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US-licensed Prolia (Amgen)
US-licensed Prolia (Amgen) is a Denosumab Small molecule drug developed by Fresenius Kabi SwissBioSim GmbH. It is currently in Phase 3 development for Treatment of osteoporosis in postmenopausal women at high risk of fracture, treatment to increase bone mass in men with osteoporosis, treatment to increase bone mass in women with osteoporosis due to sustained systemic glucocorticoid therapy, treatment of bone loss associated with hormone ablation in men with prostate cancer, treatment of bone loss in women with breast cancer, treatment of giant cell tumor of bone, treatment of hypercalcemia of malignancy, treatment of multiple myeloma, treatment of bone metastases in men with prostate cancer, treatment of bone metastases in women with breast cancer. Also known as: Denosumab.
Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.
US-licensed Prolia (Amgen) is used to treat postmenopausal osteoporosis. It works by inhibiting interleukin-6, a protein involved in bone resorption.
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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 | US-licensed Prolia (Amgen) |
|---|---|
| Also known as | Denosumab |
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Drug class | Denosumab |
| Target | RANKL |
| Modality | Small molecule |
| Therapeutic area | Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
By binding to RANKL, Prolia inhibits the formation of osteoclasts, which are cells responsible for bone breakdown. This leads to an increase in bone mass and a decrease in the risk of fractures. Prolia is administered via subcutaneous injection and has a half-life of approximately 28 days.
Approved indications
- Treatment of osteoporosis in postmenopausal women at high risk of fracture, treatment to increase bone mass in men with osteoporosis, treatment to increase bone mass in women with osteoporosis due to sustained systemic glucocorticoid therapy, treatment of bone loss associated with hormone ablation in men with prostate cancer, treatment of bone loss in women with breast cancer, treatment of giant cell tumor of bone, treatment of hypercalcemia of malignancy, treatment of multiple myeloma, treatment of bone metastases in men with prostate cancer, treatment of bone metastases in women with breast cancer
Common side effects
- back pain
- musculoskeletal pain
- hypocalcemia
- dizziness
- nausea
Key clinical trials
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:
- US-licensed Prolia (Amgen) CI brief — competitive landscape report
- US-licensed Prolia (Amgen) updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI
Frequently asked questions about US-licensed Prolia (Amgen)
What is US-licensed Prolia (Amgen)?
How does US-licensed Prolia (Amgen) work?
What is US-licensed Prolia (Amgen) used for?
Who makes US-licensed Prolia (Amgen)?
Is US-licensed Prolia (Amgen) also known as anything else?
What drug class is US-licensed Prolia (Amgen) in?
What development phase is US-licensed Prolia (Amgen) in?
What are the side effects of US-licensed Prolia (Amgen)?
What does US-licensed Prolia (Amgen) target?
Related
- Drug class: All Denosumab drugs
- Target: All drugs targeting RANKL
- Manufacturer: Fresenius Kabi SwissBioSim GmbH — full pipeline
- Therapeutic area: All drugs in Osteoporosis
- Indication: Drugs for Treatment of osteoporosis in postmenopausal women at high risk of fracture, treatment to increase bone mass in men with osteoporosis, treatment to increase bone mass in women with osteoporosis due to sustained systemic glucocorticoid therapy, treatment of bone loss associated with hormone ablation in men with prostate cancer, treatment of bone loss in women with breast cancer, treatment of giant cell tumor of bone, treatment of hypercalcemia of malignancy, treatment of multiple myeloma, treatment of bone metastases in men with prostate cancer, treatment of bone metastases in women with breast cancer
- Also known as: Denosumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing