Zoledronic acid
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2001
- First approval year
- 2001
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Zoledronic acid
- Molecular weight
- 290.11
- Structure (SMILES)
- O.O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
- aclasta
- Aclasta
- reclast
- Reclast
- zerlinda
- Zerlinda
- zoledronic acid
- Zoledronic acid
- zoledronic acid accord
- Zoledronic acid accord
- zoledronic acid actavis
- Zoledronic acid actavis
- zoledronic acid hospira
- Zoledronic acid hospira
- zoledronic acid medac
- Zoledronic acid medac
- zoledronic acid mylan
- Zoledronic acid mylan
- zoledronic acid teva
- Zoledronic acid teva
- zoledronic acid teva generics
- Zoledronic acid teva generics
- zoledronic acid teva pharma
- Zoledronic acid teva pharma
- zometa
And 1 more, listed on the interactive page.
- acide zoledronique
- Acide zoledronique
- Acide Zoledronique
- acido zoledronico
- Acido zoledronico
- Aclasta
- ak 156
- AK-156
- cgp 42446
- CGP 42446
- cgp 42446a
- CGP-42446
- CGP-42446A
- Intravenous zoledronic acid
- IV Zometa
- nsc 721517
- NSC-721517
- phosphonic acid 1 hydroxy 2 1h imidazol 1 yl ethylidene bis monohydrate
- PHOSPHONIC ACID, (1-HYDROXY-2-(1H-IMIDAZOL-1-YL)ETHYLIDENE)BIS-, MONOHYDRATE
- zoladrona acid mylan
- Zoladrona acid mylan
- Zolderonic acid (Zometa)
- zoledronate hydrate
- Zoledronate hydrate
- zoledronic
And 55 more, listed on the interactive page.
- ATC classification codes
- M05BA08
Sources for recorded values
- ChEMBL ID
- CHEMBL4303669
- InChIKey
- FUXFIVRTGHOMSO-UHFFFAOYSA-N
- PubChem compound IDs
- 121586
- RxNorm IDs (RxCUI)
- 77655
- FDA ingredient codes (UNII)
- 6XC1PAD3KF
- 118072-93-8
- 165800-06-6
- Applicant
- SANDOZ
- Approval date
- 16 Apr 2007
- Application number
- NDA021817
- Status
- Authorised
- Status date
- 20 Mar 2001
- Authorisation date
- 20 Mar 2001
- Approved indications
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH).
- Product number
- EMEA/H/C/000336
- Authorisation holder
- Phoenix Labs Unlimited Company
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 3
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Cancer
- Fractures, Bone
European medicines record
- Patents
- 3
- Designations
- 2
- Earliest recorded loss of exclusivity
- 5 Aug 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- zoledronic acid
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- farnesyl diphosphate synthase
- Gene symbol
- FDPS
- Protein identifier
- P14324
- Median affinity
- 6.32
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Farnesyl diphosphate synthase inhibitor
- Action type
- Inhibitor
- Target
- Farnesyl pyrophosphate synthase
- Protein identifier
- P14324
Open Targets mechanisms
- Mechanism
- Farnesyl diphosphate synthase inhibitor
- Action type
- Inhibitor
- Target
- Farnesyl pyrophosphate synthase
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- FDPS
- Protein identifier
- P14324
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Adenocarcinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Chondrosarcoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000333
- Subject identifier
- D002813
- Condition
- Carcinoma, Intraductal, Noninfiltrating
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000432
- Subject identifier
- D002285
- Condition
- Leiomyosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000564
- Subject identifier
- D007890
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neuroblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Osteosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sarcoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Macular Degeneration
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Multiple Myeloma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001416
- Subject identifier
- D002583
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002430
- Subject identifier
- D055728
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Bone Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003820
- Subject identifier
- D001859
- Condition
- Pain
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Osteoporosis, Postmenopausal
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003854
- Subject identifier
- D015663
And 32 more, listed on the interactive page.
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000200
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000333
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000564
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_0001416
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001663
- Condition identifier
- EFO_0002430
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003854
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003882
- Condition identifier
- EFO_0003931
- Condition identifier
- EFO_0004252
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004259
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004260
And 75 more, listed on the interactive page.
