Fosamax

(Alendronate Sodium)

ApprovedSmall molecule

Fosamax is a small molecule that works as a Farnesyl Diphosphate Synthase Inhibitor.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Fosamax is one of 162 small molecule programs targeting Metabolic Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

161

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Metabolic DiseaseUnknown

Postmenopausal OsteoporosisUnknown

Osteitis DeformansUnknown

Alcoholic Fatty Liver DiseaseActive, not recruiting

Chronic PeriodontitisActive, not recruiting

Cystic FibrosisActive, not recruiting

Nonalcoholic Fatty LiverCompleted

OsteoporosisUnknown status

Sickle Cell DiseaseRecruiting

Metabolic DiseasePreclinical

Unknown

Postmenopausal OsteoporosisPreclinical

Unknown

Osteitis DeformansPreclinical

Unknown

Alcoholic Fatty Liver DiseaseApproved

Active, not recruiting

Chronic PeriodontitisApproved

Active, not recruiting

Cystic FibrosisPreclinical

Active, not recruiting

Nonalcoholic Fatty LiverApproved

Completed

OsteoporosisPhase 3

Unknown status

Sickle Cell DiseasePhase 2

Recruiting

Competition

Competitive Landscape

107 competitors in Cystic Fibrosis

#DrugCompanyPhaseTrials

Fosamax

OOrganon and Co

Approved

1 2

Ibsrela

AArdelyx

Phase 3

1 3

Biaxin

AbbVie

Phase 2

2 4

HSK31858

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

2 5

Tygacil

PPrism Pharmaceuticals

Phase 2

1 6

Sirturo

WWim Janssens

Phase 2

1 7

ELX/TEZ/IVA

Vertex Pharmaceuticals

Phase 3

18 8

Trikafta

NNottingham University Hospitals NHS Trust

Phase 3

4 9

VNZ/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

1 10

VX-121/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Post-ApprovalActive, not recruiting

Chronic Periodontitis

NCT06856369

Q4 2027

Phase 2Recruiting

Sickle Cell Disease

NCT06016634

Q4 2030

Phase 3Recruiting

Osteoporosis

NCT04704947

Clinical

Trials by Indication[1]

Osteoporosis5 trials

Network Osteoporosis Study

Unknown status·GGlaser Pediatric Research Network·Phase 2/3·NCT00209469·90 enrolled

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00051558·428 enrolled

Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis

Unknown status·SShanghai JMT-Bio Inc.·Phase 2·NCT05397938·231 enrolled

Show 2 more trials

MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00996801·526 enrolled

Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT04704947·50 enrolled

Fasting Conditions2 trials

Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01133496·80 enrolled

Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.

Completed· Teva logo

Teva·Phase 1·NCT00835406·140 enrolled

OSA2 trials

Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT01012934·110 enrolled

Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00983996·112 enrolled

Trial1 trial

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Completed·BBarwon Health·Phase 3·NCT00122356·303 enrolled

Surgical1 trial

Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects.

Completed·PPanineeya Mahavidyalaya Institute of Dental Sciences & Research Centre·Phase 4·NCT02795546·32 enrolled

8 more indications

Cystic Fibrosis1 trial

Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

Completed·UUniversity of North Carolina·N/A·NCT00004489·60 enrolled

Osteopenia1 trial

Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

Completed·—·Phase 2·NCT00004488·82 enrolled

Postmenopausal Women1 trial

Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women

Completed·UUniversity of California, San Francisco·Phase 4·NCT00504166·53 enrolled

Breast Cancer1 trial

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00354302·497 enrolled

Chronic Periodontitis1 trial

Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis

Active, not recruiting·—·Phase 4·NCT06856369·120 enrolled

Metastatic Prostate Cancer1 trial

Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00019695

Nonalcoholic Fatty Liver1 trial

Effect of Anti-osteoporotic Medications on Hepatic Steatosis and Fibrosis of Women With Postmenopausal Osteoporosis and Nonalcoholic Fatty Liver Disease

Completed·AAristotle University Of Thessaloniki·Approved·NCT05493761·72 enrolled

Sickle Cell Disease1 trial

A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease

Recruiting·UUniversity of California, Davis·Phase 2·NCT06016634·30 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 — 19 trial records for Alendronate Sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Alendronate Sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Alendronate Sodium. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202344). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Farnesyl Diphosphate Synthase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: OOrganon and Co

Fosamax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q4 2030

Trials by Indication[1]

Osteoporosis5 trials

Fasting Conditions2 trials

OSA2 trials

Trial1 trial

Surgical1 trial

Cystic Fibrosis1 trial

Osteopenia1 trial

Postmenopausal Women1 trial

Breast Cancer1 trial

Chronic Periodontitis1 trial

Metastatic Prostate Cancer1 trial

Nonalcoholic Fatty Liver1 trial

Sickle Cell Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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