Drugs / Risedronate
Risedronate
also known as
Actonel · Risedronate sodium · HMR4003 · Acide risedronique · Acido risedronico · ActonelR · Atelvia · bisphosphonate · +10 more
Small molecule targets FDPS via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | ACTONEL | — | 2000-04-14 – 2009-07-23 | fda.gov ↗ |
| Approved | US (FDA) | ACTONEL | — | 1998-03-27 | fda.gov ↗ |
Trials 56 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00717145 | Jul → Sep 2008 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 1 | NCT00755872 | Nov 2007 → Feb 2008 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 1 | NCT00577850 | Nov 2002 → Feb 2004 | osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00266708 | Oct 2002 → Jul 2008 | renal osteodystrophy | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07471815 | Mar 2026 → Mar 2028 expected | triple-negative breast carcinoma | Harbin Medical University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03861091 | Jul 2019 → Mar 2022 | lung neoplasm | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03208582 | Apr → Nov 2017 | osteogenesis imperfecta | Sheffield Children's NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT00577720 | Jul 2006 → Jan 2007 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 2 | NCT01038011 | Jun 2004 → Aug 2006 | ankylosing spondylitis | University of Zurich | Completed | No outcome recorded |
| Phase 2 | NCT00577837 | Apr 2004 → Jun 2005 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 2 | NCT00351091 | Nov 2002 → Jun 2003 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00445575 | Jul 2007 → Dec 2017 | fibrous dysplasia | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT04922333 | Mar 2023 → Apr 2028 expected | disease of bone structure | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT02744482 | May 2016 → Mar 2018 | — | University Hospital, Limoges | Terminated | No outcome recorded |
| Phase 3 | NCT02186600 | Feb 2015 → Jun 2019 | — | University of Nebraska | Completed | No outcome recorded |
| Phase 3 | NCT01575873 | Mar 2012 → Jun 2016 | corticosteroid-induced osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00541658 | Oct 2007 → Apr 2010 | postmenopausal osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00386360 | Apr 2006 → Sep 2009 | osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00345644 | Mar 2006 → Jun 2009 | osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00247273 | Oct 2005 → Mar 2008 | postmenopausal osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00138866 | Nov 2004 → Jan 2009 | osteoporosis | Toronto Rehabilitation Institute | Completed | No outcome recorded |
| Phase 3 | NCT00106028 | Nov 2004 → Apr 2008 | osteogenesis imperfecta | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00358176 | Jul 2004 → Mar 2007 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00216060 | Oct 2003 → Feb 2008 | metastatic prostate carcinoma | Christopher Sweeney, MBBS | Terminated | No outcome recorded |
| Phase 3 | NCT00577421 | Jun 2003 → Jan 2006 | postmenopausal osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00092040 | Mar 2003 → Oct 2004 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00054418 | Mar 2003 → Apr 2007 | breast cancer, osteoporosis | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT00324714 | Feb 2003 → ? | breast cancer, osteoporosis | ETOP IBCSG Partners Foundation | Withdrawn | No outcome recorded |
| Phase 3 | NCT00353080 | Dec 2002 → Apr 2005 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00043069 | Nov 2002 → Jun 2006 | osteoporosis, prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT00619957 | Jun 2002 → May 2007 | osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00136058 | Jan 2002 → Apr 2006 | osteoporosis | University of Alberta | Completed | No outcome recorded |
| Phase 3 | NCT00150696 | Feb 2000 → Nov 2005 | spinal cord injury | Toronto Rehabilitation Institute | Completed | No outcome recorded |
| Phase 3 | NCT00268632 | Aug 1999 → Feb 2002 | osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 419 trials | ||||||
| Phase 4 | NCT05630768 | Jan 2023 → Jul 2025 | postmenopausal osteoporosis | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04152551 | Nov 2019 → Jan 2027 expected | osteogenesis imperfecta | Hospital for Special Surgery, New York | Recruiting | No outcome recorded |
| Phase 4 | NCT01904110 | Dec 2012 → May 2014 | osteoporosis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00577395 | Jul 2008 → Feb 2009 | osteoporosis | Warner Chilcott | Terminated | No outcome recorded |
| Phase 4 | NCT00594334 | Jan 2008 → Jan 2010 | periodontal disorder | University Hospitals Cleveland Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00485953 | Sep 2007 → Mar 2013 | breast cancer, osteoporosis | Susan L. Greenspan | Completed | No outcome recorded |
