Drugs / Ibandronate
Ibandronate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BONIVA | — | 2005-03-24 – 2008-11-28 | fda.gov ↗ |
| Approved | US (FDA) | BONIVA | — | 2003-05-16 | fda.gov ↗ |
Trials 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01577849 | Mar → Jun 2012 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT01429675 | Aug 2011 → Feb 2012 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00502736 | Jan 2008 → Mar 2009 | metastatic carcinoma in the bone | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00478270 | Jun 2007 → Feb 2008 | bone neoplasm, metastatic neoplasm | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00423384 | Jan 2007 → Dec 2009 | — | Smerud Medical Research International AS | Unknown | No outcome recorded |
| Phase 319 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT02114489 | Jun 2014 → Mar 2017 | avascular necrosis | Brigitte Jolles, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01581320 | Dec 2011 → Sep 2012 | postmenopausal osteoporosis | Alvogen Korea | Completed | No outcome recorded |
| Phase 3 | NCT01290094 | Apr 2011 → Jul 2014 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00824993 | Dec 2008 → Apr 2017 | hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00493623 | Jun 2007 → Dec 2009 | osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00397839 | Jan 2007 → Oct 2008 | osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00545779 | Dec 2006 → Oct 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02561039 | Dec 2006 → Mar 2008 | metastatic carcinoma in the bone | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00301886 | May 2006 | breast cancer, humoral hypercalcemia of malignancy, metastatic malignant neoplasm | SWOG Cancer Research Network | Withdrawn | No outcome recorded |
| Phase 3 | NCT02739594 | Feb 2006 → Apr 2009 | plasma cell myeloma | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02716792 | Jan 2006 → Jun 2008 | metastatic carcinoma in the bone | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00099177 | Aug 2005 → Dec 2007 | bone neoplasm, metastatic malignant neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT00099203 | Jul 2005 → Dec 2007 | bone neoplasm, metastatic neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT00127205 | Jul 2005 → Dec 2017 | breast cancer | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT00092053 | Dec 2004 → Jul 2005 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00082927 | Apr 2003 → Jul 2011 | metastatic malignant neoplasm, prostate cancer | Cancer Research UK | Completed | No outcome recorded |
| Phase 3 | NCT00048074 | Jun 2002 → May 2005 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00048061 | Apr 2002 → Dec 2004 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00545207 | ? → Sep 2010 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 422 trials · 6 met primary | ||||||
| Phase 4 | NCT07406685 | Mar 2026 → Mar 2030 expected | postmenopausal osteoporosis | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01287533 | Apr 2010 → Apr 2014 | osteoporosis, rheumatoid arthritis | Yeong-Wook Song | Completed | Met primary |
| Phase 4 | NCT00492843 | Jul 2007 → Jan 2008 | lung cancer | Chinese Society of Lung Cancer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00503113 | Jul 2007 → Apr 2010 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00405392 | Mar 2007 → May 2008 | postmenopausal osteoporosis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00545090 | Aug 2006 → Jun 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02553707 | Jul 2006 → Dec 2008 | metastatic carcinoma in the bone | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00446589 | Jul 2006 → ? | osteoporosis | Papageorgiou General Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00545051 | May 2006 → May 2009 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT00377234 | May 2006 → Aug 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT00545363 | Apr 2006 → Jan 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00303485 | Feb 2006 → Jun 2007 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT00129623 | Dec 2005 → Dec 2007 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | Met primary |
| Phase 4 | NCT00148915 | Aug 2005 → Aug 2007 | osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02948881 | Aug 2005 → Jul 2007 | osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00327990 | Apr 2005 → Dec 2006 | osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02598453 | Jan 2005 → Sep 2006 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02564107 | Nov 2004 → Apr 2006 | metastatic carcinoma in the bone | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02598934 | Aug 2004 → May 2006 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02604836 | Jun 2004 → Apr 2006 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT02598440 | Mar 2004 → May 2005 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00662077 | — | HIV infectious disease | Germans Trias i Pujol Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase not applicable2 trials | ||||||
