Prolia

(Denosumab)

ApprovedMonoclonal antibody

Denosumab 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 28 indications[4].[1]

Prolia is one of 552 small molecule programs targeting Fibrous Dysplasia. It is currently in Approved.

Indications

186

Total Trials

Active Trials

551

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Fibrous DysplasiaActive, not recruiting

Breast CancerActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

Total Knee ArthroplastyActive, not recruiting

Bone NeoplasmUnknown

Bone ResorptionUnknown

Bone Giant Cell TumorUnknown

Osteoarthritis, KneeActive, not recruiting

MetastasisUnknown

Bone Resorption DiseaseUnknown

Fibrous DysplasiaPhase 2

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Alcoholic Fatty Liver DiseaseApproved

Active, not recruiting

Total Knee ArthroplastyApproved

Active, not recruiting

Bone NeoplasmPreclinical

Unknown

Bone ResorptionPreclinical

Unknown

Bone Giant Cell TumorPreclinical

Unknown

Osteoarthritis, KneePreclinical

Active, not recruiting

MetastasisPreclinical

Unknown

Bone Resorption DiseasePreclinical

Unknown

Showing 10 of 28 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Prolia

OOrganon and Co

Approved

14 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Ablavar

LLantheus Medical Imaging

Preclinical

2 6

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 7

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

1 8

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 10

Ibrance

Pfizer

Preclinical

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

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

Prevention

NCT05866029

Q4 2026

Phase 3Recruiting

Trial

NCT04547348

Post-ApprovalActive, not recruiting

Study completion

NCT04467983

Post-ApprovalNot yet recruiting

Postmenopausal Osteoporosis

NCT06720350

Q1 2027

Phase 2Active, not recruiting

Chronic

NCT04232657

Post-ApprovalRecruiting

Insulin Sensitivity

NCT07271771

Clinical

Trials by Indication[1]

Osteoporosis21 trials

Muscle Impact of Treating Osteoporosis

Active, not recruiting·NNami Safai Haeri·Phase 4·NCT05666310·20 enrolled

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

Unknown status·YYonsei University·Phase 4·NCT06272227·340 enrolled

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Completed·AAlvotech Swiss AG·Phase 3·NCT05395091·532 enrolled

Show 18 more trials

Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT00523341·4,550 enrolled

Preventing Osteoporosis Using Denosumab

Completed·SSusan L. Greenspan·Phase 4·NCT02753283·201 enrolled

Unknown status·LLambda Therapeutic Research Ltd.·Phase 3·NCT05419427·552 enrolled

Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00680953·1,262 enrolled

A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

Completed· GSK logo

GSK·Phase 3·NCT01457950·135 enrolled

Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis

Completed·EErsi Voskaridou·Phase 2·NCT02559648·63 enrolled

Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)

Completed·XXi'an Honghui Hospital·Phase 4·NCT05884372·100 enrolled

Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Completed·TTuen Mun Hospital·Phase 4·NCT01465568·40 enrolled

Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT03164928·24 enrolled

Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

Completed·RRudolf Wuethrich·Phase 3·NCT01377467·90 enrolled

Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT00980174·242 enrolled

Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 3·NCT06154707·86 enrolled

A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

Completed· GSK logo

GSK·Phase 3·NCT01495000·250 enrolled

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT01575834·7,180 enrolled

Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis

Unknown status·SShanghai JMT-Bio Inc.·Phase 2·NCT05278338·200 enrolled

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01753856·69 enrolled

Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study

Completed·—·Phase 2·NCT02632916·10 enrolled

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 4·NCT01732770·643 enrolled

Breast Cancer14 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

Denosumab for Breast Cancer With Bone Mets

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01952054·7 enrolled

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

Terminated·JJules Bordet Institute·Phase 2·NCT01864798·27 enrolled

Show 11 more trials

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT04711109·300 enrolled

Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells

Terminated·NNorthwestern University·Phase 2·NCT03070002·1 enrolled

Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Completed· Amgen logo

Amgen·Phase 2·NCT00091832·255 enrolled

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

Terminated· Amgen logo

Amgen·Phase 3·NCT01077154·4,509 enrolled

Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer

Unknown status·IInstitut Català d'Oncologia·Phase 1·NCT03691311·60 enrolled

Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer

Withdrawn·BBorstkanker Onderzoek Groep·Phase 2·NCT03532087

Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer

Active, not recruiting·KKyoto Prefectural University of Medicine·Phase 3·NCT03324932·160 enrolled

Presurgical Trial of Denosumab in Breast Cancer

Completed·NNYU Langone Health·Phase 1·NCT02900469·44 enrolled

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.

