Drugs / Ibandronic acid

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Bondronat 1996-06-25 europa.eu

Trials 5 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT02616744 Jan 2011 → May 2016 breast cancer Careggi University Hospital Completed No outcome recorded
Phase 2 NCT00381368 Oct 2006 → ? breast cancer University of Turku Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT00447915 Mar 2007 → Aug 2011 osteoporosis Chugai Pharmaceutical Completed No outcome recorded
Phase 3 NCT00326820 Jan 2006 → Dec 2012 breast cancer, humoral hypercalcemia of malignancy, metastatic malignant neoplasm Wales Cancer Trials Unit Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT02249741 Aug 2012 → Feb 2014 cirrhosis of liver Dr. Ashish Kumar Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT00091832 Comparator Sep 2004 → Nov 2005 breast cancer, metastatic neoplasm Amgen Completed No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Ibandronic acid “Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial.” PMID 24332514 Dec 2013
5

“Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid” NCT00091832

NCT02616744

NCT02249741

NCT00381368

NCT00447915

Known as ibandronate “three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg” NCT00381368
Route Oral oral ibandronic acid 50 mg daily” PMID 24332514 Dec 2013