| — | NCT06022237 | Sep 2023 → Aug 2024 | cirrhosis of liver, disease of bone structure | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT05266261 | Oct 2018 → Aug 2021 | postmenopausal osteoporosis, type 2 diabetes mellitus | Yeouido St. Mary's Hospital | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00493532 | Jun 2007 → Dec 2010 | postmenopausal osteoporosis | Hoffmann-La Roche | No longer available | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 2 | NCT07043608 Background | May 2026 → Feb 2029 expected | clear cell renal carcinoma, metastatic carcinoma in the bone | Kelly Fitzgerald, MD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04321837 Comparator | Feb 2020 → Mar 2023 | postmenopausal osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT03186131 Comparator | Oct 2017 → Dec 2022 | osteoporosis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT00666627 Comparator | Apr 2007 → Sep 2012 | postmenopausal osteoporosis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2/3 | NCT00683163 Comparator | May 2008 → Apr 2011 | osteoporosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00936897 Comparator | Jul 2009 → Nov 2011 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT00532220 Comparator | Dec 2007 → Aug 2015 | bone marrow disorder, osteonecrosis | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 3 | NCT00196859 Comparator | Jun 2004 → Jan 2014 | breast cancer | GBG Forschungs GmbH | Completed | Missed primary |
| Phase 4 | NCT00668330 Comparator | Apr 2007 → May 2009 | systemic lupus erythematosus | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT00545480 Comparator | Jul 2006 → Mar 2009 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00271713 Comparator | Mar 2006 → Sep 2007 | postmenopausal osteoporosis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT00545909 Comparator | Mar 2006 → Aug 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00551174 Comparator | Oct 2004 → Nov 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00081653 Comparator | May 2004 → Nov 2007 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| — | NCT07242612 Comparator | Oct 2025 → Mar 2026 overdue | postmenopausal osteoporosis | Khyber Medical University Peshawar | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-01-22 | Chugai Pharmaceutical | Regulatory Agent for Osteoporosis Approved in Japan “Bonviva ® Tablet” chugai-pharm.co.jp ↗ |
| 2010-12-30 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA tentative approval for generic Boniva® sunpharma.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-24 | Chugai Pharmaceutical | Transfer and Future Marketing of Osteoporosis Agent Bonviva in Japan chugai-pharm.co.jp ↗ |
| 2016-04-21 | Chugai Pharmaceutical | Launch of the Agent for Osteoporosis “Bonviva ® Tablet 100 mg” chugai-pharm.co.jp ↗ |
| 2016-01-22 | Chugai Pharmaceutical | Agent for Osteoporosis Approved in Japan “Bonviva ® Tablet” chugai-pharm.co.jp ↗ |
| 2010-12-30 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA tentative approval for generic Boniva® sunpharma.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ibandronate | “a newly developed ibandronate 150-mg/vitamin D3 24,000-IU tablet (DP-R206, test drug)” PMID 24378207 ↗ Dec 201363“<Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>” NCT01581320 ↗ “150mg Ibandronate once a month” NCT01429675 ↗ “Ibandronate” NCT07043608 ↗ |
| Known as | Bondronat | “This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and...” NCT02561039 ↗5“ibandronate [Bondronat]” NCT00099203 ↗ “ibandronate [Bondronat]” NCT00099177 ↗ “ibandronate [Bondronat]” NCT00478270 ↗ “ibandronate [Bondronat]” NCT00502736 ↗ “Ibandronate (Bondronat)” NCT00492843 ↗ |
| Known as | Boniva | “The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.” NCT02948881 ↗15“treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis” NCT01290094 ↗ “Drug: Ibandronate [Bonviva/Boniva]” NCT00048061 ↗ “Drug: ibandronate [Bonviva/Boniva]” NCT00545207 ↗ “ibandronate [Bonviva/Boniva]” NCT00503113 ↗ “ibandronate [Bonviva/Boniva]” NCT00303485 ↗ “ibandronate [Bonviva/Boniva]” NCT00377234 ↗ “ibandronate [Bonviva/Boniva]” NCT00048074 ↗ “ibandronate [Bonviva/Boniva]” NCT00545909 ↗ “ibandronate [Bonviva/Boniva]” NCT00545480 ↗ “ibandronate [Bonviva/Boniva]” NCT00551174 ↗ |
| Known as | Bonviva | “Ibandronate IV (Bonviva® IV), 10.5 mg divided in 4 single infusions within 2 weeks(1x1.5 mg, 3x3 mg), followed by a fifth infusion after 3 months (V4)” NCT00532220 ↗15“treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis” NCT01290094 ↗ “MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis” NCT00048061 ↗ “Drug: ibandronate [Bonviva/Boniva]” NCT00545207 ↗ “ibandronate [Bonviva/Boniva]” NCT00048074 ↗ “ibandronate [Bonviva/Boniva]” NCT00377234 ↗ “ibandronate [Bonviva/Boniva]” NCT00545909 ↗ “ibandronate [Bonviva/Boniva]” NCT00303485 ↗ “ibandronate [Bonviva/Boniva]” NCT00545480 ↗ “ibandronate [Bonviva/Boniva]” NCT00081653 ↗ “ibandronate [Bonviva/Boniva]” NCT00503113 ↗ |
| Known as | ibandronate sodium | “The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone...” NCT00148915 ↗2“The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.” NCT02948881 ↗ “Drug: ibandronate sodium” NCT00127205 ↗ |
| Known as | IBN | “low-dose alendronate/calcitriol combination [MXM, n=118], alendronate [ALD, n=53], risedronate [RIS, n=20], ibandronate [IBN, n=30], zoledronic acid [ZOL, n=106], selective...” PMID 39933434 ↗ Feb 2025 |
| Known as | SB743830HD | “Ibandronate (SB743830HD)” NCT00405392 ↗ |
| Action | Inhibit | “by decreasing bone resorption” NCT06022237 ↗ |
| Modality | Other / unclassified | “Bisphosphonates reduce bone metastases in postmenopausal women with early-stage breast cancer” PMID 32929540 ↗ Sep 2020 |
| Route | Oral | “Per oral (PO) daily” NCT00048061 ↗ |