ibandronate

Trade name: boniva

Small moleculeapproved

Approved

May 16, 2003

Ibandronic acid (INN) or ibandronate sodium (USAN) is a potent bisphosphonate drug developed by Hoffman La Roche and used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer. Ibandronate is indicated for the treatment and prevention of osteoporosis in post-menopausal women. In May 2003, the U.S. Food and Drug Administration (FDA) approved Ibandronate as a daily treatment for post-menopausal osteoporosis. The basis for this approval was a three-year, randomized, double-blind, placebo-controlled trial women with post-menopausal osteoporosis. Every participant also received daily oral doses of calcium and 400IUs [international units] of vitamin D. At the study's conclusion, both doses significantly reduced the occurrence risk of new vertebral fractures by 50–52 percent when compared to the effects of the placebo drug. Ibandronate is efficacious for the prevention of metastasis-related bone fractures in multiple myeloma, breast cancer, and certain other cancers. In 2008, the U.S Food and Drug Administration (FDA) issued a communication warning of the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain.[4] A study conducted by the American Society of Bone and Mineral Research concluded that long-term use of bisphosphonates, including Boniva, may increase the risk of a rare but serious fracture of the femur. Ibandronic acid is marketed under the trade names Boniva in the USA, Bondronat in Europe, Bonviva in Asia, Ibandrix in Ecuador and Bondrova in Bangladesh. — NCATS

Clinical trial activity

68 trials · 57 clinical orgs · 21 marketing orgs

Phase 1
2
Phase 2
32
Phase 3
27
Phase 4
28

Earliest trial started Apr 1, 2002 (NCT00048061)

Timeline

2000s

  1. Jan 1, 2002

    Roche — Earliest Phase 3 Sponsor(trial)

  2. May 16, 2003

    Roche — Earliest FDA Approval

  3. May 16, 2003

    Roche — NDA Organization

  4. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  5. Jan 6, 2006

    Roche — Marketing Organization

  6. Jan 1, 2008

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  7. Apr 3, 2009

    Teva — Marketing Organization

2010s

  1. Mar 15, 2011

    Cobalt Labs Inc — Marketing Organization

  2. Mar 15, 2011

    GlaxoSmithKline — Marketing Organization

  3. Mar 19, 2012

    Apotex — Marketing Organization

  4. Mar 19, 2012

    Orchid Pharma — Marketing Organization

  5. Mar 19, 2012

    Orbion Pharms — Marketing Organization

  6. Mar 19, 2012

    Mylan — Marketing Organization

  7. Mar 19, 2012

    PHARMOBEDIENT — Marketing Organization

  8. Apr 30, 2012

    Dr. Reddy's Laboratories — Marketing Organization

  9. Feb 14, 2014

    Sun Pharmaceuticals — Marketing Organization

  10. Sep 2, 2014

    Emcure — Marketing Organization

  11. Sep 2, 2014

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  12. Sep 2, 2014

    Avet Lifesciences — Marketing Organization

  13. Sep 2, 2014

    Chemi SpA — Marketing Organization

  14. Aug 19, 2015

    Aurobindo Pharma — Marketing Organization

  15. Aug 19, 2015

    Eugia Pharma — Marketing Organization

  16. Feb 5, 2016

    Accord Research — Marketing Organization

  17. Oct 31, 2017

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  18. Oct 31, 2017

    Neogen — Marketing Organization

2020s

  1. Jun 16, 2021

    Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedMay 16, 2003

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCN(C)CCC(O)(P(=O)([O-])O)P(=O)(O)O.O.[Na+]
Mol. weight
359.23 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • (1-hydroxy-3-(methylpentylamino)propylidene)bisphosphonate
  • 1-hydroxy-3-(methylpentylamino)propylidenebisphosphonate
  • bm 210955
  • bm 21.0955
  • bm 21.0955
  • bm 21.0955
  • bm-210955
  • bm-21.0955
  • bm-21.0955
  • bm-21.0955
  • bondronat
  • bondronat
  • bondronat
  • boniva
  • boniva
  • boniva
  • boniva
  • boniva
  • bonvia
  • bonviva
  • bonviva
  • bonviva
  • bonviva
  • bonviva
  • bonviva
  • iasibon
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate
  • ibandronate sodium
  • ibandronate sodium
  • ibandronate sodium
  • ibandronate sodium
  • ibandronate sodium
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid
  • ibandronic acid, sodium salt, monohydrate
  • quodixor
  • rpr 102289a
  • rpr-102289a

