Aredia

(Pamidronate)

ApprovedSmall molecule

HHikma Pharmaceuticals LLC

Aredia is one of 152 small molecule programs targeting Bone Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

151

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Bone DiseaseActive, not recruiting

Osteogenesis ImperfectaActive, not recruiting

Total Hip ArthroplastyNot yet recruiting

OsteomyelitisActive, not recruiting

Breast CancerCompleted

PreventionCompleted

Heterotopic OssificationWithdrawn

SpondyloarthropathyActive, not recruiting

Renal OsteodystrophyCompleted

Bone DiseasePreclinical

Active, not recruiting

Osteogenesis ImperfectaApproved

Active, not recruiting

Total Hip ArthroplastyPhase 1

Not yet recruiting

OsteomyelitisPreclinical

Active, not recruiting

Breast CancerApproved

Completed

PreventionPreclinical

Completed

Heterotopic OssificationPreclinical

Withdrawn

SpondyloarthropathyApproved

Active, not recruiting

Renal OsteodystrophyApproved

Completed

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Aredia

HHikma Pharmaceuticals LLC

Approved

2 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Spravato

WWim Janssens

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

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

Timeline

Expected Milestones

Q3 2050

Recruiting

Osteomyelitis

NCT04725422

Clinical

Trials by Indication[1]

Osteogenesis Imperfecta2 trials

Bisphosphonate Therapy for Osteogenesis Imperfecta

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

Pamidronate to Treat Osteogenesis Imperfecta in Children

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00005901·34 enrolled

Multiple Myeloma2 trials

Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month

Completed·NNordic Myeloma Study Group·Phase 3·NCT00376883·500 enrolled

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

Completed·MMayo Clinic·Phase 1/2·NCT00482378·39 enrolled

Breast Cancer2 trials

The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer

Completed·OOttawa Hospital Research Institute·Phase 4·NCT01907880·74 enrolled

Pamidronate Administration in Breast Cancer Patients With Bone Metastases

Completed·SSpanish Breast Cancer Research Group·Phase 4·NCT00128297·152 enrolled

Low back pain2 trials

A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT00101790·44 enrolled

A Pilot Trial of IV Pamidronate for Low Back Pain

Completed·—·Phase 1/2·NCT01210599·44 enrolled

Bone Disease2 trials

Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease

Withdrawn· Amgen logo

Amgen·Phase 4·NCT02101164

Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation

Completed·PProvidence Health & Services·N/A·NCT00302627·43 enrolled

13 more indications

Angiogenesis2 trials

Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Completed·UUniversity of Arkansas·Phase 2·NCT00083408·20 enrolled

Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Completed·UUniversity of Arkansas·Phase 2·NCT00083382·83 enrolled

Bone Metastases1 trial

4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

Completed·OOttawa Hospital Research Institute·Phase 4·NCT02721433·263 enrolled

Osteomyelitis1 trial

CHronic Nonbacterial Osteomyelitis International Registry

Recruiting·SSeattle Children's Hospital··NCT04725422·2,000 enrolled

Treatment1 trial

Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression

Unknown status·—·Phase 4·NCT02313727·30 enrolled

Osteoporosis1 trial

Prevention of Steroid-Induced Osteoporosis in Children

Terminated·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 1/2·NCT00022841·40 enrolled

Spondyloarthropathy1 trial

Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial

Completed·TTuen Mun Hospital·Phase 4·NCT01718951·30 enrolled

Heterotopic Ossification1 trial

Study of Pamidronate for the Prevention of Heterotopic Ossification

Withdrawn·UUniversity Hospital, Basel, Switzerland·N/A·NCT00262392

Renal Osteodystrophy1 trial

Osteopenia and Renal Osteodystrophy: Evaluation and Management

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00108394

Renal Transplant1 trial

A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.

Completed· Novartis logo

Novartis·Phase 4·NCT00738257·126 enrolled

Back pain1 trial

Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT01799616·48 enrolled

Total Hip Arthroplasty1 trial

Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty

Not yet recruiting·GGeneral and Teaching Hospital Celje·Phase 1·NCT00548288·40 enrolled

Prevention1 trial

Prevention of Post Operative Bone Loss in Children

Completed·UUniversity of New Mexico·N/A·NCT00655681·24 enrolled

Hematopoietic Cell Transplantation1 trial

Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT02074631·63 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 31, 1991

AREDIA

NDA NDA020036

Mar 4, 2002

PAMIDRONATE DISODIUM

NDA NDA021113

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Pamidronate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pamidronate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pamidronate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021113). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: HHikma Pharmaceuticals LLC

Aredia

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2050

Trials by Indication[1]

Osteogenesis Imperfecta2 trials

Multiple Myeloma2 trials

Breast Cancer2 trials

Low back pain2 trials

Bone Disease2 trials

Angiogenesis2 trials

Bone Metastases1 trial

Osteomyelitis1 trial

Treatment1 trial

Osteoporosis1 trial

Spondyloarthropathy1 trial

Heterotopic Ossification1 trial

Renal Osteodystrophy1 trial

Renal Transplant1 trial

Back pain1 trial

Total Hip Arthroplasty1 trial

Prevention1 trial

Hematopoietic Cell Transplantation1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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