Prolia

Phase 3Small molecule

Qilu Pharmaceutical Co., Ltd.

Prolia is one of 62 small molecule programs targeting Postmenopausal Osteoporosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Postmenopausal OsteoporosisActive, not recruiting

OsteoporosisActive, not recruiting

Postmenopausal OsteoporosisPhase 3

Active, not recruiting

OsteoporosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

172 competitors in Osteoporosis

#DrugCompanyPhaseTrials

Boniva

CConrado Roberto Hoffmann Filho

Phase 3

26 2

Actonel

VVitae Pharmaceuticals Inc., an Allergan affiliate

Phase 3

16 3

One-Alpha

Roche

Phase 3

3 4

Livial

Pfizer

Phase 3

1 5

Depo-Provera

Tymlos

2 7

Glucophage

EMD Serono

Phase 3

1 8

Oxycodone IR

Johnson & Johnson

Phase 3

1 9

Bazedoxifene Acetate

Pfizer

Phase 3

2 10

Ibandronic Acid

Roche

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Osteoporosis

NCT06804590

Q1 2027

Phase 3Recruiting

Efficacy and Safety

NCT07062978

Post-ApprovalActive, not recruiting

Osteoporosis

NCT06332014

Q2 2027

Post-ApprovalRecruiting

Osteoporosis

NCT06588153

Clinical

Trials by Indication[1]

Osteoporosis6 trials

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

Active, not recruiting· Amgen logo

Amgen·Phase 4·NCT06332014·102 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

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

Show 3 more trials

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

Recruiting·MMabwell (Shanghai) Bioscience Co., Ltd.·Phase 3·NCT06804590·278 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 logo

Shanghai Henlius Biotech·Phase 3·NCT05352516·514 enrolled

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

Recruiting· Amgen logo

Amgen·Phase 4·NCT06588153·100 enrolled

Immunogenicity4 trials

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

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

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

Withdrawn·XXentria, Inc.·Phase 3·NCT06504966

Show 1 more trial

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

Adult2 trials

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

Unknown status· Qilu Pharmaceutical Co., Ltd. logo

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. logo

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

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

Efficacy and Safety1 trial

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

Recruiting· Qilu Pharmaceutical Co., Ltd. logo

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

5 more indications

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

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

MPA1 trial

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

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

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Prolia. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Prolia compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Prolia. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Qilu Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Qilu Pharmaceutical Co., Ltd.

Prolia

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Osteoporosis6 trials

Immunogenicity4 trials

Adult2 trials

Postmenopausal Osteoporosis1 trial

Efficacy and Safety1 trial

Phase 11 trial

Clinical Efficacy and Safety1 trial

Trial1 trial

MPA1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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