Boniva

(Ibandronate)

ApprovedSmall molecule

CConrado Roberto Hoffmann Filho

Boniva is one of 276 small molecule programs targeting Osteonecrosis. It is currently in Approved.

Indications

Total Trials

Active Trials

275

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

OsteonecrosisActive, not recruiting

Bone DiseaseActive, not recruiting

OsteopeniaActive, not recruiting

Lung CancerActive, not recruiting

Bone DensityActive, not recruiting

Esophageal CancerActive, not recruiting

Postmenopausal OsteoporosisActive, not recruiting

Bone Marrow TransplantationActive, not recruiting

Breast CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

OsteonecrosisPhase 3

Active, not recruiting

Bone DiseaseApproved

Active, not recruiting

OsteopeniaPhase 3

Active, not recruiting

Lung CancerApproved

Active, not recruiting

Bone DensityPhase 2

Active, not recruiting

Esophageal CancerPreclinical

Active, not recruiting

Postmenopausal OsteoporosisApproved

Active, not recruiting

Bone Marrow TransplantationPhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Multiple MyelomaPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Boniva

CConrado Roberto Hoffmann Filho

Approved

6 2

Trodelvy

Gilead

Preclinical

37 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

MS Contin

Merck & Co.

Preclinical

2 5

Spravato

WWim Janssens

Preclinical

2 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Chirocaine

PPurdue Pharma LP

Preclinical

1 8

Nubain

AAultman Health Foundation

Preclinical

1 9

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 10

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

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

Clinical

Trials by Indication[1]

Osteoporosis26 trials

A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Completed· Roche logo

Roche·Phase 4·NCT02604836·1,711 enrolled

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

Completed· Roche logo

Roche·Phase 4·NCT02598440·341 enrolled

A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

Completed· Roche logo

Roche·Phase 4·NCT00148915·98 enrolled

Show 23 more trials

The Effect Of Oral Ibandronate In Male Osteoporosis

Completed· Roche logo

Roche·Phase 3·NCT00397839·135 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

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Completed· Roche logo

Roche·Phase 4·NCT00081653·719 enrolled

ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Completed· Roche logo

Roche·Phase 4·NCT00545090·561 enrolled

BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.

Completed· Roche logo

Roche·Phase 3·NCT00493623·68 enrolled

A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche·Phase 3·NCT01290094·41 enrolled

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Completed· Roche logo

Roche·Phase 4·NCT00551174·781 enrolled

A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

No longer available· Roche logo

Roche··NCT00493532

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Completed· Roche logo

Roche·Phase 4·NCT00377234·356 enrolled

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche·Phase 4·NCT00545909·585 enrolled

MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche·Phase 3·NCT00048061·1,609 enrolled

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

Completed· Roche logo

Roche··NCT01128257·6,054 enrolled

A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

Completed· Roche logo

Roche·Phase 4·NCT00303485·67 enrolled

DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

Completed· Roche logo

Roche·Phase 3·NCT00048074·1,395 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

SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

Completed· Roche logo

Roche·Phase 4·NCT00545480·596 enrolled

PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

Completed· Roche logo

Roche·Phase 4·NCT02598453·545 enrolled

A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Completed· Roche logo

Roche·Phase 4·NCT00545051·140 enrolled

A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)

Completed· Roche logo

Roche·Phase 4·NCT00545363·716 enrolled

BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Completed· Roche logo

Roche·Phase 3·NCT00545779·677 enrolled

Efficacy of Oral Ibandronate in Osteoporosis

Unknown status·SShinshu University·Phase 2·NCT03186131·100 enrolled

Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

Withdrawn·GGermans Trias i Pujol Hospital·Phase 4·NCT00662077

Study of Investigational Drug in Osteoporosis (MK-0217-908)

