Drugs / Ibandronic acid
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed osteoporosis 1 milestone | |||||
| Filed | Japan (PMDA) | Bonviva Tablet | osteoporosis | 2015-02-10 | “On February 10, 2015, Chugai filed a new drug application to the MHLW with the results of the pivotal Japanese studies.” chugai-pharm.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Bondronat | — | 1996-06-25 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT02616744 | Jan 2011 → May 2016 | breast cancer | Careggi University Hospital | Completed | Met primary |
| Phase 2 | NCT00381368 | Oct 2006 → ? | breast cancer | University of Turku | Unknown | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| 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 | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT02249741 | Aug 2012 → Feb 2014 | cirrhosis of liver | Dr. Ashish Kumar | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00091832 Comparator | Sep 2004 → Nov 2005 | breast cancer, metastatic neoplasm | Amgen | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2016-01-22 | Chugai Pharmaceutical | Regulatory Agent for Osteoporosis Approved in Japan “Bonviva ® Tablet” chugai-pharm.co.jp ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2016-01-22 | Chugai Pharmaceutical | Agent for Osteoporosis Approved in Japan “Bonviva ® Tablet” chugai-pharm.co.jp ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited 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 20135“Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid” NCT00091832 ↗ |
| 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 |