Drug profile · INN
denosumab
CORORA
denosumab (CORORA) is a tumor necrosis factor ligand superfamily member 11 inhibitor. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.
Drug details — denosumab
- US status
- approved
- Class
- Musculo-skeletal system (M05)
- Route
- SUBCUTANEOUS
- Patents
- 5
- Programs
- 8
- Data quality
- 0.89
Quick answer
denosumab (CORORA) is a tumor necrosis factor ligand superfamily member 11 inhibitor. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.
Key facts
Mechanism of action
Tumor necrosis factor ligand superfamily member 11 inhibitor
Primary target: Tumor necrosis factor ligand superfamily member 11
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
Recent coverage
EMA approved 104 human medicines in 2025: what changed
EMA recommended 104 medicines for marketing authorisation in 2025, with 38 new active substances and a record biosimilar share. The update matters for BD teams, investors, and analysts tracking EU regulatory catalysts and near-term competitive readouts.
Rise of Biosimilars in US: FDA Approval Trends & Market Impact
The article delves into the growing presence of biosimilars in the US market, focusing on FDA approval trends and their implications for drug pricing and patient access.
Denosumab Biosimilar Authorization by EMA: Key Details
The EMA has authorized Denosumab biosimilars, marking a significant advancement in osteoporosis treatment and improving patient access to effective therapies.
Pipeline programs
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Frequently asked questions
What is denosumab?
denosumab (CORORA) is a tumor necrosis factor ligand superfamily member 11 inhibitor. Associated with Amgen. Route of administration: subcutaneous. Current US regulatory status: approved.
What is the brand name for denosumab?
CORORA is a marketed brand name for denosumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of denosumab?
denosumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.