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07242612N/AOct 1, 2025Khyber Medical University Peshawar
NCT06022237N/ASep 1, 2023Institute of Liver and Biliary Sciences, India
NCT04321837Phase 2Feb 5, 2020Columbia University, Osteoporosis Center of Armenia, University of California, Irvine
NCT05266261N/AOct 1, 2018Catholic University of Korea, Seoul National University, Sungkyunkwan University
NCT03186131Phase 2Jun 14, 2017Shinshu University
NCT02114489Phase 3Jun 1, 2014University of Lausanne
NCT02249741Phase 4Aug 1, 2012Sir Ganga Ram Hospital
NCT01581320Phase 3Dec 1, 2011Alvogen, Catholic University of Korea
NCT01429675Phase 1Aug 1, 2011Alvogen, University of Ulsan
NCT01290094Phase 3Apr 1, 2011Roche
NCT02616744Phase 2Jan 1, 2011University of Florence
NCT01287533Phase 4Apr 1, 2010Seoul National University
NCT00936897Phase 3Jul 1, 2009Amgen
NCT00824993Phase 3Dec 9, 2008Roche, University of Texas at Houston
NCT01627886Phase 1Sep 1, 2008BA Research India Ltd, Dr. Reddy's Laboratories
NCT00683163Phase 2/Phase 3 (Phase 3)May 1, 2008University of California, San Francisco
NCT00662077Phase 4Apr 17, 2008Badalona Hospital Germans Trias i Pujol, Fundacio Lluita Contra la SIDA
NCT00502736Phase 2Jan 1, 2008Roche
NCT00532220Phase 3Dec 1, 2007University of Bern
NCT00545207Phase 3Oct 16, 2007Roche
Showing 20 of 68 trials
Page 1 / 4

Organizations

Research & Development (57)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit373442002
GlaxoSmithKlineFor profit6222005
AlvogenFor profit2222011
Catholic University of KoreaAcademic/Hospital2122011
German Breast Group Forschungs GmbHFor profit2212004
National Cancer Institute (NCI)Government2012005
Seoul National UniversityAcademic/Hospital2122010
Southwest Oncology GroupAcademic/Hospital2212005
University of WashingtonAcademic/Hospital2012005
AmgenFor profit1112009
AstraZenecaFor profit1012004
Badalona Hospital Germans Trias i PujolAcademic/Hospital1112008
BA Research India LtdFor profit1012008
Canadian Cancer Trials GroupAcademic/Hospital1012005
Cancer and Leukemia Group B (CALGB)Academic/Hospital1012005
Cancer Research UKAcademic/Hospital1112003
Cardiff UniversityAcademic/Hospital1112006
Chinese Society of Lung CancerAcademic/Hospital1112007
Chinese University of Hong KongAcademic/Hospital1112007
ChugaiFor profit1112007
57 organizations
Page 1 / 3

Marketing (32)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 5, 2016
ApotexFor profitMKTGMar 19, 2012
ApotexFor profitSYNOct 16, 2015
Aurobindo PharmaFor profitMKTGAug 19, 2015
Aurobindo PharmaFor profitSYNMar 11, 2016
Avet LifesciencesFor profitMKTGSep 2, 2014
Chemi SpAFor profitMKTGSep 2, 2014
Cobalt Labs IncFor profitMKTGMar 15, 2011
Dr. Reddy's LaboratoriesFor profitMKTGApr 30, 2012
EmcureFor profitMKTGSep 2, 2014
Eugia PharmaFor profitMKTGAug 19, 2015
GlaxoSmithKlineFor profitMKTGMar 15, 2011
Macleods Pharmaceuticals, LtdFor profitMKTGOct 31, 2017
MylanFor profitSYNSep 2, 2014
MylanFor profitSYNMar 19, 2012
MylanFor profitMKTGMar 19, 2012
Nang Kuang Pharmaceutical Co., Ltd.For profitMKTGJun 16, 2021
NeogenFor profitMKTGOct 31, 2017
Orbion PharmsFor profitMKTGMar 19, 2012
Orchid PharmaFor profitMKTGMar 19, 2012
PHARMOBEDIENTFor profitMKTGMar 19, 2012
RocheFor profitSYNMay 16, 2003
RocheFor profitMKTGJan 6, 2006
RocheFor profitNDAMay 16, 2003
Sagent Pharmaceuticals, Inc.For profitMKTGSep 2, 2014
Sagent Pharmaceuticals, Inc.For profitSYNSep 2, 2014
Sun PharmaceuticalsFor profitSYNFeb 14, 2014
Sun PharmaceuticalsFor profitSYNAug 15, 2012
Sun PharmaceuticalsFor profitMKTGFeb 14, 2014
TevaFor profitSYNApr 3, 2009
TevaFor profitSYNMar 20, 2012
TevaFor profitMKTGApr 3, 2009