Completed· Amgen logo

Amgen·Phase 3·NCT00321464·2,049 enrolled

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

Completed· Amgen logo

Amgen·Phase 3·NCT00556374·3,420 enrolled

Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02366130·45 enrolled

Giant Cell Tumor7 trials

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone

Completed· Amgen logo

Amgen·Phase 2·NCT00396279·37 enrolled

A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone

Completed·SShanghai JMT-Bio Inc.··NCT05402865·301 enrolled

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

Not yet recruiting·SShanghai JMT-Bio Inc.·Phase 3·NCT05813665·146 enrolled

Show 4 more trials

Characteristics and Mechanism of Denosumab-treated Giant Cell Tumor of Bone

Unknown status·HHebei Medical University Third Hospital·Phase 3·NCT03259152·30 enrolled

Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China

Unknown status·PPeking University People's Hospital··NCT03358212·100 enrolled

Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Completed· Amgen logo

Amgen·Phase 2·NCT00680992·535 enrolled

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Completed· Amgen logo

Amgen·Phase 4·NCT03301857·85 enrolled

Bone6 trials

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

Completed·—·Phase 4·NCT02499237·57 enrolled

Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02903446·20 enrolled

RA Denosumab on Bone Microstructure Study

Completed·—·Phase 4·NCT01770106·40 enrolled

Show 3 more trials

Osteoclast Inhibition and Bone Formation

Completed·MMayo Clinic·Phase 1·NCT02554695·81 enrolled

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Completed·MMassachusetts General Hospital·Phase 4·NCT04026256·37 enrolled

Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

Completed·HHealthEast Care System··NCT02435147·86 enrolled

Postmenopausal Osteoporosis6 trials

Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Completed·MMassachusetts General Hospital·Phase 2·NCT00926380·94 enrolled

Anabolic Therapy in Postmenopausal Osteoporosis

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT05010590·50 enrolled

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT00089791·7,808 enrolled

Show 3 more trials

Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures

Not yet recruiting·MMarmara University·Phase 4·NCT06720350·60 enrolled

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

Recruiting·NNational Taiwan University Hospital·Phase 4·NCT07283887·90 enrolled

A Randomized, Double-Blind, Parallel-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TST002 Injection in Postmenopausal Osteoporosis Patients and Middle-Aged to Older Women With Low Bone Mass

Not yet recruiting·SSuzhou Transcenta Therapeutics Co., Ltd.·Phase 2·NCT07806331·110 enrolled

91 more indications

Low Bone Mineral Density5 trials

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00043186·412 enrolled

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00896532·419 enrolled

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

Completed· Amgen logo

Amgen·Phase 3·NCT00330460·1,189 enrolled

Show 2 more trials

A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00293813·247 enrolled

A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 3·NCT00515463·311 enrolled

Multiple Myeloma5 trials

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Completed· Amgen logo

Amgen·Phase 3·NCT01345019·1,718 enrolled

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab

Completed· Amgen logo

Amgen·Phase 2·NCT00259740·96 enrolled

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

Completed· Amgen logo

Amgen·Phase 3·NCT00330759·1,779 enrolled

Show 2 more trials

Denosumab for Smoldering Multiple Myeloma

Completed·UUniversity of Rochester·Phase 2·NCT03839459·20 enrolled

Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease

Not yet recruiting·RRenJi Hospital·Phase 3·NCT06314698·478 enrolled

Postmenopausal Women5 trials

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women

Unknown status·AAryoGen Pharmed Co.·Phase 3·NCT03293108·190 enrolled

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

Completed· Amgen logo

Amgen·Phase 1·NCT03822078·45 enrolled

Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

Completed·—·N/A·NCT01572545·91 enrolled

Show 2 more trials

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

Completed· Amgen logo

Amgen·Phase 3·NCT00936897·833 enrolled

A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

Completed· Amgen logo

Amgen·Phase 3·NCT00890981·79 enrolled

Bone Metastasis3 trials

Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT01824342·18 enrolled

Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00286091·1,435 enrolled

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Recruiting·WWashington University School of Medicine·Phase 1/2·NCT06374459·152 enrolled

