Ibandronate

Overview

Ibandronate, or BM 21.0955, is a third generation, nitrogen containing bisphosphonate similar to zoledronic acid, minodronic acid, and risedronic acid. It is used to prevent and treat postmenopausal osteoporosis. Ibandronate was first described in the literature in 1993 as a treatment for bone loss in dogs. Ibandronate was granted FDA approval on 16 May 2003.

Indication

For the treatment and prevention of osteoporosis in postmenopausal women.

Associated Conditions

Bone Metastases
Hypercalcemia of Malignancy
Osteoporosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.	2023/09/01	NCT06022237	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Use of Ibandronate in Diabetic Patients	2022/03/04	NCT05266261	Not Applicable	Completed	Yeouido St. Mary's Hospital
Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate	2020/03/25	NCT04321837	Phase 2	Completed	Columbia University
Efficacy of Oral Ibandronate in Osteoporosis	2017/06/14	NCT03186131	Phase 2	Recruiting	Shinshu University
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo	2016/10/31	NCT02948881	Phase 4	Completed	GlaxoSmithKline
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma	2016/04/15	NCT02739594	Phase 3	Terminated	Hoffmann-La Roche
A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer	2016/03/23	NCT02716792	Phase 3	Completed	Hoffmann-La Roche
Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors	2015/11/30	NCT02616744	Phase 2	Completed	Azienda Ospedaliero-Universitaria Careggi
A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia	2015/11/13	NCT02604836	Phase 4	Completed	Hoffmann-La Roche
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis	2015/11/06	NCT02598934	Phase 4	Completed	Hoffmann-La Roche

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
IBANDRONATE SODIUM	Bionpharma Inc.	69452-378	ORAL	150 mg in 1 1	5/23/2023
Ibandronate Sodium	Aurobindo Pharma Limited	65862-237	ORAL	150 mg in 1 1	1/31/2024
IBANDRONATE SODIUM	Golden State Medical Supply, Inc.	60429-643	ORAL	150 mg in 1 1	9/25/2023
Ibandronate Sodium	AuroMedics Pharma LLC	55150-191	INTRAVENOUS	3 mg in 3 mL	5/5/2022
IBANDRONATE SODIUM	Macleods Pharmaceuticals Limited	33342-150	ORAL	150 mg in 1 1	7/2/2022
Ibandronate Sodium	Accord Healthcare Inc.	16729-274	INTRAVENOUS	3 mg in 3 mL	1/9/2024
IBANDRONATE SODIUM	Apotex Corp	60505-2795	ORAL	150 mg in 1 1	9/14/2023
Ibandronate sodium	Dr. Reddy's Laboratories Limited	55111-575	ORAL	150 mg in 1 1	4/30/2023
IBANDRONATE SODIUM	Alvogen Inc.	47781-103	ORAL	150 mg in 1 1	1/1/2017
Ibandronate Sodium	Apotex Corp.	60505-6097	INTRAVENOUS	3 mg in 3 mL	12/14/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Ibandronic Acid Sandoz	Sandoz GmbH,Biochemiestrasse 10,6250 Kundl,Austria	Authorised	7/26/2011
Bonviva	Atnahs Pharma Netherlands B.V.,Copenhagen Towers,,Ørestads Boulevard 108, 5.tv,DK-2300 København S,Denmark	Authorised	2/23/2004
Bondronat	Atnahs Pharma Netherlands B.V.,Copenhagen Towers,,Ørestads Boulevard 108, 5.tv,DK-2300 København S,Denmark	Authorised	6/25/1996
Ibandronic Acid Teva	Teva Pharma B.V.,Computerweg 10,NL-3542 DR Utrecht,The Netherlands	Authorised	9/17/2010
Ibandronic acid Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	11/18/2012
Iasibon	Pharmathen S.A.,6, Dervenakion,EL-15351 Pallini Attiki,Greece	Authorised	1/21/2011

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Bondronat Tablet 50mg	F.Hoffmann-La Roche Ltd, Penn Pharmaceutical Services Ltd	SIN13425P	TABLET, FILM COATED	50mg	3/10/2008
BONDRONAT FOR INFUSION 1 mg/ml	ROCHE DIAGNOSTICS GMBH	SIN11206P	INJECTION	1mg/ml	10/29/1999
Bonviva Pre-Filled Syringe 3mg/3ml	Vetter Pharma-Fertigung GmbH & Co. KG	SIN13328P	INJECTION, SOLUTION	3mg/3ml	8/2/2007
Bonviva Tablet 150 mg	PENN PHARMACEUTICAL SERVICES LTD, Waymade PLC (Primary and Secondary Packager)	SIN13206P	TABLET, FILM COATED	168.75 mg	6/19/2006

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BONDRONAT ibandronic acid 6mg/6mL (as sodium) injection vial	98008	Atnahs Pharma Australia Pty Ltd	Medicine	A	4/13/2004
BONDRONAT ibandronic acid 50mg film-coated tablet blister pack	119673	Atnahs Pharma Australia Pty Ltd	Medicine	A	8/24/2006

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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