Denosumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2010
- First approval year
- 2010
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Denosumab
- jubbonti
- Jubbonti
- prolia
- Prolia
- prolia ranmark xgeva
- prolia xgeva
- Prolia, ranmark xgeva
- Prolia, xgeva
- wyost
- Wyost
- xgeva
- Xgeva
- 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.
- ATC classification codes
- M05BX04
Sources for recorded values
- CAS registry numbers
- 615258-40-7
- ChEMBL ID
- CHEMBL1237023
- FDA ingredient codes (UNII)
- 4EQZ6YO2HI
- 993449
- 2715382
- Applicant
- AMGEN
- Approval date
- 1 Jun 2010
- Application number
- BLA125320
- 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
- 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 name
- denosumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- 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.
- 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
- 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
- NCT00089661
- NCT00330460
- NCT00089674
- NCT00286091
- NCT00838201
- NCT01824342
- NCT02758132
- NCT00089791
- NCT00306189
- NCT00518531
- NCT00680953
- NCT00919711
- NCT00926380
- NCT01377467
- NCT01465568
- NCT01732770
- NCT01753856
- NCT02049866
- NCT02135640
- NCT02156960
- NCT02632916
- NCT02753283
- NCT03005678
- NCT03164928
- NCT03242512
And 100 more, listed on the interactive page.
- Dose
- 60 mg
- Route
- Subcutaneous
- How often
- Every 6 months
- 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
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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
- 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
- Bone giant cell tumor
- Bone neoplasm
- Bone resorption disease
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Giant cell tumor
- Hypercalcemia disease
- Osteoporosis
- Postmenopausal osteoporosis
In development for (31)
- Allergic disease Phase 2
- Anorexia nervosa Phase 3
- Aortic valve stenosis Phase 2
- Bone fracture Phase 3
- Carcinoma Phase 3
- Colorectal cancer Phase 2
- Crohn disease Phase 1
- Cutaneous melanoma Phase 2
- Diabetes mellitus Phase 3
- Fibrous dysplasia Phase 2
- Gout Phase 2
- Inflammatory breast carcinoma Phase 2
- Kidney disorder Phase 1
- Langerhans cell histiocytosis Phase 2
- Lung cancer Phase 3
- Lytic metastatic bone lesion Phase 2
- Male infertility Phase 2
- Melanoma Phase 2
- Metabolic bone disorder Phase 3
- Neoplasm Phase 2
Other linked conditions (2)
- Osteoarthritis, knee
- Type 1 diabetes mellitus
Targets (1)
- TNFSF11 Tumor necrosis factor ligand superfamily member 11 inhibitor