Denosumab

Generic Name: Denosumab

Brand Names: Prolia, Xgeva, Wyost, Jubbonti

Drug Type: Biotech

CAS Number: 615258-40-7

Unique Ingredient Identifier: 4EQZ6YO2HI

Background: Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. FDA approved on June 1, 2010.

Indication: Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Associated Conditions: Bone Fractures, Bone Giant Cell Tumor, Bone Loss, Bone pain, Spinal Cord Compression, Bone destruction, High risk of fracture Osteoporosis, Refractory Hypercalcemia of malignancy

Clinical Trials

A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

Phase 3

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: LY06006

First Posted Date: 2021-09-29

Last Posted Date: 2021-09-29

Lead Sponsor: Luye Pharma Group Ltd.

Target Recruit Count: 448

Registration Number: NCT05060406

Locations: 🇨🇳
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China

Denosumab and Osteoporotic Vertebral Compression Fracture

Phase 2

Completed

Conditions: Osteoporotic Vertebral Compression Fracture

Interventions: Drug: Denosumab 60 mg/ml [Prolia]
Drug: Placebo

First Posted Date: 2021-09-27

Last Posted Date: 2023-02-21

Lead Sponsor: Shenzhen People's Hospital

Target Recruit Count: 90

Registration Number: NCT05058443

Locations: 🇨🇳
ShenzhenPH, Shenzhen, Guangdong, China

Anabolic Therapy in Postmenopausal Osteoporosis

Phase 4

Active, not recruiting

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: Romosozumab
Drug: Denosumab

First Posted Date: 2021-08-18

Last Posted Date: 2024-12-04

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 50

Registration Number: NCT05010590

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Study to Evaluate LY06006 and Prolia in Healthy Adults

Phase 1

Conditions: Healthy Adults

Interventions: Drug: Prolia
Drug: LY06006

First Posted Date: 2021-07-22

Last Posted Date: 2021-07-22

Lead Sponsor: Luye Pharma Group Ltd.

Target Recruit Count: 168

Registration Number: NCT04973722

Locations: 🇨🇳
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China

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

Phase 1

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: HS-20090-2
Drug: Prolia

First Posted Date: 2021-06-28

Last Posted Date: 2021-08-25

Lead Sponsor: Shanghai Hansoh Biomedical Co., Ltd

Target Recruit Count: 174

Registration Number: NCT04940845

Locations: 🇨🇳
Huazhong University of Science and Technoogy, Wuhan, Hubei, China

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Phase 3

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: US-licensed Prolia (Amgen)
Drug: FKS518

First Posted Date: 2021-06-22

Last Posted Date: 2025-02-27

Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Target Recruit Count: 553

Registration Number: NCT04934072

Locations: 🇧🇬
Medical Center Medconsult Pleven, Pleven, Bulgaria
🇬🇪
Hepatology Clinic Hepa, Tbilisi, Georgia
🇬🇪
Tbilisi Heart And Vascular Clinic Ltd, Tbilisi, Georgia

and more 64 locations

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

Phase 2

Completed

Conditions: Advanced Solid Tumours

Interventions: Drug: RXC004
Biological: Denosumab
Biological: pembrolizumab

First Posted Date: 2021-06-01

Last Posted Date: 2025-03-17

Lead Sponsor: Redx Pharma Ltd

Target Recruit Count: 45

Registration Number: NCT04907851

Locations: 🇦🇺
The Alfred Hospital - Alfred Health, Melbourne, Victoria, Australia
🇦🇺
Wollongong Hospital, Wollongong, New South Wales, Australia
🇬🇧
Barts Cancer Institute - Haemato-Oncology, London, United Kingdom

and more 10 locations

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)

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: RXC004
Biological: Nivolumab
Biological: Denosumab

First Posted Date: 2021-05-28

Last Posted Date: 2025-04-16

Lead Sponsor: Redx Pharma Ltd

Target Recruit Count: 25

Registration Number: NCT04907539

Locations: 🇺🇸
Providence Medical Foundation, Santa Rosa, California, United States
🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Community Health Network Cancer Center North - Community Hospital Network, Indianapolis, Indiana, United States

and more 19 locations