult patients with inadequately controlled CRSwNP. In Japan, the submitted indications are for treatment of severe or refractory bronchial asthma and CRSwNP inadequately controlled with standard treatment. EMA started evaluation on Jan 23, 2025. NDA submitted in China, most likely in Dec 2024. https://www.echemi.com/cms/2194899.html Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); are recruiting as of September 2024. Phase 3 studies in Nasal polyps (NCT05274750, NCT05281523) have been completed; Phase 3 studies in severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680 and NCT04718389) are active non recruiting as of Spetember-October 2024, while NCT04719832 and NCT04718103 studies have been completed. May 2024: Positive results from SWIFT 1 and 2 announced https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-severe-asthma-trials-of-depemokimab/ Phase 3 studies for Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); Nasal polyps (NCT05274750, NCT05281523); Severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680, NCT04719832, NCT04718103, NCT04718389) are all recruiting as of Jan-May 2023 except NCT04719832 and NCT04718103 for asthma which are active not recruiting as of Feb-May 2023. Two Phase 3 studies in nasal polyps started in Mar 2022. Three Phase 3 studies started in Jan 2021 (NCT04718389, NCT04718103, NCT04719832). Listed as Phase 1 in GSK pipeline accessed Aug 12, 2019. FIH Phase 1 NCT03287310 study still recruiting as of Aug 2018. GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating population of eosinophils.
Full address of company	980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/

Description/comment

GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5

Additional information

Anticipated events	Regulatory decision in US Dec 16, 2025
Factor(s) contributing to discontinuation	None