Denosumab
RANK Ligand Inhibitor — MUSCULO-SKELETAL SYSTEM
Also known as: AMG 162, AMG162, prolia
Data last refreshed: (DrugCentral release 2024-11-01)
Key facts
Denosumab is a drug in the RANK Ligand Inhibitor class catalogued in DrugCentral. It was first approved by the EMA in 2010. Its mechanism of action is classified as RANK Ligand Blocking Activity. DrugCentral lists 1 molecular target, including TNFSF11. Recorded indications include Drug-induced osteoporosis, Osteoporosis and Postmenopausal osteoporosis.
- Drug class: RANK Ligand Inhibitor.
- Mechanism of action: RANK Ligand Blocking Activity.
- Molecular targets: TNFSF11 (1 listed in DrugCentral).
- Indications: Drug-induced osteoporosis, Osteoporosis and Postmenopausal osteoporosis.
- ATC code: M05BX04 (Other drugs affecting bone structure and mineralization).
Indications & contraindications
Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).
Indications (3)
- Drug-induced osteoporosis
- Osteoporosis
- Postmenopausal osteoporosis
Mechanism & targets
| Mechanism of action (MoA) | RANK Ligand Blocking Activity |
|---|---|
| Established pharmacologic class | RANK Ligand Inhibitor |
Molecular targets (1)
| Target | Gene | Action | Activity |
|---|---|---|---|
| Tumor necrosis factor ligand superfamily member 11 | TNFSF11 | other | — |
Regulatory approvals (2)
| Date | Agency | Marketed as | Applicant | Orphan |
|---|---|---|---|---|
| 2010-06-01 | FDA | — | AMGEN | |
| 2010-05-26 | EMA | — | Amgen Europe B.V. |
ATC classification
| ATC code | Therapeutic hierarchy |
|---|---|
M05BX04 | MUSCULO-SKELETAL SYSTEM › DRUGS FOR TREATMENT OF BONE DISEASES › DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION › Other drugs affecting bone structure and mineralization |
Reported adverse-event signals
Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.
| MedDRA term | LLR |
|---|---|
| Off label use | 38114.0 |
| Osteonecrosis of jaw | 25751.9 |
| Death | 8842.9 |
| Hypocalcaemia | 5670.6 |
| Spinal fracture | 4790.9 |
| Product storage error | 4027.5 |
| Bone pain | 3015.1 |
| Tooth disorder | 2862.3 |
| Intercepted product administration error | 2697.8 |
| Atypical femur fracture | 2566.1 |
| Pain in jaw | 2140.0 |
| Tooth extraction | 2054.9 |
Chemical structure
| Molecular formula | — |
|---|---|
| Molecular weight | — |
| CAS number | 615258-40-7 |
| InChIKey | — |
| PubChem CID | — |
Frequently asked questions
Answers are generated from the structured data on this page, not written by hand.
What is Denosumab used for?
DrugCentral lists the following indications for Denosumab: Drug-induced osteoporosis, Osteoporosis and Postmenopausal osteoporosis.
How does Denosumab work?
Denosumab is classified as RANK Ligand Blocking Activity; its molecular targets in DrugCentral include TNFSF11.
When was Denosumab first approved?
Denosumab was first approved by the EMA in 2010.
What drug class does Denosumab belong to?
Denosumab is in the RANK Ligand Inhibitor class.
Browse: all drugs starting with D · drug guides by category · protein targets A–Z.
Sources
- DrugCentral drug card 4965 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
- ChEMBL CHEMBL1237023 — compound record and bioactivity
- DrugBank DB06643 — drug record
- FDA UNII 4EQZ6YO2HI — substance identity
- DailyMed: FDA labels for Denosumab — current prescribing information (label search)
- UniProt O14788 (TNFSF11) — target protein
- FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
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