| Phase 4 | NCT00460733 | Mar 2007 → Sep 2011 | — | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00544180 | May 2005 → Sep 2006 | osteoporosis | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00790101 | Jun → Oct 2004 | postmenopausal osteoporosis | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00632216 | May 2004 → May 2006 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00082277 | Apr 2004 → Oct 2007 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00372372 | Jan 2004 → Apr 2007 | osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00453492 | Jan 2004 → ? | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00549965 | Oct 2003 → ? | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00549068 | Feb 2003 → Nov 2004 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00859027 | Jan 2003 → Mar 2008 | prostate cancer | UConn Health | Completed | No outcome recorded |
| Phase 4 | NCT00402441 | Sep 2002 → Jun 2004 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00616694 | Jul 2002 → Dec 2004 | osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01882400 | May 2001 → Sep 2007 | cystic fibrosis, muscular dystrophy, osteoporosis | Gilles Boire | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05346419 | Jul 2021 → Feb 2022 | hyperparathyroidism, postmenopausal osteoporosis, vitamin D deficiency | Hospital Regional 1o de Octubre | Completed | No outcome recorded |
| — | NCT00145704 | Jun 2002 → Oct 2008 | — | State University of New York - Upstate Medical University | Terminated | No outcome recorded |
| — | NCT00567606 | Apr 2002 → Dec 2007 | postmenopausal osteoporosis | University of Nebraska | Completed | No outcome recorded |
Also used as a comparator or background therapy in 36 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00868907 Comparator | Mar → Apr 2009 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00918749 Comparator | May → Oct 2009 | postmenopausal osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 2 | NCT00666627 Comparator | Apr 2007 → Sep 2012 | postmenopausal osteoporosis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02063854 Comparator | Feb 2014 → Nov 2015 | osteoporosis | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT00089843 Comparator | Jun 2003 → Apr 2008 | anorexia nervosa | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT00859703 Comparator | Nov 2009 → Oct 2013 | breast cancer, osteoporosis | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 3 | NCT01806792 Comparator | Nov 2009 → Aug 2010 | postmenopausal osteoporosis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00919711 Comparator | Sep 2009 → Dec 2011 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00687661 Comparator | Oct 2008 → Jun 2013 | chronic kidney disease | Queen's University | Completed | No outcome recorded |
| Phase 3 | NCT00503399 Comparator | Jul 2007 → Oct 2010 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00426777 Comparator | Jan 2007 → Jan 2009 | prostate cancer | CMX Research | Completed | No outcome recorded |
| Phase 3 | NCT00365456 Comparator | Jul 2006 → Jan 2011 | osteoporosis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00343252 Comparator | Jun 2006 → Jun 2009 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00354302 Background | Apr 2006 → Mar 2011 | female breast carcinoma, osteoporosis | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00452439 Comparator | Feb 2004 → Aug 2014 | leukemia, lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT01611571 Comparator | Dec 2003 → Nov 2011 | osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 3 | NCT00092014 Comparator | Sep 2002 → Apr 2004 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00103740 Comparator | Apr 2002 → Dec 2003 | bone Paget disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01249261 Comparator | Oct 2001 → May 2003 | postmenopausal osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00051636 Comparator | Jan 2001 → Mar 2004 | bone Paget disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT03411902 Comparator | Jun 2018 → Jul 2020 | disease of bone structure | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT03811509 Comparator | Jan 2016 → Jan 2021 | arthropathy, osteoporosis | Parc de Salut Mar | Unknown | No outcome recorded |
| Phase 4 | NCT02148848 Comparator | Jun 2013 → Oct 2017 | postmenopausal osteoporosis | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT01709110 Comparator | Oct 2012 → Jul 2016 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT01675297 Comparator | Jul 2011 → Dec 2013 | osteoporosis | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00887354 Comparator | Apr 2009 → Aug 2015 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00869622 Comparator | Jun 2006 → Oct 2012 | disease of bone structure, epilepsy, osteoporosis | Boston VA Research Institute, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00377234 Comparator | May 2006 → Aug 2008 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00772395 Comparator | Apr 2006 → Feb 2013 | bone resorption disease | Danderyd Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00221299 Comparator | Sep 2005 → Mar 2009 | osteoporosis | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT00130403 Background | Mar 2004 → Mar 2007 | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01215890 Comparator | — | Crohn disease, osteoporosis | University of Alberta | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07242612 Comparator | Oct 2025 → Mar 2026 overdue | postmenopausal osteoporosis | Khyber Medical University Peshawar | Recruiting | No outcome recorded |
