Evenity(romosozumab)
Evenity (romosozumab) is an antibody pharmaceutical. Romosozumab was first approved as Evenity on 2019-04-09. It is used to treat postmenopausal osteoporosis in the USA. It has been approved in Europe to treat osteoporosis. The pharmaceutical is active against sclerostin.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Evenity
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| evenity | Biologic Licensing Application | 2024-04-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3111 | Injection, romosozumab-aqqg, 1 mg |
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 3 | 4 | 8 | 9 | 2 | 26 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 2 | 5 | 4 | 2 | 13 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 4 | 2 | 1 | 1 | — | 8 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 2 | — | 2 | — | 4 |
| Osteoporotic fractures | D058866 | — | — | — | — | — | 2 | — | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteogenesis imperfecta | D010013 | — | Q78.0 | 1 | — | 1 | — | — | 2 |
| Anorexia | D000855 | HP_0002039 | R63.0 | — | — | 1 | — | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | 1 | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 1 | — | — | 1 |
| Amenorrhea | D000568 | — | N91.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | 2 | — | — | — | 2 |
| Fracture healing | D017102 | — | — | — | 2 | — | — | — | 2 |
| Paralysis | D010243 | HP_0003470 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Postmenopause | D017698 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Romosozumab |
| INN | romosozumab |
| Description | Romosozumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107874 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11866 |
| UNII ID | 3VHF2ZD92J (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
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Evenity – Amgen
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,166 documents
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Safety
Black-box Warning
Black-box warning for: Evenity
Adverse Events
Top Adverse Reactions
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8,474 adverse events reported
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