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EU-sourced Xgeva
EU-sourced Xgeva is a RANKL inhibitor Small molecule drug developed by mAbxience Research S.L.. It is currently in Phase 1 development. Also known as: EU-licensed Xgeva.
Binds to and inhibits RANKL, preventing osteoclast formation and bone resorption.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | EU-sourced Xgeva |
|---|---|
| Also known as | EU-licensed Xgeva |
| Sponsor | mAbxience Research S.L. |
| Drug class | RANKL inhibitor |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Denosumab is a fully human monoclonal antibody that binds to RANKL with high affinity and specificity, preventing RANKL from activating its receptor RANK on osteoclast precursors and osteoclasts. This inhibition reduces osteoclast-mediated bone resorption and increases bone mass and strength.
Approved indications
Common side effects
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)
- A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (PHASE1)
- Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects (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:
- EU-sourced Xgeva CI brief — competitive landscape report
- EU-sourced Xgeva updates RSS · CI watch RSS
- mAbxience Research S.L. portfolio CI
Frequently asked questions about EU-sourced Xgeva
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Related
- Drug class: All RANKL inhibitor drugs
- Manufacturer: mAbxience Research S.L. — full pipeline
- Also known as: EU-licensed Xgeva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing