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

DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)

Phase 4

Recruiting

Conditions: Fibrous Dysplasia
McCune Albright Syndrome

Interventions: Drug: Denosumab 120 Mg/1.7 Ml Inj
Drug: Placebo

First Posted Date: 2023-07-28

Last Posted Date: 2025-01-29

Lead Sponsor: Natasha Appelman-Dijkstra

Target Recruit Count: 82

Registration Number: NCT05966064

Locations: 🇳🇱
Leiden University Medical Center, Leiden, Netherlands

Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.

Phase 4

Recruiting

Conditions: Osteoporosis in Postmenopausal Women

Interventions: Drug: Eldecalcitol
Drug: Native Vitamin D
Drug: Denosumab
Drug: Calcium

First Posted Date: 2023-06-01

Last Posted Date: 2024-02-21

Lead Sponsor: Xi'an Honghui Hospital

Target Recruit Count: 100

Registration Number: NCT05884372

Locations: 🇨🇳
Zeng,Yuhong, Xi'an, China

AVT03 With Xgeva in Healthy Male Subjects

Phase 1

Completed

Conditions: This is a Phase I Study Conducted in Healthy Volunteers

Interventions: Biological: AVT03
Biological: Denosumab

First Posted Date: 2023-05-26

Last Posted Date: 2025-05-15

Lead Sponsor: Alvotech Swiss AG

Target Recruit Count: 208

Registration Number: NCT05876949

Locations: 🇵🇱
Biokinetica, Józefów, Poland
🇬🇧
Richmond Pharmacology, London, United Kingdom
🇿🇦
Farmovs, Bloemfontein, South Africa

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

Not Applicable

Recruiting

Conditions: Osteoporotic Fractures

Interventions: Drug: Denosumab
Drug: Teriparatide

First Posted Date: 2023-05-19

Last Posted Date: 2024-10-24

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 2478

Registration Number: NCT05866029

Locations: 🇨🇳
Beijing Friendship Hospital, Capital Medical University, Beijing, China
🇨🇳
Beijing Hospital, Beijing, China
🇨🇳
Beijing Pinggu Hospital, Beijing, China

and more 55 locations