Prolia
(Denosumab)ApprovedMonoclonal antibody
AmgenDenosumab is used to treat bone loss and prevent fractures in people with osteoporosis, and it's also used to prevent bone damage in patients with certain cancers.[2] Prolia is currently approved and in use across 65 indications[4].[1]
Prolia is one of 1216 small molecule programs targeting Arthropathy. It is currently in Approved.
65
Indications
183
Total Trials
32
Active Trials
1,215
Competitors
5
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 65 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Prolia
AmgenApproved
Trodelvy
GileadPreclinical
Halaven
EisaiPreclinical
Adriamycin
GGynecologic Oncology Group
Preclinical
DATROWAY
Daiichi SankyoPreclinical
Zinecard
CChildren's Oncology Group
Preclinical
Spravato
WWim Janssens
Preclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Apatinib Mesylate
BBukwang Pharmaceutical
Preclinical
Fentanyl Citrate
IINSYS Therapeutics Inc
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q3 2026
Post-ApprovalRecruiting
Postmenopausal Osteoporosis
NCT07283887
Phase 1/2Active, not recruiting
Azoospermia
NCT06706414
Phase 2Active, not recruiting
Breast
NCT04067726
Post-ApprovalActive, not recruiting
Alcoholic Fatty Liver Disease
NCT05493761
Post-ApprovalActive, not recruiting
Osteoporosis
NCT05666310
N/ARecruiting
Prevention
NCT05866029
Clinical
Trials by Indication[1]
Osteoporosis22 trials
Show 19 more trials
Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study
Completed·—·Phase 2·NCT02632916·10 enrolled
Breast Cancer14 trials
Show 11 more trials
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer
Terminated·—·Phase 2·NCT01545648·4 enrolled
Giant Cell Tumor7 trials
Show 4 more trials
Bone6 trials
RA Denosumab on Bone Microstructure Study
Completed·—·Phase 4·NCT01770106·40 enrolled
Show 3 more trials
Low Bone Mineral Density5 trials
88 more indications
Postmenopausal Osteoporosis5 trials
Postmenopausal Women5 trials
Show 2 more trials
Multiple Myeloma5 trials
Treatment4 trials
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Active, not recruiting·JJames J. Peters Veterans Affairs Medical Center·Phase 4·NCT05101018·40 enrolled
Sequential Therapies After Osteoanabolic Treatment
Recruiting·—··NCT06164795·150 enrolled
Show 1 more trial
Denosumab Treatment in CKD Patients at High Risk of Fracture
Unknown status·—·N/A·NCT05692297·102 enrolled
Bone Metastasis3 trials
Spinal Cord Injury2 trials
Biomarkers2 trials
Osteogenesis Imperfecta2 trials
Fibrous Dysplasia2 trials
Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia
Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT05419050·15 enrolled
Denosumab Treatment for Fibrous Dysplasia
Active, not recruiting·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT03571191·9 enrolled
Total Hip Arthroplasty2 trials
Metastatic Prostate Cancer2 trials
Non-Small Cell Lung Cancer2 trials
Vertebroplasty2 trials
Prevention2 trials
Osteoarthritis2 trials
Immunogenicity2 trials
Male Infertility2 trials
Chronic Kidney Disease2 trials
Rheumatoid Arthritis2 trials
Prostate Cancer2 trials
Urothelial Cancer1 trial
Observational Study1 trial
Bone Metastases1 trial
Lumbar Fusion Surgery1 trial
Healing1 trial
Effect of Denosumab in Erosion Healing in RA
Completed·—·Phase 2·NCT03239080·110 enrolled
Menopausal Women1 trial
Advanced Solid Tumours1 trial
Stem Cell Transplant1 trial
Type 1 Diabetes1 trial
Denosumab for Type 1 Diabetes
Recruiting·—·Phase 1/2·NCT06524960·45 enrolled
BRCA1/2 Mutation1 trial
Hypercalcemia1 trial
Kidney Cancer1 trial
Relapsed or Refractory1 trial
Advanced NSCLC1 trial
Idiopathic Inflammatory Myopathies1 trial
Unresectable1 trial
Reduced Dose-density of Denosumab for Unresectable GCTB
Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03620149·2 enrolled
Liver Transplant1 trial
Bone Resorption1 trial
Trial1 trial
Anorexia Nervosa1 trial
Efficacy and Safety1 trial
Total Knee Arthroplasty1 trial
Safety and Efficacy1 trial
Concentration1 trial
Metabolism1 trial
Circulating Myokine Levels and Bone Metabolism
Completed·—··NCT04206618·220 enrolled
Metastatic Melanoma1 trial
Alcoholic Fatty Liver Disease1 trial
Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease
Active, not recruiting·—·Phase 4·NCT05493761·72 enrolled
Primary Hyperparathyroidism1 trial
Denosumab in Primary Hyperparathyroidism
Terminated·—·Phase 4·NCT01558115·8 enrolled
Arthropathy1 trial
Colorectal Cancer1 trial
Systemic Mastocytosis1 trial
Bone Marrow Transplantation1 trial
Aortic Stenosis1 trial
Metastatic Solid Tumors1 trial
Insulin Sensitivity1 trial
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
Recruiting·—·Phase 4·NCT07271771·40 enrolled
Children1 trial
Unspecified9 trials
Show 6 more trials
Effects of Denosumab Therapy for Japanese
Unknown status·—··NCT02491515·500 enrolled
Regulatory
FDA Approval Timeline[5]
Jun 1, 2010
PROLIA
BLA BLA125320
Mar 5, 2024
WYOST
BLA BLA761362
Feb 13, 2025
OSPOMYV
BLA BLA761392
Mar 25, 2025
CONEXXENCE
BLA BLA761398
Aug 29, 2025
BILPREVDA
BLA BLA761444
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Prolia drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Denosumab. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]