Treatment3 trials

Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

Suspended·MMedical University of Vienna·Phase 4·NCT01734824·90 enrolled

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

Denosumab Treatment in CKD Patients at High Risk of Fracture

Unknown status·—·N/A·NCT05692297·102 enrolled

Biomarkers2 trials

RANKL Inhibition and Breast Tissue Biomarkers

Completed·WWashington University School of Medicine·Phase 1·NCT03629717·10 enrolled

Effect of Denosumab on Cellular Biomarkers in the Human Breast

Completed· Amgen logo

Amgen·Phase 1·NCT02099461·82 enrolled

Chronic Kidney Disease2 trials

Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

Terminated·UUniversity Hospital, Montpellier·Phase 4·NCT02792413·4 enrolled

Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Completed· Amgen logo

Amgen·Phase 1·NCT01464931·32 enrolled

Prostate Cancer2 trials

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

Terminated·UUniversity of Hawaii·Phase 2·NCT02758132·1 enrolled

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00321620·1,904 enrolled

Osteoarthritis2 trials

RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints

Completed·UUniversity Hospital, Ghent·Phase 2·NCT02771860·100 enrolled

Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology··NCT06357741·30 enrolled

Non-Small Cell Lung Cancer2 trials

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Completed· Amgen logo

Amgen·Phase 2·NCT01951586·226 enrolled

Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.

Recruiting·UUniversity of Colorado, Denver··NCT03958565·100 enrolled

Immunogenicity2 trials

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Completed·SSamsung Bioepis Co., Ltd.·Phase 1·NCT04621318·168 enrolled

Comparative Efficacy, Safety, PK, and Immunogenicity Study

Active, not recruiting· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 3·NCT05853354·392 enrolled

Metastatic Prostate Cancer2 trials

Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

Completed· Amgen logo

Amgen·Phase 3·NCT00925600·769 enrolled

Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00838201·384 enrolled

Bone Disease2 trials

Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Completed·SStanley Dudrick's Memorial Hospital·Phase 4·NCT02853539·32 enrolled

Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease

Withdrawn· Amgen logo

Amgen·Phase 4·NCT02101164

Rheumatoid Arthritis2 trials

AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

Completed· Daiichi Sankyo logo

Daiichi Sankyo·N/A·NCT01973569·679 enrolled

Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Completed· Amgen logo

Amgen·Phase 2·NCT00095498·227 enrolled

Spinal Cord Injury2 trials

Denosumab Administration After Spinal Cord Injury

Unknown status·JJames J. Peters Veterans Affairs Medical Center·Phase 4·NCT01983475·24 enrolled

The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury

Terminated·JJames J. Peters Veterans Affairs Medical Center·Phase 4·NCT03029442·5 enrolled

Vertebroplasty2 trials

Denosumab vs Alendronate After Vertebroplasty

Unknown status·SShenzhen People's Hospital·N/A·NCT05662358·90 enrolled

Denosumab vs Zoledronate After Vertebroplasty

Completed·SShenzhen People's Hospital·Phase 4·NCT05598606·75 enrolled

Prevention2 trials

Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

Recruiting·PPeking Union Medical College Hospital·N/A·NCT05866029·2,478 enrolled

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

Active, not recruiting·SSwiss Cancer Institute·Phase 3·NCT02051218·1,380 enrolled

Osteogenesis Imperfecta2 trials

Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta

Terminated· Amgen logo

Amgen·Phase 3·NCT03638128·75 enrolled

Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab

Completed·UUniversity of Cologne·Phase 2·NCT01799798·10 enrolled

Male Infertility2 trials

FITMI - First In Treating Male Infertility

Active, not recruiting·MMartin Blomberg Jensen·Phase 2·NCT05212337·180 enrolled

Denosumab and Male Infertility: a RCT

Completed·MMartin Blomberg Jensen·Phase 2·NCT03030196·95 enrolled

Total Hip Arthroplasty2 trials

Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

Completed·HHans Mallmin·Phase 2·NCT01630941·64 enrolled

Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT01358669·24 enrolled

Fibrous Dysplasia2 trials

Denosumab Treatment for Fibrous Dysplasia

Active, not recruiting·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT03571191·9 enrolled

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

Sarcopenia in Elderly2 trials

RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis: A Randomized, Double-blind, Double-dummy, Active-Controlled Trial

