Last reviewed · How we verify
Prolia®
At a glance
| Generic name | Prolia® |
|---|---|
| Also known as | Denosumab Injection, Denosumab |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (PHASE4)
- A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® (PHASE3)
- Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (PHASE3)
- Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers (PHASE1)
- Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone (PHASE4)
- Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (PHASE3)
- Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (PHASE4)
- Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prolia® CI brief — competitive landscape report
- Prolia® updates RSS · CI watch RSS
- Qilu Pharmaceutical Co., Ltd. portfolio CI