| — | NCT01406444 Comparator | Oct 2011 → May 2019 | anorexia nervosa, osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT01950169 Comparator | Dec 2004 → May 2009 | bone disorder | Karolinska Institutet | Completed | No outcome recorded |
| — | NCT00118508 Comparator | May 2003 → Jul 2006 | osteoporosis | University of Pittsburgh | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-06-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Exclusive Launch of Generic Actonel® Tablets in the United States tevapharm.com ↗ |
| 2014-12-08 | Amgen | FDA Approves Amgen's XGEVA® (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy amgen.com ↗ |
| 2009-05-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update On Generic Actonel® Litigation tevapharm.com ↗ |
| 2008-02-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update On Generic Actonel® Litigation tevapharm.com ↗ |
| 2007-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Generic Actonel® tevapharm.com ↗ |
| 2005-08-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Risedronate Sodium Tablets tevapharm.com ↗ |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 95 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Risedronate | “G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.” NCT00567606 ↗83“Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D.” PMID 30816640 ↗ May 2019 “Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study” NCT01038011 ↗ “150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.” NCT00918749 ↗ |
| Known as | Acide risedronique | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | Acido risedronico | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | Actonel | “A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus...” NCT01215890 ↗11“Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in...” NCT00632216 ↗ “Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study” NCT01038011 ↗ “Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.” NCT00594334 ↗ “Risedronate Sodium 35 MG [Actonel]” NCT05630768 ↗ “risedronate sodium (Actonel®)” NCT00460733 ↗ “risedronate sodium (Actonel)” NCT00106028 ↗ “Risedronate Sodium (Actonel)” NCT00549068 ↗ “Actonel (Risedronate)” NCT00452439 ↗ “Risedronate (Actonel)” NCT00054418 ↗ |
| Known as | ActonelR | “risedronate 35mg (ActonelR 35mg weekly tablet) versus placebo” NCT01038011 ↗ |
| Known as | Atelvia | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | bisphosphonate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03811509 ↗ |
| Known as | HMR4003 | “risedronate (HMR4003)” NCT00353080 ↗ |
| Known as | NE-58095 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02063854 ↗ |
| Known as | NE-58095 ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | NSC-722598 | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | NSC-759280 | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | Optinate Septimum | “The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months.” NCT01950169 ↗ |
| Known as | Other name : Actonel(Risedronate 150mg) | “Other name : Actonel(Risedronate 150mg)” NCT01806792 ↗ |
| Known as | Residronate | “Residronate” NCT00687661 ↗ |
| Known as | Risedronate monosodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | Risedronate sodium | “Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in...” NCT00632216 ↗9“Risedronate sodium, a pyridinyl bisphospho- nate, is an antiresorptive drug approved by the US Food and Drug Administration for the prevention and treatment of osteoporosis in...” PMID 18035193 ↗ Sep 2007 “Intervention : Risedronate Sodium (oral) Dosage: 1mg/kg/week Frequency: once/week Duration: 6 weeks” NCT03208582 ↗ “Risedronate Sodium 35 MG [Actonel]” NCT05630768 ↗ “risedronate sodium (Actonel®)” NCT00460733 ↗ “Risedronate Sodium (Actonel)” NCT00549068 ↗ “risedronate sodium (Actonel)” NCT00106028 ↗ |
| Known as | Risedronate sodium anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Known as | Risedronic acid monosodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL923 ↗ |
| Action | Inhibit | “Their major action is to prevent bone breakdown by stopping the normal process of removing and then replacing old bone tissue” NCT03208582 ↗1“Farnesyl diphosphate synthase inhibitor” CHEMBL923 ↗ |
| Modality | Small molecule | “risedronate, an orally administered third-generation bisphosphonate” PMID 23927913 ↗ Aug 2013 |
| Route | Oral | “Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.” NCT00043069 ↗ |
| Target | FDPS | “Farnesyl diphosphate synthase inhibitor” CHEMBL923 ↗ |