> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f > Record changed: 2026-10-13 # Denosumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) First approval year 2010 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) ## Development status **First approval year** 2010 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) **Drug name** Denosumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) ### Brand names (12) - jubbonti - Jubbonti - prolia - Prolia - prolia ranmark xgeva - prolia xgeva - Prolia, ranmark xgeva - Prolia, xgeva - wyost - Wyost - xgeva - Xgeva ### Other names (172) - 100 mg amg 162 - 100 mg AMG 162 - 14 mg AMG 162 - 60 mg AMG 162 - 60 mg denosumab - 9mw 0311 - 9mw 0321 - 9MW-0311 - 9MW-0321 - amg 162 - AMG 162 - AMG-162 - amg162 - AMG162 - aukelso - AUKELSO - bildyos - BILDYOS - bilprevda - BILPREVDA - bomyntra - BOMYNTRA - boncresa - BONCRESA - bosaya And 147 more, listed on the interactive page. ## Identifiers **ATC classification codes** - M05BX04 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) **CAS registry numbers** - 615258-40-7 **ChEMBL ID** CHEMBL1237023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1237023) **FDA ingredient codes (UNII)** - 4EQZ6YO2HI ### RxNorm IDs (RxCUI) (2) - 993449 - 2715382 ## Regulatory information ### United States **Applicant** AMGEN **Approval date** 1 Jun 2010 **Application number** BLA125320 ### European Union **Status** Authorised **Status date** 26 May 2010 **Authorisation date** 26 May 2010 **Approved indications** Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures. **Product number** EMEA/H/C/001120 **Authorisation holder** Amgen Europe B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 28 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Bone Resorption - Osteoporosis - Osteoporosis, Postmenopausal European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/prolia) ### Other regulatory facts **Patents** 0 **Designations** 1 **Earliest recorded loss of exclusivity** 29 Oct 2025 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** denosumab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **Action** Binding **Action type** Binding **Target** RANK ligand **Gene symbol** RANK ligand **Median affinity** 9.64 **Affinity units** pIC50 **Primary target** Yes - **Mechanism** Tumor necrosis factor ligand superfamily member 11 inhibitor **Action type** Inhibitor **Target** Tumor necrosis factor ligand superfamily member 11 **Protein identifier** O14788 ### Open Targets mechanisms - **Mechanism** Tumor necrosis factor ligand superfamily member 11 inhibitor **Action type** Inhibitor **Target** Tumor necrosis factor ligand superfamily member 11 ### Investigated indications (43) - **Condition** Aortic Valve Stenosis **Highest recorded phase** 2 **Condition identifier** EFO:0000266 **Subject identifier** D001024 - **Condition** Breast Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000305 **Subject identifier** D001943 - **Condition** Carcinoma **Highest recorded phase** 3 **Condition identifier** EFO:0000313 **Subject identifier** D002277 - **Condition** Crohn Disease **Highest recorded phase** 1 **Condition identifier** EFO:0000384 **Subject identifier** D003424 - **Condition** Melanoma **Highest recorded phase** 2 **Condition identifier** EFO:0000389 **Subject identifier** D008545 - **Condition** Diabetes Mellitus **Highest recorded phase** 3 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Osteosarcoma **Highest recorded phase** 2 **Condition identifier** EFO:0000637 **Subject identifier** D012516 - **Condition** Carcinoma, Renal Cell **Highest recorded phase** 3 **Condition identifier** EFO:0000681 **Subject identifier** D002292 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 3 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Melanoma **Highest recorded phase** 2 **Condition identifier** EFO:0000756 **Subject identifier** D008545 - **Condition** Ovarian Neoplasms **Highest recorded phase** 0.5 **Condition identifier** EFO:0001075 **Subject identifier** D010051 - **Condition** Multiple Myeloma **Highest recorded phase** 2 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 2 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Neoplasms, Bone Tissue **Highest recorded phase** 4 **Condition identifier** EFO:0003820 **Subject identifier** D018213 - **Condition** Osteoporosis, Postmenopausal **Highest recorded phase** 4 **Condition identifier** EFO:0003854 **Subject identifier** D015663 - **Condition** Breast Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0003869 **Subject identifier** D001943 - **Condition** Osteoporosis **Highest recorded phase** 4 **Condition identifier** EFO:0003882 **Subject identifier** D010024 - **Condition** Fractures, Bone **Highest recorded phase** 3 **Condition identifier** EFO:0003931 **Subject identifier** D050723 - **Condition** Infertility, Male **Highest recorded phase** 2 **Condition identifier** EFO:0004248 **Subject