DENOSUMAB-DSSB

GrowthmAb

denosumab

Samsung Bioepis
BLASUBCUTANEOUSINJECTABLE
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

RANK Ligand Blocking Activity

Pharmacologic Class:

RANK Ligand Inhibitor

Indications (9)

postmenopausal women with osteoporosis at high risk for fracturedefinedmultiple risk factors for fractureglucocorticoid-induced osteoporosis in menwomen at high risk of fracturecontinuing systemic glucocorticoids in a daily dosage equivalent to 7osteoporosisprostate cancerbreast cancer

Clinical Trials (5)

NCT05884372Phase 4Completed

Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)

Started Aug 2023
100 enrolled
Osteoporosis in Postmenopausal Women
NCT04586660Phase 4Active Not Recruiting

Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

Started Aug 2023
36 enrolled
Giant Cell Tumor of Bone
NCT04711109Phase 3Active Not Recruiting

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

Started Feb 2023
300 enrolled
BRCA1 MutationBreast CancerBreast Diseases+3 more
NCT05405725Phase 3Completed

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Started Jul 2022
504 enrolled
Postmenopausal Osteoporosis
NCT05245669Phase 1Completed

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Started Jan 2022
207 enrolled
Healthy Male Subjects
Company
Samsung Bioepis
Samsung Bioepis
Korea - Incheon
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers