Fosamax

(Alendronate)

ApprovedSmall molecule

OOrganon and Co

Fosamax is one of 281 small molecule programs targeting Osteoporosis. It is currently in Approved.

Indications

Total Trials

Active Trials

280

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

OsteoporosisEnrolling by invitation

Esophageal CancerActive, not recruiting

Ankylosing SpondylitisActive, not recruiting

Renal OsteodystrophyActive, not recruiting

Low Back PainActive, not recruiting

Bone ResorptionActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

ACL ReconstructionRecruiting

HIVRecruiting

Cervical CancerNot yet recruiting

OsteoporosisApproved

Enrolling by invitation

Esophageal CancerPreclinical

Active, not recruiting

Ankylosing SpondylitisPreclinical

Active, not recruiting

Renal OsteodystrophyPreclinical

Active, not recruiting

Low Back PainApproved

Active, not recruiting

Bone ResorptionApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Active, not recruiting

ACL ReconstructionApproved

Recruiting

HIVPhase 2

Recruiting

Cervical CancerPhase 2

Not yet recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Fosamax

OOrganon and Co

Approved

1 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Osteonecrosis

NCT07471880

Q2 2027

Phase 2Recruiting

HIV

NCT07216794

Phase 2Not yet recruiting

Bone Density

NCT06973109

Q3 2028

ApprovedRecruiting

ACL Reconstruction

NCT05527548

Q3 2029

Post-ApprovalRecruiting

Osteoporosis

NCT06864130

Clinical

Trials by Indication[1]

Osteoporosis32 trials

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

Terminated·NNycomed·Phase 4·NCT00713258·75 enrolled

A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche··NCT01128257·6,054 enrolled

Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Completed·—·N/A·NCT00936260·228 enrolled

Show 29 more trials

Stem Cell Recruitment in Osteoporosis Therapy

Terminated·JJohns Hopkins University·N/A·NCT01656629·55 enrolled

PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

Completed·DDennis Black·Phase 2·NCT00005005·238 enrolled

Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

Recruiting·MMadhumathi Rao·Phase 4·NCT05151484·60 enrolled

To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk

Completed·SShenzhen Salubris Pharmaceuticals Co., Ltd.·Phase 3·NCT07028320·493 enrolled

Effects of Parathyroid Hormone in Men With Osteoporosis

Completed·MMassachusetts General Hospital·Phase 3·NCT00000427·81 enrolled

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Completed· Roche logo

Roche·Phase 4·NCT00503113·801 enrolled

Alendronate and/or Parathyroid Hormone for Osteoporosis

Completed·MMassachusetts General Hospital·Phase 2·NCT00000400·176 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

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis

Completed·MMedical University of South Carolina·Phase 2·NCT00259857·22 enrolled

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche·Phase 4·NCT02598440·341 enrolled

Osteoporosis Treatment in Post-menopausal Women

Unknown status·TTaichung Veterans General Hospital·Phase 4·NCT03006003·500 enrolled

A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

Terminated· GSK logo

GSK·Phase 2·NCT00471237·564 enrolled

Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

Completed·MMedical University of South Carolina·Phase 2·NCT00010439·10 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

Osteoporosis and Dental Implant

Unknown status·—·Phase 4·NCT00727493·45 enrolled

Alendronate in Juvenile Osteoporosis

Completed·MMedical University of South Carolina··NCT00920075·11 enrolled

Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

Completed· Novartis logo

Novartis·Phase 3·NCT00404820·604 enrolled

A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women With Osteoporosis After a Treatment Period Without Fractures

Recruiting·OOdense University Hospital·Phase 4·NCT06864130·1,400 enrolled

Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )

Terminated·CCanadian Urology Research Consortium·Phase 3·NCT00236002·182 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

Osteoporosis Prevention With Low Dose Alendronate

Completed·UUniversity Hospital of Mont-Godinne·Phase 3·NCT00463268·83 enrolled

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Completed·RRadius Health, Inc.·Phase 3·NCT01657162·1,139 enrolled

Precision Medicine Approach for Osteoporosis - Follow Up Study

Enrolling by invitation·PPaul F Netzel·Phase 4·NCT06264609·40 enrolled

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Completed· Amgen logo

Amgen·Phase 3·NCT01631214·4,093 enrolled

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

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

Unknown status·UUniversity of Messina·Phase 2/3·NCT03040531·200 enrolled

Evaluation Of Missed Osteoporosis Diagnoses, And Preference Between Once Monthly Ibandronate And Once Weekly Alendronate

