Drugs / Pamidronate
Pamidronate
also known as
Aredia · Acide pamidronique · Acido pamidronico · CGP 23339AE · disodium pamidronate · pamidronate disodium · Pamidronate Disodium DIN: 002244550 · Pamidronate disodium hydrate · +1 more
Small molecule targets FDPS via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | AREDIA | — | 1994-04-15 – 2002-07-12 | fda.gov ↗ |
| Approved | US (FDA) | AREDIA | — | 1991-10-31 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02544659 | Oct 2015 → Oct 2016 | SAPHO syndrome | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00548288 | Nov 2007 → ? | bone disorder | General and Teaching Hospital Celje | Unknown | No outcome recorded |
| Phase 1 | NCT00124605 | Apr 2005 → Jun 2009 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT00482378 | Mar 2005 → May 2007 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT01210599 | Apr 2004 → Oct 2009 | chronic pain syndrome | Pappagallo, Marco, M.D. | Completed | No outcome recorded |
| Phase 1/2 | NCT00022841 | ? → Sep 2005 | osteoporosis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | No outcome recorded |
| Phase 28 trials · 1 met primary | ||||||
| Phase 2 | NCT02594878 | Oct 2015 → May 2018 | immune system disorder, musculoskeletal system disorder | University of Aarhus | Unknown | No outcome recorded |
| Phase 2 | NCT02074631 | Feb 2015 → Oct 2022 | osteoporosis | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT01799616 | Jan 2013 → Jan 2015 | intervertebral disk degenerative disorder | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 2 | NCT01067989 | Mar 2010 → Apr 2014 | breast cancer | HaEmek Medical Center, Israel | Terminated | No outcome recorded |
| Phase 2 | NCT00104650 | Jan 2005 → Jan 2008 | bone neoplasm | Amgen | Completed | Met primary |
| Phase 2 | NCT00004088 | Apr 1999 → Jan 2018 | plasma cell myeloma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00083382 | Dec 1998 → May 2014 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT00083408 | Mar 1998 → May 2005 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00376883 | Jan 2000 → Oct 2006 | plasma cell myeloma | Nordic Myeloma Study Group | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT00108394 | Oct 2002 → Sep 2007 | osteoporosis, renal osteodystrophy | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00164008 | Oct 2002 → Dec 2005 | disease related to solid organ transplantation, osteoporosis | Bayside Health | Completed | No outcome recorded |
| Phase 4 | NCT00657852 | Dec 2000 → Dec 2003 | metabolic bone disorder | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT00128297 | Oct 2000 → Jun 2004 | breast cancer, metastatic malignant neoplasm | Spanish Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 4 | NCT00738257 | Jun 2000 → Dec 2004 | bone resorption disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT02007915 | Jul 2009 → May 2011 | avascular necrosis | The Hospital for Sick Children | Terminated | No outcome recorded |
| — | NCT00655681 | Sep 2007 → Aug 2011 | cerebral palsy, osteogenesis imperfecta, osteoporosis, spina bifida | University of New Mexico | Completed | No outcome recorded |
| — | NCT00262392 | Jun 2005 → Jun 2010 | — | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |
| — | NCT00302627 | Jan 1999 → Nov 2002 | disease related to transplantation | Providence Health & Services | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT00101790 Comparator | Sep 2003 → Jun 2010 | — | Icahn School of Medicine at Mount Sinai | Unknown | No outcome recorded |
| Phase 2 | NCT01215344 Background | Nov 2010 → Nov 2015 | plasma cell myeloma | Vanderbilt-Ingram Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00091832 Comparator | Sep 2004 → Nov 2005 | breast cancer, metastatic neoplasm | Amgen | Completed | Missed primary |
| Phase 2 | NCT00004906 Background | Oct 1999 → Jun 2001 | breast cancer | Hackensack Meridian Health | Completed | No outcome recorded |
| Phase 3 | NCT00033332 Background | Apr 2002 → Mar 2006 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 3 | NCT00005901 Comparator | Jun 2000 → May 2014 | osteogenesis imperfecta | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 4 | NCT04549207 Comparator | Oct 2020 → Apr 2025 overdue | breast cancer, castration-resistant prostate carcinoma | Ottawa Hospital Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02721433 Comparator | Aug 2016 → Sep 2019 | breast cancer, metastatic neoplasm, prostate cancer | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02313727 Comparator | Dec 2014 → Jun 2017 | ankylosing spondylitis | Bnai Zion Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02101164 Comparator | Nov 2014 | disease of bone structure, neoplasm | Amgen | Withdrawn | No outcome recorded |
| Phase 4 | NCT01907880 Comparator | Aug 2012 → Jan 2016 | breast cancer | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01718951 Comparator | Aug 2012 → Mar 2014 | spondyloarthropathy | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00159419 Comparator | Aug 1999 → Aug 2008 | bone Paget disease, osteogenesis imperfecta, osteoporosis | Indiana University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2009-01-07 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma receives USFDA approvals for 4 generic products; company receives its first controlled substance product approval sunpharma.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-01-07 | Sun Pharmaceutical Industries, Inc. | Sun Pharma receives USFDA approvals for 4 generic products; company receives its first controlled substance product approval sunpharma.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pamidronate | “Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid” NCT00091832 ↗35“IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase.” NCT00104650 ↗ “the bisphosphonate pamidronate has been described relief pain in small cohorts in retrospective studies.” NCT02594878 ↗ “Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.” NCT01215344 ↗ “Pamidronate” NCT04549207 ↗ |
| Known as | Acide pamidronique | ChEMBL registry synonym — accepted as the source's own label CHEMBL834 ↗ |
| Known as | Acido pamidronico | ChEMBL registry synonym — accepted as the source's own label CHEMBL834 ↗ |
| Known as | Aredia | “Pamidronate (AREDIA) vs radiation” NCT00262392 ↗1“Pamidronate (Aredia)” NCT00005901 ↗ |
| Known as | CGP 23339AE | ChEMBL registry synonym — accepted as the source's own label CHEMBL834 ↗ |
| Known as | disodium pamidronate | “Patients of the treatment group will receive a single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5%...” NCT00657852 ↗ |
| Known as | pamidronate disodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00033332 ↗ |
| Known as | Pamidronate Disodium DIN: 002244550 | “Pamidronate Disodium DIN: 002244550” NCT02007915 ↗ |
| Known as | Pamidronate disodium hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL834 ↗ |
| Known as | Pamidronate disodium pentahydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL834 ↗ |
| Action | Inhibit | “Pamidronate, an aminobisphosphonate, is a potent inhibitor of bone resorption.” NCT00005901 ↗1“Farnesyl diphosphate synthase inhibitor” CHEMBL834 ↗ |
| Modality | Small molecule | “Pamidronate, an aminobisphosphonate” NCT00005901 ↗ |
| Route | Intravenous | “pamidronate IV every 4 weeks until disease progression” NCT00004088 ↗ |
| Target | FDPS | “Farnesyl diphosphate synthase inhibitor” CHEMBL834 ↗ |