Drug · Monoclonal Antibody
Denosumab
CI-DRUG-00000793Explore in graph →CHEMBL1237023 Approved
Regulatory
Approvals (62)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. | approved | Oct 29, 2025 | openfda |
| US FDA | Malignant Prostate Neoplasm | to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer | approved | Oct 29, 2025 | openfda |
| US FDA | Malignant Breast Neoplasm | to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer | approved | Oct 29, 2025 | openfda |
| US FDA | — | of postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for fracture • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture |
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 10 | 2 | 27 | 71 | 62 | EU, US | May 26, 2010 | Aug 1, 2004 |
| Malignant Breast Neoplasm | Approved | Phase 4 | 3 | 0 | 5 | 18 | 6 | US | Jun 1, 2010 | 2004-09 |
| Malignant Prostate Neoplasm | Approved | Phase 4 | 1 | 0 | 4 | 7 | 6 | US | Jun 1, 2010 | Aug 1, 2004 |
| Multiple Myeloma | Approved | Phase 3 | 1 | 0 | 2 | 6 | 2 | US |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (75)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT01545648 | Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer | terminated | Phase 2 | 4 | Hope Rugo, MDOTHER | 1 | Jan 2, 2020 | clinicaltrials |
| NCT01952054 | Denosumab for Breast Cancer With Bone Mets | terminated | Phase 2 | 7 |