Prolia

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

36 competitors in Osteoporosis

#DrugCompanyPhaseTrials

1

Forteo

AAlmaject

Approved

392

Zometa

Pfizer

Approved

153

Fosamax

OOrganon and Co

Approved

324

Evista

Eli Lilly

Approved

75

Rocaltrol

Jazz Pharmaceuticals

Approved

36

Estrace

Novo Nordisk

Approved

17

Sensipar

Amgen

Approved

—8

Calciferol

Jazz Pharmaceuticals

Approved

—9

Achromycin V

WWyeth-Lederle Vaccines

Approved

110

Epsom Salt

FFresenius Kabi USA, LLC

Approved

—Show 19 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Osteoporosis5 trials

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

Completed·BBiocon Biologics UK PLC·Phase 3·NCT05345691·479 enrolled

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

Completed·Shanghai Henlius Biotech·Phase 3·NCT05352516·514 enrolled

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Completed·SSamsung Bioepis Co., Ltd.·Phase 3·NCT04664959·457 enrolled

Show 2 more trials

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

Recruiting·Amgen·Phase 4·NCT06588153·100 enrolled

Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China

Active, not recruiting·Amgen·Phase 4·NCT06332014·102 enrolled

Immunogenicity4 trials

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

Withdrawn·XXentria, Inc.·Phase 3·NCT06504966

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

Completed·MMabwell (Shanghai) Bioscience Co., Ltd.·Phase 1·NCT04798313·120 enrolled

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Unknown status·SShanghai Hansoh Biomedical Co., Ltd·Phase 1·NCT04940845·174 enrolled

Show 1 more trial

Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

Unknown status·KKunming Pharmaceuticals, Inc.·Phase 1·NCT04673799·144 enrolled

Adult2 trials

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

Unknown status·Qilu Pharmaceutical Co., Ltd.·Phase 1·NCT04213105·144 enrolled

A Study to Evaluate LY06006 and Prolia in Healthy Adults

Unknown status·Luye Pharma Group Ltd.·Phase 1·NCT04973722·168 enrolled

Phase 11 trial

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

Completed·SShanghai Biomabs Pharmaceutical Co., Ltd.·Phase 1·NCT03925051·132 enrolled

Clinical Efficacy and Safety1 trial

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

Completed·SShanghai Biomabs Pharmaceutical Co., Ltd.·Phase 3·NCT04591275·278 enrolled

6 more indications

Postmenopausal Osteoporosis1 trial

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

Completed·GGedeon Richter Plc.·Phase 3·NCT05087030·473 enrolled

MPA1 trial

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Completed·EEnzene Biosciences Ltd.·Phase 3·NCT05405725·504 enrolled

Trial1 trial

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

Completed·BBiocon Biologics UK PLC·Phase 1·NCT05323708·190 enrolled

Efficacy and Safety1 trial

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

Recruiting·Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT07062978·278 enrolled

Postmenopausal Women1 trial

A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis

Completed·MMabwell (Shanghai) Bioscience Co., Ltd.·Phase 3·NCT06804590·280 enrolled

Unspecified2 trials

AVT03 With Prolia in Healthy Male Subjects

Completed·AAlvotech Swiss AG·Phase 1·NCT05126784·209 enrolled

Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT06361355·128 enrolled

Details

Drug Info

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