Recruiting·PPrince of Wales Hospital, Shatin, Hong Kong·Approved·NCT06643780·120 enrolled

RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial

Not yet recruiting·PPrince of Wales Hospital, Shatin, Hong Kong·Phase 3·NCT07056478·130 enrolled

Melanoma1 trial

Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT03620019·25 enrolled

Fracture1 trial

Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Unknown status·SShenzhen People's Hospital·Phase 2/3·NCT05106517·122 enrolled

Total Knee Arthroplasty1 trial

The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT02760979·60 enrolled

Arthropathy1 trial

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Completed·WWestern University of Health Sciences·Phase 3·NCT03174366·7 enrolled

Menopausal Women1 trial

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

Completed·EElizabeth Shane·Phase 2·NCT02049866·33 enrolled

Healing1 trial

Effect of Denosumab in Erosion Healing in RA

Completed·—·Phase 2·NCT03239080·110 enrolled

Satisfaction1 trial

Denosumab Adherence Preference Satisfaction Study

Completed· Amgen logo

Amgen·Phase 3·NCT00518531·250 enrolled

Colorectal Cancer1 trial

A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)

Completed·RRedx Pharma Ltd·Phase 2·NCT04907539·25 enrolled

Osteolysis1 trial

Denosumab for Treating Periprosthetic Osteolysis.

Unknown status·OOlof Skoldenberg·Phase 2·NCT02299817·20 enrolled

Chronic1 trial

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Active, not recruiting·VVA Office of Research and Development·Phase 2·NCT04232657·36 enrolled

Stem Cell Transplant1 trial

Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

Completed·RRoswell Park Cancer Institute·Phase 2·NCT03925532·30 enrolled

Amputation1 trial

Osseointegrated Transdermal Femoral Amputation Prostheses

Completed·UUniversity of Aarhus·N/A·NCT05736640·6 enrolled

Metastatic Melanoma1 trial

Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma

Unknown status·MMelanoma and Skin Cancer Trials Limited·Phase 1/2·NCT03161756·72 enrolled

ESS1 trial

Denosumab Safety Assessment in Multiple Observational Databases

Completed· Amgen logo

Amgen··NCT02520362·517,991 enrolled

Bone Marrow Transplantation1 trial

Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children

Withdrawn·SSt. Justine's Hospital·Phase 1·NCT02677246

Osteosarcoma1 trial

Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

Completed·CChildren's Oncology Group·Phase 2·NCT02470091·56 enrolled

Aortic Stenosis1 trial

Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.

Completed·UUniversity of Edinburgh·Phase 2·NCT02132026·152 enrolled

Concentration1 trial

Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose

Completed· Amgen logo

Amgen·Phase 1·NCT01869686·12 enrolled

Metastatic Solid Tumors1 trial

PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors

Unknown status·SSecond Affiliated Hospital of Soochow University··NCT05435768·51 enrolled

Insulin Sensitivity1 trial

The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

Recruiting·—·Phase 4·NCT07271771·40 enrolled

Midazolam1 trial

The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

Completed· Amgen logo

Amgen·Phase 1·NCT01221727·30 enrolled

Children1 trial

Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

Terminated· Amgen logo

Amgen·Phase 3·NCT02352753·153 enrolled

Tics1 trial

Effects of Denosumab on the Pharmacokinetics of Etanercept

Terminated· Amgen logo

Amgen·Phase 1·NCT01294397·19 enrolled

Lumbar Fusion Surgery1 trial

Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

Completed·SShenzhen People's Hospital·N/A·NCT05415657·76 enrolled

Primary Hyperparathyroidism1 trial

Denosumab in Primary Hyperparathyroidism

Terminated·—·Phase 4·NCT01558115·8 enrolled

Bariatric Surgery1 trial

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Completed·MMassachusetts General Hospital·Phase 4·NCT04087096·36 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

Completed· Amgen logo

Amgen·Phase 3·NCT01575873·795 enrolled

Advanced Cancer1 trial

Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT01419717·129 enrolled

Safety and Efficacy1 trial

Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

Completed· Amgen logo

Amgen·Phase 3·NCT00919711·870 enrolled

T Cell1 trial

Denosumab in Subjects With Giant Cell Rich Tumors of Bone

Unknown status·LLeiden University Medical Center·Phase 2·NCT03605199·60 enrolled

Neoadjuvant Treatment1 trial

Denosumab as an add-on Neoadjuvant Treatment (GeparX)

