Zometa
(Zoledronic acid)ApprovedSmall molecule
PfizerZoledronic acid is used to treat bone loss and prevent bone fractures in patients with osteoporosis, and to manage bone problems caused by cancer and high calcium levels in the blood.[2] Zometa is currently approved and in use across 71 indications[4].[1]
Zometa is one of 1312 small molecule programs targeting Paget disease. It is currently in Approved.
71
Indications
261
Total Trials
13
Active Trials
1,311
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 70 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Zometa
PfizerApproved
Tecentriq
RochePreclinical
Trodelvy
GileadPreclinical
Adriamycin
GGynecologic Oncology Group
Preclinical
Gemzar
GGynecologic Oncology Group
Preclinical
Lexiscan
AstellasPreclinical
Adenocard
AstellasPreclinical
Chirocaine
PPurdue Pharma LP
Preclinical
Vfend
PPrism Pharmaceuticals
Preclinical
Motexafin Gadolinium
PPharmacyclics LLC.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Breast Cancer26 trials
Show 23 more trials
Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
Terminated·—·N/A·NCT01409811·9 enrolled
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
Completed·—·Phase 2·NCT00903162·17 enrolled
Prostate Cancer21 trials
Show 18 more trials
Multiple Myeloma18 trials
Show 15 more trials
Osteoporosis12 trials
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Completed·—·Phase 4·NCT03087851·61 enrolled
Show 9 more trials
Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities
Completed·—··NCT03301285·60 enrolled
Bone Metastasis9 trials
Show 6 more trials
71 more indications
Non-Small Cell Lung Cancer7 trials
Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
Terminated·—·Phase 2·NCT01004510·3 enrolled
Osteogenesis Imperfecta6 trials
Show 3 more trials
Metastatic Prostate Cancer4 trials
Spinal Cord Injury4 trials
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Terminated·—·Phase 2·NCT00844480·17 enrolled
Show 1 more trial
Prevention3 trials
Osteosarcoma3 trials
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT03932071·150 enrolled
Bone Loss3 trials
Postmenopausal Osteoporosis3 trials
Paget's Disease of Bone3 trials
Osteonecrosis3 trials
Mononuclear Cells, Platelets and Zoledronic Acid for Preventing Collapse of the Femoral Head in Osteonecrosis
Unknown status·—·N/A·NCT02721940·100 enrolled
Triple-Negative Breast Cancer2 trials
Low Bone Mineral Density2 trials
Treatment2 trials
Bariatric Surgery2 trials
Osteopenia2 trials
Bone Metastases2 trials
Safety and Efficacy2 trials
Osteoarthritis2 trials
Bone Disease2 trials
Postmenopausal Women2 trials
Efficacy2 trials
Femur Fracture1 trial
Pancreatic Cancer1 trial
Malignant Solid Tumors1 trial
Amenorrhea1 trial
Diabetes Mellitus1 trial
Progeria1 trial
A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
Completed·—·Phase 2·NCT00879034·5 enrolled
Physical Activity1 trial
Patients With Solid Tumors1 trial
Neuroblastoma1 trial
Transplantation1 trial
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Completed·—·Phase 2/3·NCT00297830·111 enrolled
Liver Transplant1 trial
The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients
Completed·—·Phase 4·NCT00114556·100 enrolled
Total Hip Arthroplasty1 trial
Thalassemia1 trial
Bone Resorption1 trial
Relapsed or Refractory1 trial
Pancreas Cancer1 trial
Fracture1 trial
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Completed·—··NCT04736693·18,028 enrolled
Efficacy and Safety1 trial
Cervical Cancer1 trial
Anemia1 trial
Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic Anemia
Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT07471516·2 enrolled
Double-blind1 trial
Hip Fracture1 trial
Long Term Efficacy and Safety1 trial
Myelofibrosis1 trial
Lumbar Degenerative Disease1 trial
Giant Cell Tumor1 trial
Interleukin1 trial
Surgery1 trial
Chondrosarcoma1 trial
Idiopathic Inflammatory Myopathies1 trial
Intravenous1 trial
Knee Injury1 trial
Tics1 trial
Primary Hyperparathyroidism1 trial
Unspecified4 trials
Regulatory
FDA Approval Timeline[5]
Aug 20, 2001
ZOMETA
NDA NDA021223
Apr 16, 2007
RECLAST
NDA NDA021817
Aug 2, 2013
ZOLEDRONIC ACID
NDA NDA203231
Dec 28, 2015
ZOLEDRONIC ACID
NDA NDA204016
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Zometa drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Zoledronic acid. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Zometa. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Patent Landscape[6]
Patent Cliff
Feb 5, 2028
Earliest patent expiration — generic entry possible after this date