ibandronate
Trade name: boniva
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
Earliest trial started Apr 1, 2002 (NCT00048061)
Timeline
2000s
2010s
- Mar 15, 2011
Cobalt Labs Inc — Marketing Organization
- Mar 15, 2011
GlaxoSmithKline — Marketing Organization
- Mar 19, 2012
Apotex — Marketing Organization
- Mar 19, 2012
Orchid Pharma — Marketing Organization
- Mar 19, 2012
Orbion Pharms — Marketing Organization
- Mar 19, 2012
Mylan — Marketing Organization
- Mar 19, 2012
PHARMOBEDIENT — Marketing Organization
- Apr 30, 2012
Dr. Reddy's Laboratories — Marketing Organization
- Feb 14, 2014
Sun Pharmaceuticals — Marketing Organization
- Sep 2, 2014
Emcure — Marketing Organization
- Sep 2, 2014
Sagent Pharmaceuticals, Inc. — Marketing Organization
- Sep 2, 2014
Avet Lifesciences — Marketing Organization
- Sep 2, 2014
Chemi SpA — Marketing Organization
- Aug 19, 2015
Aurobindo Pharma — Marketing Organization
- Aug 19, 2015
Eugia Pharma — Marketing Organization
- Feb 5, 2016
Accord Research — Marketing Organization
- Oct 31, 2017
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Oct 31, 2017
Neogen — Marketing Organization
2020s
- Jun 16, 2021
Nang Kuang Pharmaceutical Co., Ltd. — Marketing Organization
Indications
Studied for
- Arthritis, Rheumatoid · Phase 4
- Bone Diseases, Metabolic · Phase 4
- Bone Marrow Diseases · Phase 3
- Bone Neoplasms · Phase 3
- Breast Neoplasms · Phase 3
- Fibrosis · Phase 4
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 3
- Hip Injuries · Phase 3
- HIV Infections · Phase 4
- Kidney Transplantation · Phase 2/Phase 3
- Knee Injuries · Phase 3
- Lung Neoplasms · Phase 4
- Lupus Erythematosus, Systemic · Phase 4
- Menopause · Phase 4
- Multiple Myeloma · Phase 3
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 3
- Osteoporosis · Phase 4
- Osteoporosis, Postmenopausal · Phase 4
- Pain · Phase 4
- Prostatic Neoplasms · Phase 3
Mechanism of action
- Farnesyl diphosphate synthaseINHIBITOR
FDPS inhibitor
Binds to the bone matrix (hydroxyapatite), and when the bone starts to be reabsorbed the compound is released and taken up by osteoclasts, inhibiting protein prenylation of the GTPases involved in the formation of the ruffled border
Approval history
- approvedMay 16, 2003
Chemistry & pharmacology
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
- ChEMBLCHEMBL3989569 ↗
- WikipediaIbandronic acid ↗
- NCATSUMD7G2653W ↗
- ChEMBLCHEMBL997 ↗
- ChEMBLCHEMBL1201008 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07242612 | N/A | Oct 1, 2025 | Khyber Medical University Peshawar |
| NCT06022237 | N/A | Sep 1, 2023 | Institute of Liver and Biliary Sciences, India |
| NCT04321837 | Phase 2 | Feb 5, 2020 | Columbia University, Osteoporosis Center of Armenia, University of California, Irvine |
| NCT05266261 | N/A | Oct 1, 2018 | Catholic University of Korea, Seoul National University, Sungkyunkwan University |
| NCT03186131 | Phase 2 | Jun 14, 2017 | Shinshu University |
| NCT02114489 | Phase 3 | Jun 1, 2014 | University of Lausanne |
| NCT02249741 | Phase 4 | Aug 1, 2012 | Sir Ganga Ram Hospital |
| NCT01581320 | Phase 3 | Dec 1, 2011 | Alvogen, Catholic University of Korea |
| NCT01429675 | Phase 1 | Aug 1, 2011 | Alvogen, University of Ulsan |
| NCT01290094 | Phase 3 | Apr 1, 2011 | Roche |
| NCT02616744 | Phase 2 | Jan 1, 2011 | University of Florence |
| NCT01287533 | Phase 4 | Apr 1, 2010 | Seoul National University |
| NCT00936897 | Phase 3 | Jul 1, 2009 | Amgen |