Completed·GGBG Forschungs GmbH·Phase 2·NCT02682693·780 enrolled

Immunosuppression1 trial

Effect of RANKL Inhibition on UV-induced Immunosuppression

Completed·IInnovaderm Research Inc.·Phase 1·NCT01978483·31 enrolled

Systemic Mastocytosis1 trial

Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03401060·24 enrolled

TIA1 trial

Denosumab Sequential Therapy

Completed·NNational Taiwan University Hospital·Phase 4·NCT03868033·101 enrolled

Imaging1 trial

Denosumab and MRI Breast Imaging

Completed·AAlison Stopeck·Phase 2·NCT02613416·42 enrolled

BRCA1/2 Mutation1 trial

Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT03382574·2 enrolled

Prospective1 trial

TNFSF11 Inhibition and Fertility: a Prospective Study

Completed·MMartin Blomberg Jensen·Phase 2·NCT02422108·12 enrolled

Efficacy1 trial

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT03623633·51 enrolled

Advanced NSCLC1 trial

An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting

Recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT06749886·22 enrolled

Completed·MMassachusetts General Hospital·Phase 3·NCT03292146·30 enrolled

Trial1 trial

The DENOCHARCOT Trial

Recruiting·OOle Lander Svendsen·Phase 3·NCT04547348·38 enrolled

Azoospermia1 trial

NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia

Active, not recruiting·MMartin Blomberg Jensen·Phase 1/2·NCT06706414·16 enrolled

Aneurysm1 trial

Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

Completed·PPeking University People's Hospital·Phase 1/2·NCT03415477·6 enrolled

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

Bone Resorption1 trial

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Completed·MMassachusetts General Hospital·Phase 4·NCT01750086·27 enrolled

Breast1 trial

RANKL Inhibition and Mammographic Breast Density

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT04067726·210 enrolled

Phase II1 trial

Denosumab China Phase III Study

Completed· GSK logo

GSK·Phase 3·NCT02014467·486 enrolled

Cystic Fibrosis1 trial

Markers of Osteoporosis in Cystic Fibrosis

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT03921060·100 enrolled

Kidney Cancer1 trial

Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies

Terminated·CCentre Leon Berard·Phase 3·NCT03408652·1 enrolled

Relapsed or Refractory1 trial

Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01624766·57 enrolled

Idiopathic Inflammatory Myopathies1 trial

Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid

Unknown status·KKwong Wah Hospital·Phase 3·NCT04034199·40 enrolled

Tic Disorder1 trial

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

Withdrawn·IIndiana University·Phase 1/2·NCT02418273

Bone Metastases1 trial

4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

Completed·OOttawa Hospital Research Institute·Phase 4·NCT02721433·263 enrolled

Oligospermia1 trial

NAPO - Novel Approach for Oligospermia

Completed·MMartin Blomberg Jensen·Phase 1/2·NCT06300229·42 enrolled

Hypercalcemia1 trial

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

Completed· Amgen logo

Amgen·Phase 2·NCT00896454·33 enrolled

Crohn's Disease1 trial

The Efficacy of Denosumab in Active Crohn's Disease

Completed·UUniversity of Manitoba·Phase 1/2·NCT02321280·2 enrolled

Metabolism1 trial

Circulating Myokine Levels and Bone Metabolism

Completed·—··NCT04206618·220 enrolled

Urothelial Cancer1 trial

Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases

Completed·UUniversity Health Network, Toronto·Phase 2·NCT03520231·6 enrolled

Advanced Solid Tumours1 trial

A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)

Completed·RRedx Pharma Ltd·Phase 2·NCT04907851·45 enrolled

Observational Study1 trial

Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

Completed· Amgen logo

Amgen··NCT01652690·600 enrolled

Lung Cancer Non-small Cell Stage IV1 trial

A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC

Terminated·EETOP IBCSG Partners Foundation·Phase 3·NCT02129699·595 enrolled

Osteoporosis in Post-menopausal Women1 trial

Short-course Romosozumab Followed by Denosumab Versus Zoledronic Acid: A Multicentre Randomized Active-controlled Trial in Postmenopausal Women at High Fracture Risk

Not yet recruiting·SSahlgrenska University Hospital·Approved·NCT07772609·216 enrolled

