Fosamax
(Alendronate)ApprovedSmall molecule
Fosamax is one of 547 small molecule programs targeting Childhood Cancer. It is currently in Approved.
25
Indications
98
Total Trials
9
Active Trials
546
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
1
Patents
Pipeline
Status by Indication[3][1]
Indication
Showing 10 of 25 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Fosamax
OOrganon and Co
Approved
MS Contin
Merck & Co.Preclinical
Spravato
WWim Janssens
Preclinical
Effexor
WWyeth-Lederle Vaccines
Preclinical
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Preclinical
Aquasol E
NNational Eye Institute (NEI)
Preclinical
Zoladex
Luye Pharma Group Ltd.Preclinical
Neoadjuvant Treatment
SShanghai Zhongshan Hospital
Preclinical
Vit D
PPost Graduate Institute of Medical Education and Research, Chandigarh
Preclinical
Perflutren Lipid Microcpheres
TThomas Jefferson University
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Osteoporosis32 trials
Show 29 more trials
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00120757·140 enrolled
Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Completed·—·Phase 2·NCT00005006·140 enrolled
Osteoporosis Prevention After Heart Transplant
Completed·—·Phase 3·NCT00000412·149 enrolled
Alendronate Osteoporosis Study
Completed·—·Phase 2/3·NCT00277251·20 enrolled
Treatment of Childhood Osteoporosis With Alendronate (Fosamax)
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001720·50 enrolled
Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Terminated·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 3·NCT00000430·240 enrolled
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Completed·—·N/A·NCT00936260·228 enrolled
Osteoporosis and Dental Implant
Unknown status·—·Phase 4·NCT00727493·45 enrolled
Low Bone Mineral Density4 trials
Bone4 trials
Cyclic Versus Daily Teriparatide on Bone Mass
Unknown status·—·Phase 2·NCT00668941·140 enrolled
RA Denosumab on Bone Microstructure Study
Completed·—·Phase 4·NCT01770106·40 enrolled
Show 1 more trial
Osteogenesis Imperfecta2 trials
Chronic Periodontitis2 trials
1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
Completed·GGovernment Dental College and Research Institute, Bangalore·Phase 2·NCT02168543·46 enrolled
Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis
Completed·GGovernment Dental College and Research Institute, Bangalore·Phase 2/3·NCT03204097·90 enrolled
42 more indications
Postmenopausal Osteoporosis2 trials
Effectiveness2 trials
Prostate Cancer2 trials
Primary Hyperparathyroidism2 trials
Prevention2 trials
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
Completed·—·Phase 2·NCT03396315·24 enrolled
Postmenopausal Women2 trials
Osteonecrosis2 trials
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Unknown status·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 4·NCT00265252·60 enrolled
A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head
Active, not recruiting·ZZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.·Phase 2·NCT07471880·161 enrolled
Trial2 trials
Small Trial of Alendronate Impact on the Reservoir of HIV
Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07216794·30 enrolled
Cystic Fibrosis2 trials
Calcification2 trials
Chronic Kidney Disease1 trial
Childhood Cancer1 trial
Fosamax for Childhood Cancer Survivors
Unknown status·—·Phase 3·NCT00391404·100 enrolled
Esophageal Cancer1 trial
Spinal Cord Injury1 trial
Ankylosing Spondylitis1 trial
Bone Loss1 trial
Transplantation1 trial
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Completed·—·Phase 2/3·NCT00297830·111 enrolled
Hepatitis B1 trial
Renal Osteodystrophy1 trial
Renal Osteodystrophy: An Individual Management Approach
Completed·—·N/A·NCT02440581·141 enrolled
Vitamin D1 trial
The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00061256·80 enrolled
Oral1 trial
Hip Fracture1 trial
The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT00346190·10 enrolled
Bone Disease1 trial
Interaction1 trial
Cervical Cancer1 trial
Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemoradiation
Not yet recruiting·—·Phase 1/2·NCT07245381·65 enrolled
Function1 trial
A Single-blind RCT to Investigate the Effect of Alendronate on Knee Function Following ACLR
Unknown status·—·Phase 4·NCT05527548·64 enrolled
Bone Resorption1 trial
Regulatory
FDA Approval Timeline[4]
Apr 25, 1997
FOSAMAX
NDA NDA020560
Sep 17, 2003
FOSAMAX
NDA NDA021575
Mar 12, 2012
BINOSTO
NDA NDA202344
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Alendronate. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[2]
- Highest Phase
- Approved[1]
- Company
- OOrganon and Co
Patent Landscape[5]
Patent Cliff
Dec 5, 2031
Earliest patent expiration — generic entry possible after this date
Patent #Expires
9592195Dec 5, 2031