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EU-Prolia
EU-Prolia is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to reduce osteoclast formation and bone resorption.
EU-Prolia is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to reduce osteoclast formation and bone resorption. Used for Osteoporosis in postmenopausal women, Bone loss in patients with cancer or receiving cancer therapy.
At a glance
| Generic name | EU-Prolia |
|---|---|
| Sponsor | Luye Pharma Group Ltd. |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Biologic |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
By binding to RANKL, EU-Prolia prevents the interaction between RANKL and its receptor RANK on osteoclast precursor cells, thereby suppressing osteoclast differentiation and activation. This leads to decreased bone resorption and increased bone mineral density, making it useful in conditions characterized by excessive bone loss.
Approved indications
- Osteoporosis in postmenopausal women
- Bone loss in patients with cancer or receiving cancer therapy
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
Key clinical trials
- Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers (PHASE1)
- Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® (PHASE1)
- A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis. (PHASE3)
- Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects (PHASE1)
- A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (PHASE1)
- Comparative Efficacy, Safety, PK, and Immunogenicity Study (PHASE3)
- A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection (PHASE1)
- Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis (PHASE3)
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:
- EU-Prolia CI brief — competitive landscape report
- EU-Prolia updates RSS · CI watch RSS
- Luye Pharma Group Ltd. portfolio CI