Zoledronate

Phase 3Small molecule

Mario Negri Institute for Pharmacological Research

Zoledronate is one of 155 small molecule programs targeting Treatment. It is currently in Phase 3.

Indications

Total Trials

Active Trials

154

Competitors

Pipeline

Status by Indication[3][1]

Indication

TreatmentTerminated

Liver TransplantActive, not recruiting

Stem Cell TransplantationRecruiting

Hematologic MalignanciesRecruiting

OsteoporosisRecruiting

TreatmentPreclinical

Terminated

Liver TransplantPreclinical

Active, not recruiting

Stem Cell TransplantationPhase 1

Recruiting

Hematologic MalignanciesPhase 1

Recruiting

OsteoporosisPhase 3

Recruiting

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Zoledronate

Mario Negri Institute for Pharmacological Research

Phase 3

2 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Lotemax

PPharmos

Preclinical

1 8

Norpramin

VValidus Pharmaceuticals

Preclinical

1 9

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 10

Sirturo

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalActive, not recruiting

Osteoporosis

NCT05655013

Q4 2027

Phase 1Recruiting

Hematologic Malignancies

NCT02508038

Recruiting

Osteoporosis, Postmenopausal

NCT06164795

Q4 2028

Phase 1Recruiting

Stem Cell Transplantation

NCT07375290

Post-ApprovalRecruiting

Osteoporosis

NCT07281586

Q3 2032

ApprovedRecruiting

Osteoporosis

NCT06059222

Clinical

Trials by Indication[1]

Breast Cancer4 trials

Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT03358017·54 enrolled

Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00213980·68 enrolled

S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone

Withdrawn·SSWOG Cancer Research Network·Phase 3·NCT00301886

Show 1 more trial

Pre-operative Zoledronate in Triple Negative Breast Cancer

Terminated· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT02347163·22 enrolled

Osteoporosis3 trials

Step-down Therapy After Long-term Osteoporosis Treatment

Recruiting·NNational Taiwan University Hospital·Phase 4·NCT07281586·44 enrolled

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

Active, not recruiting·—·Phase 4·NCT05655013·200 enrolled

The Optimised Use of Romozosumab Study

Recruiting·UUniversity of Aarhus·Approved·NCT06059222·270 enrolled

Treatment2 trials

The Optimal Sequential Therapy After Long Term Denosumab Treatment

Completed·NNational Taiwan University Hospital·Phase 4·NCT05091099·44 enrolled

Bone Loss Treatment From Adjuvant Zoledronate Efficacy

Terminated·FFirst Affiliated Hospital, Sun Yat-Sen University·N/A·NCT01623908·200 enrolled

Cervical Intraepithelial Neoplasia1 trial

Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3

Terminated·UUniversity of California, San Francisco·Phase 1·NCT00278434·12 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

11 more indications

Vertebroplasty1 trial

Denosumab vs Zoledronate After Vertebroplasty

Completed·SShenzhen People's Hospital·Phase 4·NCT05598606·75 enrolled

Multiple Myeloma1 trial

Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

Terminated· Roche logo

Roche·Phase 3·NCT02739594·89 enrolled

Liver Transplant1 trial

Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Unknown status·MMedical University of Vienna·N/A·NCT00302484·96 enrolled

Adult1 trial

Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

Unknown status·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00102908·30 enrolled

Hip Fracture1 trial

The Effect of Zoledronate on the Prevention of Pneumonia in Hip Fracture Patients

Unknown status·TThe University of Hong Kong·Phase 4·NCT05743179·2,692 enrolled

Hematologic Malignancies1 trial

Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT02508038·22 enrolled

Renal Cell Carcinoma1 trial

Zoledronate With Atorvastatin in Renal Cell Carcinoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00490698·11 enrolled

Stem Cell Transplantation1 trial

Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Phase 1·NCT07375290·20 enrolled

Osteoporosis, Postmenopausal1 trial

Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study

Recruiting·4424 General Military Hospital··NCT06164795·150 enrolled

Early-stage Breast Cancer1 trial

A Randomised, Multicentre, Pragmatic Trial Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)

Completed·OOttawa Hospital Research Institute·Approved·NCT03664687·211 enrolled

Unspecified1 trial

Denosumab vs Zoledronate After Lumbar Fusion

Unknown status·SShenzhen People's Hospital·Phase 3·NCT05638399·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Zoledronate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zoledronate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zoledronate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Mario Negri Institute for Pharmacological Research company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Mario Negri Institute for Pharmacological Research

Zoledronate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q4 2028

Q3 2032

Trials by Indication[1]

Breast Cancer4 trials

Osteoporosis3 trials

Treatment2 trials

Cervical Intraepithelial Neoplasia1 trial

Bone Metastases1 trial

Vertebroplasty1 trial

Multiple Myeloma1 trial

Liver Transplant1 trial

Adult1 trial

Hip Fracture1 trial

Hematologic Malignancies1 trial

Renal Cell Carcinoma1 trial

Stem Cell Transplantation1 trial

Osteoporosis, Postmenopausal1 trial

Early-stage Breast Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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