Completed· GSK logo

GSK·Phase 4·NCT00327990·300 enrolled

Low Bone Mineral Density4 trials

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

Completed· Amgen logo

Amgen·Phase 2·NCT00293813·247 enrolled

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00043186·412 enrolled

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

Completed· Amgen logo

Amgen·Phase 3·NCT00330460·1,189 enrolled

Show 1 more trial

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Completed· Amgen logo

Amgen·Phase 2·NCT00896532·419 enrolled

Bone4 trials

The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover

Completed·UUniversity Hospital, Ghent·Phase 2·NCT04403698·30 enrolled

Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket

Completed·IIslamic Azad University, Sanandaj·Phase 2·NCT03980847·20 enrolled

RA Denosumab on Bone Microstructure Study

Completed·—·Phase 4·NCT01770106·40 enrolled

Show 1 more trial

Cyclic Versus Daily Teriparatide on Bone Mass

Unknown status·—·Phase 2·NCT00668941·140 enrolled

Prevention2 trials

Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss

Terminated·UUniversity College Dublin·Phase 4·NCT02322099·53 enrolled

Bisphosphonates for Prevention of Post-Denosumab Bone Loss

Completed·—·Phase 2·NCT03396315·24 enrolled

Effectiveness2 trials

Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT02139007·27 enrolled

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00921557·52 enrolled

43 more indications

Postmenopausal Women2 trials

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 3·NCT01552122

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss

Completed·EEulji University Hospital·Phase 4·NCT00460057·63 enrolled

Osteogenesis Imperfecta2 trials

Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta

Completed·PPeking Union Medical College Hospital·Phase 4·NCT02303873·99 enrolled

Bisphosphonate Therapy for Osteogenesis Imperfecta

Completed·IIndiana University School of Medicine·Phase 4·NCT00159419·18 enrolled

Treatment2 trials

Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy

Terminated·EEvangelisches Krankenhaus Lutherhaus gGmbH·Phase 3·NCT01512446·436 enrolled

Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Active, not recruiting·NNanfang Hospital, Southern Medical University··NCT03692143·90 enrolled

Prostate Cancer2 trials

Prevention of Osteoporosis in Men With Prostate Cancer

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00048841·112 enrolled

Prevention of Osteoporosis in Men With Prostate Cancer on Androgen Deprivation Therapy (POP Study)

Completed·UUniversity of Pittsburgh·Phase 3·NCT00177619·120 enrolled

Osteonecrosis2 trials

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

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

Calcification2 trials

Alendronate for Vascular Calcification in Peritoneal Dialysis Patients?

Unknown status·FFar Eastern Memorial Hospital·Phase 4·NCT00299572·50 enrolled

Can Alendronate Suppress Calcification and Improve Bone Density in Chronic Peritoneal Dialysis Patients?

Completed·NNational Taiwan University Hospital·Phase 4·NCT00261625·50 enrolled

Primary Hyperparathyroidism2 trials

The Effects of Alendronate After Cure of Primary Hyperparathyroidism

Withdrawn·—·Phase 4·NCT00359385

Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism

Completed·IIstituto Auxologico Italiano·Phase 4·NCT02417389·22 enrolled

Cystic Fibrosis2 trials

Treatment of Low Bone Density in Cystic Fibrosis.

Completed·IIstituto Auxologico Italiano·Phase 3·NCT01812551·171 enrolled

Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients

Completed·MMcMaster University·Phase 4·NCT00157690·56 enrolled

Postmenopausal Osteoporosis2 trials

Texture Analysis for Postmenopausal Osteoporosis

Completed·UUniversity of Chicago·N/A·NCT00145977·36 enrolled

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

Completed·OOrganon and Co·Phase 3·NCT00092014·1,053 enrolled

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

Bone Disease1 trial

A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00480662·60 enrolled

Trial1 trial

The Forteo Alendronate Comparator Trial

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT02416271·203 enrolled

Ankylosing Spondylitis1 trial

Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

Completed·GGöteborg University··NCT01104987·16 enrolled

Chronic1 trial

Romosozumab in Women With Chronic SCI

Completed·NNorthwestern University·Phase 2·NCT04708886·12 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

Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Completed·WWarner Chilcott·Phase 1·NCT00577850·32 enrolled

Completed·MMassachusetts General Hospital·Phase 1·NCT02057263·28 enrolled

Menopausal Women1 trial

Bone Loss in Premenopausal Women With Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00006180·220 enrolled

