Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| M05BX04 | Denosumab | M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BX Other drugs affecting bone structure and mineralization |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| PROLIA Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
| WYOST Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
Denosumab is an active ingredient of these brands:
South Africa (ZA)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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