Completed·OOrganon and Co·Phase 3·NCT00092053·203 enrolled

Breast Cancer6 trials

A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

Completed· Roche logo

Roche·Phase 3·NCT02716792·334 enrolled

A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

Withdrawn· Roche logo

Roche·Phase 2·NCT00478270

A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

Completed· Roche logo

Roche·Phase 2·NCT00502736·13 enrolled

Show 3 more trials

Study in Elderly Patients With Early Breast Cancer (ICE)

Completed·GGBG Forschungs GmbH·Phase 3·NCT00196859·1,500 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

A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

Completed· Roche logo

Roche·Phase 4·NCT02553707·182 enrolled

Bone Disease4 trials

A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Completed· Roche logo

Roche·Phase 3·NCT02561039·97 enrolled

A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Terminated· Roche logo

Roche·Phase 3·NCT00099203·163 enrolled

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Terminated· Roche logo

Roche·Phase 3·NCT00099177·96 enrolled

Show 1 more trial

A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease

Completed· Roche logo

Roche·Phase 4·NCT02564107·48 enrolled

Postmenopausal Osteoporosis2 trials

A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

Completed· Roche logo

Roche·Phase 4·NCT02598934·308 enrolled

Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

Completed· GSK logo

GSK·Phase 4·NCT00405392·365 enrolled

Osteopenia2 trials

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

Completed· Roche logo

Roche·Phase 4·NCT00129623·160 enrolled

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

Completed· Roche logo

Roche·Phase 3·NCT00545207·150 enrolled

14 more indications

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

Osteonecrosis1 trial

Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis

Terminated·—·Phase 3·NCT02114489·8 enrolled

Efficacy1 trial

Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

Completed·YYeong-Wook Song·Phase 4·NCT01287533·167 enrolled

Multiple Myeloma1 trial

Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

Terminated· Roche logo

Roche·Phase 3·NCT02739594·89 enrolled

TIA1 trial

Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT00666627·410 enrolled

Cirrhosis1 trial

Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06022237·80 enrolled

Bone Density1 trial

Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

Completed·—·Phase 2·NCT04321837·60 enrolled

Lung Cancer1 trial

Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

Terminated·CChinese Society of Lung Cancer·Phase 4·NCT00492843·20 enrolled

Bone Marrow Transplantation1 trial

Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00824993·78 enrolled

Postmenopausal Women1 trial

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

Completed· Amgen logo

Amgen·Phase 3·NCT00936897·833 enrolled

Oral1 trial

A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

Completed· GSK logo

GSK·Phase 4·NCT02948881·100 enrolled

Renal Transplantation1 trial

Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.

Unknown status·SSmerud Medical Research International AS·Phase 2/3·NCT00423384·130 enrolled

Low Bone Mineral Density1 trial

The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density

Terminated·PPapageorgiou General Hospital·Phase 4·NCT00446589·19 enrolled

Unspecified3 trials

Use of Ibandronate in Diabetic Patients

Completed·YYeouido St. Mary's Hospital·N/A·NCT05266261·121 enrolled

BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Completed· GSK logo

GSK··NCT01381393·659 enrolled

PTH & Ibandronate Combination Study (PICS)

Completed·UUniversity of California, San Francisco·Phase 2/3·NCT00683163·44 enrolled

Regulatory

FDA Approval Timeline[4]

May 16, 2003

BONIVA

NDA NDA021455

Jan 6, 2006

BONIVA

NDA NDA021858

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Ibandronate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ibandronate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ibandronate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021858). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

Boniva

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Osteoporosis26 trials

Breast Cancer6 trials

Bone Disease4 trials

Postmenopausal Osteoporosis2 trials

Osteopenia2 trials

Esophageal Cancer1 trial

Osteonecrosis1 trial

Efficacy1 trial

Multiple Myeloma1 trial

TIA1 trial

Cirrhosis1 trial

Bone Density1 trial

Lung Cancer1 trial

Bone Marrow Transplantation1 trial

Postmenopausal Women1 trial

Oral1 trial

Renal Transplantation1 trial

Low Bone Mineral Density1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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