Drugs / Minodronic acid
Minodronic acid
also known as
ONO-5920 · Minodronate · YM529 · Acide minodronique · Acido minodronico · Minodronate Tablets · NSC-725590
Small molecule targets FDPS via inhibition
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02295436 | Aug → Oct 2014 | osteoporosis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Completed | No outcome recorded |
| Phase 1 | NCT00965978 | Jul → Sep 2009 | disease of bone structure, postmenopausal osteoporosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00794443 | Nov 2008 → Apr 2010 | osteoporosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT05305183 | May 2022 → May 2023 | osteoporosis | Shandong New Time Pharmaceutical Co., LTD | Unknown | No outcome recorded |
| Phase 3 | NCT00212628 | Jun 2004 → ? | osteoporosis | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00212719 | May 2003 → Apr 2006 | osteoporosis | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00212667 | Aug 2002 → Sep 2006 | osteoporosis | Ono Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05645289 | Jan → Dec 2023 | postmenopausal osteoporosis | Peking University Third Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2011-07-01 | Astellas Pharma Inc | Regulatory Approval for RECALBON® Tablets 50mg/ Bonoteo® Tablets 50mg, Once per 4 weeks Oral Osteoporosis Treatment in Japan astellas.com ↗ |
| 2010-09-10 | Astellas Pharma Inc | Regulatory Application for RECALBON® Tablets 50mg/ Bonoteo® Tablets 50mg, A Monthly Oral Osteoporosis Treatment in Japan astellas.com ↗
announced the submission of a market authorization application for RECALBON® Tablets 50mg (Ono) / Bonoteo® Tablets 50mg (Astellas) (generic name: minodronic acid hydrate) to Pharmaceuticals and Medical Devices Agency today in Japan. |
| 2009-01-21 | Astellas Pharma Inc | Regulatory Approval for the Osteoprosis Treatment, RECALBON® Tablets / Bonoteo® Tablets astellas.com ↗
RECALBON® Tablets 1 mg (Ono) / Bonoteo® Tablets 1 mg (Astellas) (generic name: minodronic acid hydrate) was granted a Japanese marketing approval on January 21, 2009. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-07-01 | Astellas Pharma Inc | Approval for RECALBON® Tablets 50mg/ Bonoteo® Tablets 50mg, Once per 4 weeks Oral Osteoporosis Treatment in Japan astellas.com ↗ |
| 2010-09-10 | Astellas Pharma Inc | Application for RECALBON® Tablets 50mg/ Bonoteo® Tablets 50mg, A Monthly Oral Osteoporosis Treatment in Japan astellas.com ↗ |
| 2009-01-21 | Astellas Pharma Inc | Approval for the Osteoprosis Treatment, RECALBON® Tablets / Bonoteo® Tablets astellas.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | minodronic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02295436 ↗ |
| Known as | Acide minodronique | ChEMBL registry synonym — accepted as the source's own label CHEMBL319144 ↗ |
| Known as | Acido minodronico | ChEMBL registry synonym — accepted as the source's own label CHEMBL319144 ↗ |
| Known as | Minodronate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05645289 ↗ |
| Known as | Minodronate Tablets | “subjects received 50mg minodronate tablets monthly and an alendronate sodium tablets -matching placebo weekly for 48 weeks.” NCT05305183 ↗ |
| Known as | NSC-725590 | ChEMBL registry synonym — accepted as the source's own label CHEMBL319144 ↗ |
| Known as | ONO-5920 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00212719 ↗ |
| Known as | YM529 | “ONO-5920 / YM529” NCT00965978 ↗ |
| Action | Inhibit | “Farnesyl diphosphate synthase inhibitor” CHEMBL319144 ↗ |
| Modality | Small molecule | “Minodronate is an oral bisphosphonate” PMID 39135126 ↗ Aug 2024 |
| Route | Oral | “young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days.” NCT02295436 ↗ |
| Target | FDPS | “Farnesyl diphosphate synthase inhibitor” CHEMBL319144 ↗ |