| NCT00824993 | Phase 3 | Dec 9, 2008 | Roche, University of Texas at Houston |
| NCT01627886 | Phase 1 | Sep 1, 2008 | BA Research India Ltd, Dr. Reddy's Laboratories |
| NCT00683163 | Phase 2/Phase 3 (Phase 3) | May 1, 2008 | University of California, San Francisco |
| NCT00662077 | Phase 4 | Apr 17, 2008 | Badalona Hospital Germans Trias i Pujol, Fundacio Lluita Contra la SIDA |
| NCT00502736 | Phase 2 | Jan 1, 2008 | Roche |
| NCT00532220 | Phase 3 | Dec 1, 2007 | University of Bern |
| NCT00545207 | Phase 3 | Oct 16, 2007 | Roche |
Organizations
Research & Development (57)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 37 | 34 | 4 | 2002 |
| GlaxoSmithKline | For profit | 6 | 2 | 2 | 2005 |
| Alvogen | For profit | 2 | 2 | 2 | 2011 |
| Catholic University of Korea | Academic/Hospital | 2 | 1 | 2 | 2011 |
| German Breast Group Forschungs GmbH | For profit | 2 | 2 | 1 | 2004 |
| National Cancer Institute (NCI) | Government | 2 | 0 | 1 | 2005 |
| Seoul National University | Academic/Hospital | 2 | 1 | 2 | 2010 |
| Southwest Oncology Group | Academic/Hospital | 2 | 2 | 1 | 2005 |
| University of Washington | Academic/Hospital | 2 | 0 | 1 | 2005 |
| Amgen | For profit | 1 | 1 | 1 | 2009 |
| AstraZeneca | For profit | 1 | 0 | 1 | 2004 |
| Badalona Hospital Germans Trias i Pujol | Academic/Hospital | 1 | 1 | 1 | 2008 |
| BA Research India Ltd | For profit | 1 | 0 | 1 | 2008 |
| Canadian Cancer Trials Group | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Cancer and Leukemia Group B (CALGB) | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Cancer Research UK | Academic/Hospital | 1 | 1 | 1 | 2003 |
| Cardiff University | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Chinese Society of Lung Cancer | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Chugai | For profit | 1 | 1 | 1 | 2007 |
Marketing (32)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Feb 5, 2016 |
| Apotex | For profit | MKTG | Mar 19, 2012 |
| Apotex | For profit | SYN | Oct 16, 2015 |
| Aurobindo Pharma | For profit | MKTG | Aug 19, 2015 |
| Aurobindo Pharma | For profit | SYN | Mar 11, 2016 |
| Avet Lifesciences | For profit | MKTG | Sep 2, 2014 |
| Chemi SpA | For profit | MKTG | Sep 2, 2014 |
| Cobalt Labs Inc | For profit | MKTG | Mar 15, 2011 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 30, 2012 |
| Emcure | For profit | MKTG | Sep 2, 2014 |
| Eugia Pharma | For profit | MKTG | Aug 19, 2015 |
| GlaxoSmithKline | For profit | MKTG | Mar 15, 2011 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Oct 31, 2017 |
| Mylan | For profit | SYN | Sep 2, 2014 |
| Mylan | For profit | SYN | Mar 19, 2012 |
| Mylan | For profit | MKTG | Mar 19, 2012 |
| Nang Kuang Pharmaceutical Co., Ltd. | For profit | MKTG | Jun 16, 2021 |
| Neogen | For profit | MKTG | Oct 31, 2017 |
| Orbion Pharms | For profit | MKTG | Mar 19, 2012 |
| Orchid Pharma | For profit | MKTG | Mar 19, 2012 |
| PHARMOBEDIENT | For profit | MKTG | Mar 19, 2012 |
| Roche | For profit | SYN | May 16, 2003 |
| Roche | For profit | MKTG | Jan 6, 2006 |
| Roche | For profit | NDA | May 16, 2003 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Sep 2, 2014 |
| Sagent Pharmaceuticals, Inc. | For profit | SYN | Sep 2, 2014 |
| Sun Pharmaceuticals | For profit | SYN | Feb 14, 2014 |
| Sun Pharmaceuticals | For profit | SYN | Aug 15, 2012 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 14, 2014 |
| Teva | For profit | SYN | Apr 3, 2009 |
| Teva | For profit | SYN | Mar 20, 2012 |
| Teva | For profit | MKTG | Apr 3, 2009 |