Prolia®

DRUG13 trials

Sponsors

Shanghai Biomabs Pharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Teva Pharmaceuticals USA, Mabwell (Shanghai) Bioscience Co., Ltd., Gedeon Richter Plc.

Conditions

Glucocorticoid-induced OsteoporosisHealthy PeopleHealthy VolunteersOsteoporosisOsteoporosis, PostmenopausalPostmenopausalPostmenopausal OsteoporosisPostmenopausal Women Osteoporosis

Phase 1

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

CompletedNCT03925051

Shanghai Biomabs Pharmaceutical Co., Ltd.Postmenopausal Osteoporosis

Start: 2019-07-01End: 2020-06-18Updated: 2020-10-14

Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults

Qilu Pharmaceutical Co., Ltd.Healthy People

Start: 2019-10-31End: 2020-10-31Target: 144Updated: 2019-12-30

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults

CompletedNCT04798313

Mabwell (Shanghai) Bioscience Co., Ltd.Osteoporosis, Postmenopausal

Start: 2020-06-02End: 2020-12-31Updated: 2021-03-15

Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS

CompletedNCT05323708

Biocon Biologics UK LtdHealthy Volunteers

Start: 2022-03-09End: 2023-10-06Updated: 2024-04-17

Phase 3

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

CompletedNCT04591275

Shanghai Biomabs Pharmaceutical Co., Ltd.Postmenopausal Osteoporosis

Start: 2021-03-31End: 2024-11-01Updated: 2025-02-20

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

CompletedNCT04729621

Teva Pharmaceuticals USAOsteoporosis, Postmenopausal

Start: 2021-03-22End: 2023-06-19Updated: 2024-04-18

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

CompletedNCT05087030

Gedeon Richter Plc.Postmenopausal Osteoporosis

Start: 2021-09-21End: 2023-11-15Updated: 2024-10-24

Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis

CompletedNCT05345691

Biocon Biologics UK LtdPostmenopausal Women With Osteoporosis

Start: 2022-05-24End: 2024-06-12Updated: 2025-09-09

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

CompletedNCT05352516

Shanghai Henlius BiotechPostmenopausal

Start: 2022-06-17End: 2024-07-03Updated: 2024-09-20

Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

WithdrawnNCT06504966

Xentria, Inc.Osteoporosis

Start: 2025-10-31End: 2027-10-31Updated: 2025-05-11

A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis

RecruitingNCT06804590

Mabwell (Shanghai) Bioscience Co., Ltd.Postmenopausal Women Osteoporosis

Start: 2024-11-16End: 2026-07-30Target: 278Updated: 2025-02-03

A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®

RecruitingNCT07062978

Qilu Pharmaceutical Co., Ltd.Postmenopausal Women With Osteoporosis at High Risk of Fracture

Start: 2025-06-27End: 2027-01-31Target: 278Updated: 2025-07-14

Phase 4

A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China

RecruitingNCT06588153

AmgenGlucocorticoid-induced Osteoporosis

Start: 2025-05-24End: 2027-05-24Target: 100Updated: 2026-03-25

Related Papers

A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis.

2025-10-14

Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial

Expert Opinion on Biological Therapy2023-03-097 citations

Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects

Frontiers in Pharmacology2022-01-249 citations