Denosumab

Summary

Denosumab (CHEMBL1237023) is an approved antibody (ATC M05BX04); indicated across 43 conditions including breast carcinoma and osteoporosis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: M05BX04
• Indications: 43 conditions
• Clinical trials: 233

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1237023
Name	Denosumab
Type	Antibody
Max phase	4
ATC	M05BX04

Also known as: AMG 162, AMG-162, AMG162, Ct-p41, CTP-41, CTP41, Denosumab, Denosumab biosimilar (ct-p41), Denosumab biosimilar (hlx-14), Denosumab biosimilar (ql-1206), Denosumab biosimilar tk-006, Denosumab-bbdz

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

43 indications (13 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
breast carcinoma	4	MONDO:0004989	EFO:0000305
osteoporosis	4	MONDO:0005298	EFO:0003882
postmenopausal osteoporosis	4	MONDO:0008159	EFO:0003854
breast neoplasm	4	MONDO:0021100	EFO:0003869
hypercalcemia disease	4	MONDO:0001566	HP:0003072
bone disorder	4	MONDO:0005381	EFO:0004260
giant cell tumor	4	MONDO:0002171	MONDO:0002171
bone giant cell tumor	4	MONDO:0005674	EFO:0007176
bone resorption disease	4	MONDO:0000837	MONDO:0000837
bone neoplasm	4	MONDO:0019060	EFO:0003820
rheumatoid arthritis	3	MONDO:0008383	EFO:0000685
renal cell carcinoma	3	MONDO:0005086	EFO:0000681
bone fracture	3	MONDO:0005315	EFO:0003931
lung neoplasm	3	MONDO:0021117	MONDO:0008903
diabetes mellitus	3	MONDO:0005015	EFO:0000400
carcinoma	3	MONDO:0004993	EFO:0000313
osteogenesis imperfecta	3	MONDO:0019019	MONDO:0019019
anorexia nervosa	3	MONDO:0005351	MONDO:0005351
aortic valve stenosis	2	MONDO:0042981	EFO:0000266
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
plasma cell myeloma	2	MONDO:0009693	EFO:0001378
osteosarcoma	2	MONDO:0009807	EFO:0000637
gout	2	MONDO:0005393	EFO:0004274
osteoarthritis, hip	2	MONDO:0006629	EFO:1000786
melanoma	2	MONDO:0005105	EFO:0000756
male infertility	2	MONDO:0005372	EFO:0004248
Langerhans cell histiocytosis	2	MONDO:0018310	EFO:1000318
cutaneous melanoma	2	MONDO:0005012	EFO:0000389
inflammatory breast carcinoma	2	MONDO:0006804	EFO:1000984
neoplasm	2	MONDO:0005070	EFO:0000616
fibrous dysplasia	2	MONDO:0000845	MONDO:0000845
allergic disease	2	MONDO:0005271	MONDO:0005271
lytic metastatic bone lesion	2	MONDO:0043731	HP:0002797
colorectal neoplasm	2	MONDO:0005335	MONDO:0005575
Crohn disease	1	MONDO:0005011	EFO:0000384
kidney disorder	1	MONDO:0005240	EFO:0003086
ovarian carcinoma	0	MONDO:0005140	EFO:0001075

6 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 233.

Phase distribution

Phase	Trials
PHASE3	60
PHASE2	60
PHASE4	47
PHASE1	29
Not specified	21
PHASE1/PHASE2	8
EARLY_PHASE1	5
PHASE2/PHASE3	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03623633	PHASE4	ACTIVE_NOT_RECRUITING	Comparative Antiresorptive Efficacy Discontinuation of Denosumab
NCT03921060	PHASE4	RECRUITING	Markers of Osteoporosis in Cystic Fibrosis
NCT04467983	PHASE4	ACTIVE_NOT_RECRUITING	Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
NCT05010590	PHASE4	ACTIVE_NOT_RECRUITING	Anabolic Therapy in Postmenopausal Osteoporosis
NCT05091086	PHASE4	ACTIVE_NOT_RECRUITING	The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
NCT05096195	PHASE4	ACTIVE_NOT_RECRUITING	PRevEnting FracturEs in REnal Disease - 1
NCT05101018	PHASE4	ACTIVE_NOT_RECRUITING	Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
NCT05493761	PHASE4	ACTIVE_NOT_RECRUITING	Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease
NCT05666310	PHASE4	ACTIVE_NOT_RECRUITING	Muscle Impact of Treating Osteoporosis
NCT05966064	PHASE4	RECRUITING	DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)
NCT06118905	PHASE4	RECRUITING	Preserving Geriatric Muscle With an Osteoporosis Medication
NCT06332014	PHASE4	ACTIVE_NOT_RECRUITING	Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
NCT06643780	PHASE4	RECRUITING	RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
NCT06720350	PHASE4	NOT_YET_RECRUITING	Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
NCT07271771	PHASE4	RECRUITING	The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
NCT07281586	PHASE4	RECRUITING	Step-down Therapy After Long-term Osteoporosis Treatment
NCT07283887	PHASE4	RECRUITING	Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
NCT01465568	PHASE4	COMPLETED	Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
NCT01558115	PHASE4	TERMINATED	Denosumab in Primary Hyperparathyroidism
NCT01732770	PHASE4	COMPLETED	Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
NCT01734824	PHASE4	SUSPENDED	Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
NCT01750086	PHASE4	COMPLETED	Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
NCT01753856	PHASE4	COMPLETED	Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
NCT01770106	PHASE4	COMPLETED	RA Denosumab on Bone Microstructure Study
NCT01983475	PHASE4	UNKNOWN	Denosumab Administration After Spinal Cord Injury
NCT02101164	PHASE4	WITHDRAWN	Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease
NCT02156960	PHASE4	UNKNOWN	Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
NCT02176382	PHASE4	COMPLETED	Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
NCT02499237	PHASE4	COMPLETED	Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation
NCT02721433	PHASE4	COMPLETED	4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases
NCT02753283	PHASE4	COMPLETED	Preventing Osteoporosis Using Denosumab
NCT02760979	PHASE4	COMPLETED	The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
NCT02792413	PHASE4	TERMINATED	Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
NCT02853539	PHASE4	COMPLETED	Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
NCT03005678	PHASE4	COMPLETED	Denosumab Versus Bisphosphonates (Alendronate) in GIOP
NCT03029442	PHASE4	TERMINATED	The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
NCT03301857	PHASE4	COMPLETED	Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
NCT03868033	PHASE4	COMPLETED	Denosumab Sequential Therapy
NCT04026256	PHASE4	COMPLETED	Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
NCT04085419	PHASE4	UNKNOWN	Osteoporosis in Primary Hyperparathyroidism

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).