Osteopenia1 trial

Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Randomized Controlled Trial At 6 Years

Not yet recruiting·TTuen Mun Hospital·Approved·NCT07757373·54 enrolled

Type 1 Diabetes1 trial

A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes

Recruiting·CCity of Hope Medical Center·Preclinical·NCT06524960·45 enrolled

Nonalcoholic Fatty Liver1 trial

Effect of Anti-osteoporotic Medications on Hepatic Steatosis and Fibrosis of Women With Postmenopausal Osteoporosis and Nonalcoholic Fatty Liver Disease

Completed·AAristotle University Of Thessaloniki·Approved·NCT05493761·72 enrolled

Osteoporosis, Postmenopausal1 trial

Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study

Recruiting·4424 General Military Hospital··NCT06164795·150 enrolled

Unspecified9 trials

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Completed·TTuen Mun Hospital·Phase 4·NCT03005678·140 enrolled

Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study

Recruiting·TTuen Mun Hospital·Phase 4·NCT06472050·63 enrolled

Longjohn Amgen Study - Effect of Denosumab...

Withdrawn·UUniversity of Southern California·Phase 1·NCT02444585

Show 6 more trials

Study of Transitioning From Alendronate to Denosumab

Completed· Amgen logo

Amgen·Phase 3·NCT00377819·504 enrolled

China HVT Safety, PK, PD

Completed· GSK logo

GSK·Phase 1·NCT02135640·64 enrolled

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Active, not recruiting·HHospital for Special Surgery, New York·Phase 4·NCT04467983·70 enrolled

AVT03 With Xgeva in Healthy Male Subjects

Completed·AAlvotech Swiss AG·Phase 1·NCT05876949·208 enrolled

Effects of Denosumab Therapy for Japanese

Unknown status·—··NCT02491515·500 enrolled

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Completed·MMassachusetts General Hospital·Phase 4·NCT02176382·76 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 1, 2010

