HLX14 (denosumab biosimilar) / Fosun Pharma, Organon 
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3 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
HLX14 (denosumab biosimilar) / Fosun Pharma, Organon
2022-002188-31: A randomized, double-blind, international multicenter, parallel-controlled phase III clinical study to compare the efficacy, safety, tolerability and immunogenicity of HLX14 vs. Denosumab Injection (Prolia®) in postmenopausal women with osteoporosis at high risk of fracture

Not yet recruiting
3
478
Europe
Recombinant Anti-RANKL Human Monoclonal Antibody, Prolia, HLX14, Solution for injection, Prolia
Shanghai Henlius Biotech, Inc., Shanghai Henlius Biotech, Inc.
Osteoporosis at High Risk of Fracture, Osteoporosis at High Risk of Fracture, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT05352516 / 2022-002188-31: A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Completed
3
514
RoW
HLX14, Prolia®
Shanghai Henlius Biotech, Shanghai Henlius Biotech, Inc.
Postmenopausal
12/23
07/24
NCT04534582: Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

Completed
1
252
RoW
HLX14, EU-Prolia®, US-Prolia®, CN-Prolia®
Shanghai Henlius Biotech
Healthy Male Volunteers
09/23
09/23
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
HLX14 (denosumab biosimilar) / Fosun Pharma, Organon
2022-002188-31: A randomized, double-blind, international multicenter, parallel-controlled phase III clinical study to compare the efficacy, safety, tolerability and immunogenicity of HLX14 vs. Denosumab Injection (Prolia®) in postmenopausal women with osteoporosis at high risk of fracture

Not yet recruiting
3
478
Europe
Recombinant Anti-RANKL Human Monoclonal Antibody, Prolia, HLX14, Solution for injection, Prolia
Shanghai Henlius Biotech, Inc., Shanghai Henlius Biotech, Inc.
Osteoporosis at High Risk of Fracture, Osteoporosis at High Risk of Fracture, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT05352516 / 2022-002188-31: A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Completed
3
514
RoW
HLX14, Prolia®
Shanghai Henlius Biotech, Shanghai Henlius Biotech, Inc.
Postmenopausal
12/23
07/24
NCT04534582: Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects

Completed
1
252
RoW
HLX14, EU-Prolia®, US-Prolia®, CN-Prolia®
Shanghai Henlius Biotech
Healthy Male Volunteers
09/23
09/23

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