identifier** D007248 - **Condition** Bone Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0004260 **Subject identifier** D001847 - **Condition** Gout **Highest recorded phase** 2 **Condition identifier** EFO:0004274 **Subject identifier** D006073 - **Condition** Giant Cell Tumor of Bone **Highest recorded phase** 4 **Condition identifier** EFO:0007176 **Subject identifier** D018212 - **Condition** Neoplasm Metastasis **Highest recorded phase** 4 **Condition identifier** EFO:0009708 **Subject identifier** D009362 And 18 more, listed on the interactive page. ### Open Targets indications (90) - **Condition identifier** EFO\_0000266 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000305 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000384 - **Condition identifier** EFO\_0000389 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000400 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000637 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000681 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000685 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000756 **Highest recorded phase** 2 - **Condition identifier** EFO\_0001075 - **Condition identifier** EFO\_0001378 - **Condition identifier** EFO\_0003060 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003820 - **Condition identifier** EFO\_0003854 - **Condition identifier** EFO\_0003869 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003882 - **Condition identifier** EFO\_0003931 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004248 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004260 - **Condition identifier** EFO\_0004274 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004616 - **Condition identifier** EFO\_0007176 - **Condition identifier** EFO\_0009708 And 65 more, listed on the interactive page. ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events (25) - **Event** arthralgia **Reports** 3,283 **Reporting signal score** 1,711.07 - **Event** atypical femur fracture **Reports** 513 **Reporting signal score** 1,308.75 - **Event** back pain **Reports** 2,455 **Reporting signal score** 1,826.45 - **Event** blood calcium decreased **Reports** 508 **Reporting signal score** 828.102 - **Event** blood parathyroid hormone increased **Reports** 309 **Reporting signal score** 683.161 - **Event** bone density abnormal **Reports** 375 **Reporting signal score** 1,183.51 - **Event** bone density decreased **Reports** 502 **Reporting signal score** 1,076.96 - **Event** bone pain **Reports** 1,689 **Reporting signal score** 2,463.1 - **Event** fracture **Reports** 592 **Reporting signal score** 830.099 - **Event** hypocalcaemia **Reports** 1,765 **Reporting signal score** 3,677.2 - **Event** jaw disorder **Reports** 331 **Reporting signal score** 615.027 - **Event** lumbar vertebral fracture **Reports** 305 **Reporting signal score** 661.646 - **Event** musculoskeletal pain **Reports** 890 **Reporting signal score** 729.65 - **Event** myalgia **Reports** 1,775 **Reporting signal score** 1,000.6 - **Event** osteonecrosis of jaw **Reports** 5,511 **Reporting signal score** 15,226.9 - **Event** pain in extremity **Reports** 2,730 **Reporting signal score** 1,703.39 - **Event** pain in jaw **Reports** 1,263 **Reporting signal score** 2,119.98 - **Event** rebound effect **Reports** 335 **Reporting signal score** 653.335 - **Event** spinal fracture **Reports** 1,327 **Reporting signal score** 3,079.93 - **Event** terminal state **Reports** 355 **Reporting signal score** 838.84 - **Event** thoracic vertebral fracture **Reports** 311 **Reporting signal score** 744.913 - **Event** tooth disorder **Reports** 1,476 **Reporting signal score** 3,039.47 - **Event** tooth extraction **Reports** 831 **Reporting signal score** 1,712.16 - **Event** tooth fracture **Reports** 492 **Reporting signal score** 904.911 - **Event** toothache **Reports** 564 **Reporting signal score** 828.644 ### Trial references (125) - NCT00089661 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00089661) - NCT00330460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00330460) - NCT00089674 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00089674) - NCT00286091 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00286091) - NCT00838201 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00838201) - NCT01824342 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01824342) - NCT02758132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02758132) - NCT00089791 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00089791) - NCT00306189 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00306189) - NCT00518531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00518531) - NCT00680953 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00680953) - NCT00919711 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00919711) - NCT00926380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00926380) - NCT01377467 