Alendronate Sodium

ApprovedSmall molecule

Alendronate Sodium is a small molecule that works as a Farnesyl Diphosphate Synthase Inhibitor.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Alendronate Sodium is one of 277 small molecule programs targeting Vitamin D Deficiency. It is currently in Approved.

Indications

Total Trials

Active Trials

276

Competitors

Pipeline

Status by Indication[3][1]

Indication

Vitamin D DeficiencyActive, not recruiting

OsteopeniaActive, not recruiting

Alcoholic Fatty Liver DiseaseActive, not recruiting

Metabolic DiseaseUnknown

Postmenopausal OsteoporosisUnknown

Metastatic Prostate CancerActive, not recruiting

Chronic PeriodontitisActive, not recruiting

Breast CancerActive, not recruiting

Cystic FibrosisActive, not recruiting

Sickle Cell DiseaseActive, not recruiting

Vitamin D DeficiencyPhase 3

Active, not recruiting

OsteopeniaPhase 2

Active, not recruiting

Alcoholic Fatty Liver DiseaseApproved

Active, not recruiting

Metabolic DiseasePreclinical

Unknown

Postmenopausal OsteoporosisPreclinical

Unknown

Metastatic Prostate CancerPhase 2

Active, not recruiting

Chronic PeriodontitisApproved

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Cystic FibrosisPreclinical

Active, not recruiting

Sickle Cell DiseasePhase 2

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Alendronate Sodium

Mylan Pharmaceuticals Inc

Approved

1 2

Tykerb

GSK

Preclinical

80 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

DATROWAY

Daiichi Sankyo

Preclinical

4 5

Lexiscan

Astellas

Preclinical

1 6

Adenocard

Astellas

Preclinical

1 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 9

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Alcoholic Fatty Liver Disease

NCT05493761

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

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00051558·428 enrolled

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

Network Osteoporosis Study

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

Show 2 more trials

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

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

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

Completed· Teva logo

Teva·Phase 1·NCT00835406·140 enrolled

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

Completed·—·Phase 1·NCT01133496·80 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

Alcoholic Fatty Liver Disease1 trial

Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease

Active, not recruiting·—·Phase 4·NCT05493761·72 enrolled

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

8 more indications

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

Trial1 trial

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

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

Osteopenia1 trial

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

Completed·—·Phase 2·NCT00004488·82 enrolled

Sickle Cell Disease1 trial

Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

Recruiting·UUniversity of California, Davis·Phase 2·NCT06016634·30 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

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

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

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

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]
SEC EDGAR — Mylan Pharmaceuticals Inc 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: Mylan Pharmaceuticals Inc

Alendronate Sodium

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q3 2027

Q4 2027

Q4 2030

Trials by Indication[1]

Osteoporosis5 trials

Fasting Conditions2 trials

OSA2 trials

Alcoholic Fatty Liver Disease1 trial

Cystic Fibrosis1 trial

Postmenopausal Women1 trial

Trial1 trial

Osteopenia1 trial

Sickle Cell Disease1 trial

Chronic Periodontitis1 trial

Surgical1 trial

Metastatic Prostate Cancer1 trial

Breast Cancer1 trial

References

Drug Info

Quick Facts

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