- Event
- abscess jaw
- Reports
- 123
- Reporting signal score
- 361.554
- Event
- actinomycosis
- Reports
- 173
- Reporting signal score
- 558.404
- Event
- arthralgia
- Reports
- 1,765
- Reporting signal score
- 909.328
- Event
- aseptic necrosis bone
- Reports
- 322
- Reporting signal score
- 1,234.79
- Event
- atypical femur fracture
- Reports
- 199
- Reporting signal score
- 443.159
- Event
- bone debridement
- Reports
- 189
- Reporting signal score
- 727.615
- Event
- bone disorder
- Reports
- 1,515
- Reporting signal score
- 4,478.5
- Event
- bone lesion
- Reports
- 353
- Reporting signal score
- 1,041.72
- Event
- bone pain
- Reports
- 1,019
- Reporting signal score
- 1,587.26
- Event
- chills
- Reports
- 710
- Reporting signal score
- 452.386
- Event
- debridement
- Reports
- 125
- Reporting signal score
- 399.451
- Event
- dental operation
- Reports
- 147
- Reporting signal score
- 406.193
- Event
- dental treatment
- Reports
- 119
- Reporting signal score
- 477.898
- Event
- femur fracture
- Reports
- 469
- Reporting signal score
- 637.275
- Event
- fistula
- Reports
- 347
- Reporting signal score
- 686.127
- Event
- gingival infection
- Reports
- 139
- Reporting signal score
- 457.257
- Event
- gingival swelling
- Reports
- 270
- Reporting signal score
- 709.519
- Event
- gingivitis
- Reports
- 272
- Reporting signal score
- 609.125
- Event
- hypocalcaemia
- Reports
- 550
- Reporting signal score
- 857.065
- Event
- impaired healing
- Reports
- 852
- Reporting signal score
- 1,640.74
- Event
- influenza like illness
- Reports
- 932
- Reporting signal score
- 1,115.13
- Event
- jaw disorder
- Reports
- 437
- Reporting signal score
- 1,187.36
- Event
- jaw operation
- Reports
- 175
- Reporting signal score
- 605.925
- Event
- loose tooth
- Reports
- 172
- Reporting signal score
- 432.598
- Event
- malignant neoplasm progression
- Reports
- 544
- Reporting signal score
- 406.587
And 26 more, listed on the interactive page.
- NCT00003884
- NCT00099177
- NCT00099203
- NCT00365105
- NCT00375648
- NCT00219258
- NCT00237159
- NCT00241111
- NCT00372710
- NCT00375427
- NCT00022087
- NCT00046254
- NCT00049452
- NCT00049829
- NCT00050011
- NCT00058188
- NCT00097812
- NCT00097825
- NCT00100555
- NCT00100620
- NCT00107263
- NCT00145327
- NCT00329797
- NCT00332709
- NCT00404820
And 139 more, listed on the interactive page.
- Dose
- 5 mg
- Route
- Intravenous
- How often
- Once a year
- Administered as a single infusion
- Administered over no less than 15 minutes
- Followed by a 10 mL normal saline flush
- Infusion time must not be less than 15 minutes given over a constant infusion rate
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 5
- Polar surface area
- 153.11
- Calculated partition coefficient (ALogP)
- -1.12
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 17
- Molecular formula
- C5H12N2O8P2
- Monoisotopic mass
- 290.00688934
- Natural product
- No
- 0143-9642
- 16729-242
- 23155-170
- 25021-826
- 25021-830
- 43598-233
- 43598-255
- 43598-330
- 43598-331
- 54288-100
- 54288-183
- 55111-685
- 55111-688
- 55150-266
- 55150-283
- 63323-961
- 63323-966
- 66758-155
- 67457-390
- 67457-619
- 67457-794
- 68001-437
- 68001-610
- 68001-611
- 68083-116
And 10 more, listed on the interactive page.
- Recorded assays
- 281
- Active assays
- 72
Active assay types
- Confirmatory
Related records
Trials (317)
- 1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
- 3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
- A Clinical Trial to Evaluate Efficacy of Once or Twice ZOledronic Acid After Different Duration of denOsumMab Administration in Postmenopausal Women With Osteoporosis (ZOOM Study)
- A Multiple Myeloma Trial in Patients With Bone Metastases
- A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
- A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
- A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
- A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
- A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
- A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
- A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
- A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
- A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
- A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
- A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
- A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors
- A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
- A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)
- A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years
- A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)
Approved for (12)
- Bone disorder
- Bone fracture
- Bone Paget disease
- Hypercalcemia disease
- Metastatic prostate carcinoma
- Osteoporosis
- Paget disease
- Plasma cell myeloma
- Postmenopausal osteoporosis
- Prostate adenocarcinoma
- Prostate cancer
- Prostate carcinoma
In development for (39)
- Adenocarcinoma Phase 1
- Age-related macular degeneration Phase 2
- Beta thalassemia Phase 2
- Bone neoplasm Phase 3
- Bone resorption disease Phase 2
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Cervical adenocarcinoma Phase 2
- Chondrosarcoma Phase 1
- Complex regional pain syndrome Phase 2
- Ductal breast carcinoma in situ Phase 2
- Ewing sarcoma Phase 3
- Exocrine pancreatic carcinoma Phase 2
- Giant cell tumor Phase 3
- Hepatocellular carcinoma Phase 3
- HIV infectious disease Phase 2
- Hutchinson-Gilford progeria syndrome Phase 2
- Kidney cancer Phase 2
- Leiomyosarcoma Phase 2
- Lung cancer Phase 3
Other linked conditions (2)
Targets (1)
- FDPS Farnesyl diphosphate synthase inhibitor