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01377467) - NCT01465568 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01465568) - NCT01732770 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01732770) - NCT01753856 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01753856) - NCT02049866 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02049866) - NCT02135640 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02135640) - NCT02156960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02156960) - NCT02632916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02632916) - NCT02753283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02753283) - NCT03005678 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03005678) - NCT03164928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03164928) - NCT03242512 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03242512) And 100 more, listed on the interactive page. ## Dosing **Dose** 60 mg **Route** Subcutaneous **How often** Every 6 months ### Conditions of use (5) - Do not re-cap syringe after use - Do not use if solution is discolored, cloudy, or contains particles - Do not warm in any other way - Inspect for particulate matter and discoloration prior to administration - Remove from refrigerator and bring to room temperature up to 25°C (77°F) by standing for 15-30 minutes ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 0143-9165 - 0143-9166 - 55513-710 - 55513-730 - 61314-228 - 61314-240 - 65219-668 - 65219-670 - 65219-672 - 69448-021 - 69448-022 - 72606-037 - 72606-038 - 72606-058 - 72606-059 - 78206-193 - 78206-195 - 83257-029 - 83257-030 - 83457-012 - 70121-2701 - 70121-2702 ## Related records ### Trials (284) - 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases - A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches - A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® - A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis - A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab - A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density - A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density - A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection - A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis - A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® - A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects - A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density. - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects - A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone - A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. - [A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva](https://trialight.com/data/trial/a-study-comparing-the-pharmacokinetic-similarity-of-mb09-and-24ea61a5-9188-47c7-97e2-c8785c96d0d6.md) - A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status - A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China - A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab - A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab ### Approved for (11) - [Bone disorder](https://trialight.com/data/condition/bone-disorder-83c4c003-c8df-50f7-8829-fbbb5d5adf76.md) - Bone giant cell tumor - Bone neoplasm - Bone resorption disease - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - Breast carcinoma - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - Giant cell tumor - Hypercalcemia disease - Osteoporosis - Postmenopausal osteoporosis ### In development for (31) - Allergic disease Phase 2 - Anorexia nervosa Phase 3 - [Aortic valve stenosis](https://trialight.com/data/condition/aortic-valve-stenosis-d3f1a482-d908-5993-8a6c-7daad057bb89.md) Phase 2 - Bone fracture Phase 3 - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) Phase 3 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2 - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 1 - [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) Phase 2 - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Phase 3 - Fibrous dysplasia Phase 2 - [Gout](https://trialight.com/data/condition/gout-b61aaf55-4a3b-56d9-966a-ca77100d2fc5.md) Phase 2 - Inflammatory breast carcinoma Phase 2 - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1 - Langerhans cell histiocytosis Phase 2 - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 3 - Lytic metastatic bone lesion Phase 2 - Male infertility Phase 2 - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 2 - Metabolic bone disorder Phase 3 - Neoplasm Phase 2 ### Other linked conditions (2) - [Osteoarthritis, knee](https://trialight.com/data/condition/osteoarthritis-knee-217c801b-d59c-514b-92dd-3abbf23b24d7.md) - Type 1 diabetes mellitus ### Targets (1) - [TNFSF11](https://trialight.com/data/target/tnfsf11-f943913e-58f0-5f3e-b943-025022f2eab3.md) Tumor necrosis factor ligand superfamily member 11 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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