PROLIA

BLA BLA125320

Jun 1, 2010

PROLIA, XGEVA

NDA BLA125320

Nov 18, 2010

PROLIA, XGEVA

NDA BLA125320

Jul 22, 2011

PROLIA, XGEVA

NDA BLA125320

Sep 16, 2011

PROLIA, XGEVA

NDA BLA125320

Sep 16, 2011

PROLIA, XGEVA

NDA BLA125320

Apr 27, 2012

PROLIA, XGEVA

NDA BLA125320

May 10, 2012

PROLIA, XGEVA

NDA BLA125320

Jun 7, 2012

PROLIA, XGEVA

NDA BLA125320

Sep 14, 2012

PROLIA, XGEVA

NDA BLA125320

Sep 20, 2012

PROLIA, XGEVA

NDA BLA125320

Feb 15, 2013

PROLIA, XGEVA

NDA BLA125320

Jun 13, 2013

PROLIA, XGEVA

NDA BLA125320

Jul 3, 2013

PROLIA, XGEVA

NDA BLA125320

Aug 23, 2013

PROLIA, XGEVA

NDA BLA125320

Aug 23, 2013

PROLIA, XGEVA

NDA BLA125320

Jun 4, 2014

PROLIA, XGEVA

NDA BLA125320

Jun 16, 2014

PROLIA, XGEVA

NDA BLA125320

Dec 5, 2014

PROLIA, XGEVA

NDA BLA125320

Feb 26, 2015

PROLIA, XGEVA

NDA BLA125320

Apr 8, 2015

PROLIA, XGEVA

NDA BLA125320

May 21, 2015

PROLIA, XGEVA

NDA BLA125320

Jun 8, 2015

PROLIA, XGEVA

NDA BLA125320

Mar 2, 2016

PROLIA, XGEVA

NDA BLA125320

Aug 5, 2016

PROLIA, XGEVA

NDA BLA125320

Jan 31, 2017

PROLIA, XGEVA

NDA BLA125320

May 26, 2017

PROLIA, XGEVA

NDA BLA125320

Jan 4, 2018

PROLIA, XGEVA

NDA BLA125320

Jan 24, 2018

PROLIA, XGEVA

NDA BLA125320

May 18, 2018

PROLIA, XGEVA

NDA BLA125320

Jun 7, 2018

PROLIA, XGEVA

NDA BLA125320

Apr 30, 2019

PROLIA, XGEVA

NDA BLA125320

May 8, 2019

PROLIA, XGEVA

NDA BLA125320

May 8, 2019

PROLIA, XGEVA

NDA BLA125320

May 24, 2019

PROLIA, XGEVA

NDA BLA125320

Jul 26, 2019

PROLIA, XGEVA

NDA BLA125320

Oct 1, 2019

PROLIA, XGEVA

NDA BLA125320

Feb 10, 2020

PROLIA, XGEVA

NDA BLA125320

Apr 23, 2020

PROLIA, XGEVA

NDA BLA125320

Jun 9, 2020

PROLIA, XGEVA

NDA BLA125320

May 12, 2021

PROLIA, XGEVA

NDA BLA125320

May 19, 2022

PROLIA, XGEVA

NDA BLA125320

Jan 3, 2023

PROLIA, XGEVA

NDA BLA125320

Jan 19, 2024

PROLIA, XGEVA

NDA BLA125320

Mar 5, 2024

PROLIA, XGEVA

NDA BLA125320

Mar 5, 2024

WYOST

BLA BLA761362

Mar 5, 2024

PROLIA, XGEVA

NDA BLA125320

Apr 9, 2024

PROLIA, XGEVA

NDA BLA125320

Feb 13, 2025

OSPOMYV

BLA BLA761392

Mar 25, 2025

CONEXXENCE

BLA BLA761398

Apr 28, 2025

PROLIA, XGEVA

NDA BLA125320

May 22, 2025

PROLIA, XGEVA

NDA BLA125320

May 30, 2025

PROLIA, XGEVA

NDA BLA125320

Aug 29, 2025

BILPREVDA

BLA BLA761444

Jun 23, 2026

PROLIA, XGEVA

NDA BLA125320

Jun 23, 2026

PROLIA, XGEVA

NDA BLA125320

Sources

References

[1]
ClinicalTrials.gov — 186 trial records for Denosumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prolia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Denosumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Denosumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125320). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tumor Necrosis Factor Ligand Superfamily Member 11 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Prolia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Osteoporosis21 trials

Breast Cancer14 trials

Giant Cell Tumor7 trials

Bone6 trials

Postmenopausal Osteoporosis6 trials

Low Bone Mineral Density5 trials

Multiple Myeloma5 trials

Postmenopausal Women5 trials

Bone Metastasis3 trials

Treatment3 trials

Biomarkers2 trials

Chronic Kidney Disease2 trials

Prostate Cancer2 trials

Osteoarthritis2 trials

Non-Small Cell Lung Cancer2 trials

Immunogenicity2 trials

Metastatic Prostate Cancer2 trials

Bone Disease2 trials

Rheumatoid Arthritis2 trials

Spinal Cord Injury2 trials

Vertebroplasty2 trials

Prevention2 trials

Osteogenesis Imperfecta2 trials

Male Infertility2 trials

Total Hip Arthroplasty2 trials

Fibrous Dysplasia2 trials

Sarcopenia in Elderly2 trials

Melanoma1 trial

Fracture1 trial

Total Knee Arthroplasty1 trial

Arthropathy1 trial

Menopausal Women1 trial

Healing1 trial

Satisfaction1 trial

Colorectal Cancer1 trial

Osteolysis1 trial

Chronic1 trial

Stem Cell Transplant1 trial

Amputation1 trial

Metastatic Melanoma1 trial

ESS1 trial

Bone Marrow Transplantation1 trial

Osteosarcoma1 trial

Aortic Stenosis1 trial

Concentration1 trial

Metastatic Solid Tumors1 trial

Insulin Sensitivity1 trial

Midazolam1 trial

Children1 trial

Tics1 trial

Lumbar Fusion Surgery1 trial

Primary Hyperparathyroidism1 trial

Bariatric Surgery1 trial

Efficacy and Safety1 trial

Advanced Cancer1 trial

Safety and Efficacy1 trial

T Cell1 trial

Neoadjuvant Treatment1 trial

Immunosuppression1 trial

Systemic Mastocytosis1 trial

TIA1 trial

Imaging1 trial

BRCA1/2 Mutation1 trial

Prospective1 trial

Efficacy1 trial

Advanced NSCLC1 trial

High Risk1 trial

Liver Transplant1 trial

Anorexia Nervosa1 trial

Trial1 trial

Azoospermia1 trial

Aneurysm1 trial