Breast Cancer1 trial

Pilot Study of Bisphosphonates for Breast Cancer

Terminated·UUniversity of Wisconsin, Madison·Phase 1·NCT02781805·6 enrolled

Satisfaction1 trial

Denosumab Adherence Preference Satisfaction Study

Completed· Amgen logo

Amgen·Phase 3·NCT00518531·250 enrolled

Efficacy1 trial

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT03623633·51 enrolled

Interaction1 trial

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06772792·36 enrolled

Bone Density1 trial

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes

Not yet recruiting·NNitin Agarwal·Phase 2·NCT06973109·36 enrolled

Cervical Cancer1 trial

Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemoradiation

Not yet recruiting·—·Phase 1/2·NCT07245381·65 enrolled

Transplantation1 trial

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

Completed·—·Phase 2/3·NCT00297830·111 enrolled

Vertebroplasty1 trial

Denosumab vs Alendronate After Vertebroplasty

Unknown status·SShenzhen People's Hospital·N/A·NCT05662358·90 enrolled

Bone Resorption1 trial

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Completed·MMassachusetts General Hospital·Phase 4·NCT01750086·27 enrolled

Esophageal Cancer1 trial

Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)

Completed·OOrganon and Co··NCT01077817·684,815 enrolled

Low back pain1 trial

Efficacy and Safety of Minodronate in Patients With Low Back Pain

Unknown status·PPeking University Third Hospital·Phase 4·NCT05645289·72 enrolled

Rheumatoid Arthritis1 trial

Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

Completed·UUniversity of Aarhus·Phase 2·NCT02944799·69 enrolled

Glucocorticoids1 trial

Glucocorticoids Promote Osteoclast Survival

Terminated·UUniversity of Arkansas··NCT00572299·3 enrolled

Bone Loss1 trial

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Completed·UUniversity of Nebraska·N/A·NCT00580047·59 enrolled

Testosterone1 trial

Testosterone and Alendronate in Hypogonadal Men

Terminated·MMassachusetts General Hospital·Phase 2·NCT01460654·44 enrolled

Renal Osteodystrophy1 trial

Renal Osteodystrophy: An Individual Management Approach

Completed·—·N/A·NCT02440581·141 enrolled

Asthma1 trial

Alendronate to Prevent Loss of Bronchoprotection in Asthma

Completed·MMilton S. Hershey Medical Center·Phase 2/3·NCT02230332·78 enrolled

Spinal Cord Injury1 trial

Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide

Completed·NNorthwestern University·Phase 2·NCT02195895·17 enrolled

Chronic Kidney Disease1 trial

Study of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease

Completed·MMonash University·Phase 4·NCT00395382·50 enrolled

Childhood Cancer1 trial

Fosamax for Childhood Cancer Survivors

Unknown status·—·Phase 3·NCT00391404·100 enrolled

HIV1 trial

Small Trial of Alendronate Impact on the Reservoir of HIV

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07216794·30 enrolled

ACL Reconstruction1 trial

The Effect of Oral Administration of Alendronate on Knee Functions Following Anterior Cruciate Ligament Reconstruction - A Multi-Centre, Double-Blind, Placebo-Controlled, Randomized Trial

Recruiting·CChinese University of Hong Kong·Approved·NCT05527548·100 enrolled

Unspecified2 trials

Study of Transitioning From Alendronate to Denosumab

Completed· Amgen logo

Amgen·Phase 3·NCT00377819·504 enrolled

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Completed·TTuen Mun Hospital·Phase 4·NCT03005678·140 enrolled

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]
ClinicalTrials.gov — 98 trial records for Alendronate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Alendronate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Alendronate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202344). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fosamax. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

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

Fosamax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2028

Q3 2029

Trials by Indication[1]

Osteoporosis32 trials

Low Bone Mineral Density4 trials

Bone4 trials

Prevention2 trials

Effectiveness2 trials

Postmenopausal Women2 trials

Osteogenesis Imperfecta2 trials

Treatment2 trials

Prostate Cancer2 trials

Osteonecrosis2 trials

Calcification2 trials

Primary Hyperparathyroidism2 trials

Cystic Fibrosis2 trials

Postmenopausal Osteoporosis2 trials

Chronic Periodontitis2 trials

Bone Disease1 trial

Trial1 trial

Ankylosing Spondylitis1 trial

Chronic1 trial

Vitamin D1 trial

Oral1 trial

TIA1 trial

Hip Fracture1 trial

Hepatitis B1 trial

Menopausal Women1 trial

Breast Cancer1 trial

Satisfaction1 trial

Efficacy1 trial

Interaction1 trial

Bone Density1 trial

Cervical Cancer1 trial

Transplantation1 trial

Vertebroplasty1 trial

Bone Resorption1 trial

Esophageal Cancer1 trial

Low back pain1 trial

Rheumatoid Arthritis1 trial

Glucocorticoids1 trial

Bone Loss1 trial

Testosterone1 trial

Renal Osteodystrophy1 trial

Asthma1 trial

Spinal Cord Injury1 trial

Chronic Kidney Disease1 trial

Childhood Cancer1 trial

HIV1 trial

ACL Reconstruction1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News