Product
Prolia
Aliases
Denosumab, US-licensed Prolia
7 clinical trials
5 indications
Indication
OsteoporosisIndication
Postmenopausal Women With OsteoporosisIndication
Healthy Control ParticipantsIndication
Healthy SubjectIndication
Healthy Male ParticipantsClinical trial
A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland ChinaStatus: Not yet recruiting, Estimated PCD: 2026-07-29
Clinical trial
A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With OsteoporosisStatus: Completed, Estimated PCD: 2023-05-18
Clinical trial
A Randomized, Double-blind, Parallel Controlled, Phase I Study, Comparing the PK, PD, Safety, and Immunogenicity of Post-change CMAB807and Prolia in Healthy Chinese SubjectsStatus: Recruiting, Estimated PCD: 2024-05-30
Clinical trial
A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male SubjectsStatus: Completed, Estimated PCD: 2022-10-20
Clinical trial
A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia®, and US-sourced Prolia®) in Healthy Adult Male VolunteersStatus: Recruiting, Estimated PCD: 2024-05-01
Clinical trial
A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)Status: Completed, Estimated PCD: 2023-08-07
Clinical trial
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With OsteoporosisStatus: Completed, Estimated PCD: 2022-06-20