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Prolia® (Denosumab)
Prolia® (Denosumab) is a Monoclonal antibody Small molecule drug developed by Samsung Bioepis Co., Ltd.. It is currently in Phase 3 development for Treatment of osteoporosis in postmenopausal women, Treatment of bone loss in patients with hormone ablation for prostate cancer, Treatment of bone loss in patients with hormone receptor-positive breast cancer.
Prolia works by binding to RANKL, a protein involved in the formation and activation of osteoclasts, which are cells that break down bone.
Prolia works by binding to RANKL, a protein involved in the formation and activation of osteoclasts, which are cells that break down bone. Used for Treatment of osteoporosis in postmenopausal women, Treatment of bone loss in patients with hormone ablation for prostate cancer, Treatment of bone loss in patients with hormone receptor-positive breast cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Prolia® (Denosumab) |
|---|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
| Drug class | Monoclonal antibody |
| Target | RANKL |
| Modality | Small molecule |
| Therapeutic area | Osteoporosis, Bone-related disorders |
| Phase | Phase 3 |
Mechanism of action
By binding to RANKL, denosumab inhibits the formation and activation of osteoclasts, leading to a decrease in bone resorption and an increase in bone density. This mechanism of action is particularly useful in the treatment of osteoporosis and other bone-related disorders.
Approved indications
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss in patients with hormone ablation for prostate cancer
- Treatment of bone loss in patients with hormone receptor-positive breast cancer
- Treatment of giant cell tumor of bone
- Treatment of osteogenesis imperfecta
Common side effects
- Musculoskeletal pain
- Fatigue
- Back pain
- Headache
- Influenza
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® (Denosumab) CI brief — competitive landscape report
- Prolia® (Denosumab) updates RSS · CI watch RSS
- Samsung Bioepis Co., Ltd. portfolio CI
Frequently asked questions about Prolia® (Denosumab)
What is Prolia® (Denosumab)?
How does Prolia® (Denosumab) work?
What is Prolia® (Denosumab) used for?
Who makes Prolia® (Denosumab)?
What drug class is Prolia® (Denosumab) in?
What development phase is Prolia® (Denosumab) in?
What are the side effects of Prolia® (Denosumab)?
What does Prolia® (Denosumab) target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting RANKL
- Manufacturer: Samsung Bioepis Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Osteoporosis, Bone-related disorders
- Indication: Drugs for Treatment of osteoporosis in postmenopausal women
- Indication: Drugs for Treatment of bone loss in patients with hormone ablation for prostate cancer
- Indication: Drugs for Treatment of bone loss in patients with hormone receptor-positive breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing