Drugs / Risedronate
Risedronate
also known as
Actonel · Risedronate Sodium · HMR4003 · ActonelR · NE-58095 · Optinate Septimum · Other name : Actonel(Risedronate 150mg)
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 55
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 5 met primary · 6 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT01575873 | Mar 2012 → Jun 2016 | corticosteroid-induced osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT00541658 | Oct 2007 → Apr 2010 | postmenopausal osteoporosis | Warner Chilcott | Completed | Met primary |
| Phase 3 | NCT00386360 | Apr 2006 → Sep 2009 | osteoporosis | Warner Chilcott | Completed | Missed primary |
| 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 | NCT00106028 | Nov 2004 → Apr 2008 | osteogenesis imperfecta | Warner Chilcott | Completed | Met primary |
| Phase 3 | NCT00138866 | Nov 2004 → Jan 2009 | osteoporosis | Toronto Rehabilitation Institute | 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 | Missed primary Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT00043069 | Nov 2002 → Jun 2006 | osteoporosis, prostate cancer | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| Phase 3 | NCT00619957 | Jun 2002 → May 2007 | osteoporosis | Warner Chilcott | Completed | Met primary |
| 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 | Missed primary |
| Phase 418 trials · 1 met primary | ||||||
| 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 | NCT00453492 | Jan 2004 → ? | postmenopausal osteoporosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00372372 | Jan 2004 → Apr 2007 | osteoporosis | Tuen Mun Hospital | 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 | Met primary |
| Phase 4 | NCT00402441 | Sep 2002 → Jun 2004 | postmenopausal 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 Stop: Enrollment |
| — | NCT00567606 | Apr 2002 → Dec 2007 | postmenopausal osteoporosis | University of Nebraska | Completed | No outcome recorded |
| Comparator or background therapy33 trials | ||||||
| Phase 1 | NCT00868907 Comparator | Mar → Apr 2009 | — | Warner Chilcott | Completed | No outcome recorded |
| 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 2/3 | NCT02063854 Comparator | Feb 2014 → Nov 2015 | osteoporosis | Takeda | Completed | Missed primary |
| Phase 2/3 | NCT00089843 Comparator | Jun 2003 → Apr 2008 | anorexia nervosa | Massachusetts General Hospital | Completed | No outcome recorded |
| 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 | NCT00503399 Comparator | Jul 2007 → Oct 2010 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00343252 Comparator | Jun 2006 → Jun 2009 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | Missed primary |
| 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 4 | NCT03411902 Comparator | Jun 2018 → Jul 2020 | disease of bone structure | Wake Forest University Health Sciences | Completed | 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-03-19 | Eisai Inc. | Regulatory All-case Surveillance Condition for Approval of “Actonel® 17.5 mg tablets” for Treatment of Paget’s Disease of Bone Cleared in Japan eisai.com ↗ |
| 2018-12-05 | Upsher-Smith Laboratories | Regulatory MHLW Approves New Indication for RISEDRONATE Tablets and DOBUTAMINE I.V. Infusion upsher-smith.com ↗
This approval expands the indication of RISEDRONATE SODIUM Tablets 17.5 mg [SAWAI] and DOBUTAMINE HYDROCHLORIDE I.V. Infusion 100 mg [SAWAI] to include the same uses as their brand equivalents. |
| 2018-09-13 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Risedronate Sodium Delayed-Release Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Risedronate Sodium Delayed-Release Tablets (US RLD – ATELVIA ® delayed-release tablets), 35 mg . |
| 2017-11-09 | Eli Lilly and Company | Results New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis lilly.com ↗
Results from the study's primary endpoint showed that at 24 months, fewer patients taking FORTEO® had new vertebral fractures as compared to patients taking risedronate (5.4% vs. 12.0%, p <0.0001). |
| 2016-08-29 | Amgen | Results Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia® (Denosumab) In Patients Receiving Glucocorticoid Therapy amgen.com ↗
Amgen (NASDAQ: AMGN) today announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia ® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. |
| 2012-12-25 | Eisai Inc. | Regulatory Approval of a Once-Monthly Formulation of Risedronate Sodium Hydrate,an Antiosteoporotic Agent in Japan eisai.com ↗
has been approved by the Ministry of Health, Labour and Welfare in Japan. |
| 2008-07-16 | Eisai Inc. | Regulatory Antiosteoporotic drugs “Actonel® 17.5 mg tablets” and “Benet® 17.5 mg tablets” received approval for additional indication in patients with Paget's disease of bone: Both come in new packages. eisai.com ↗
Ajinomoto Co., Inc. (“Ajinomoto”, President and CEO: Norio Yamaguchi, Headquarters: Tokyo) and Takeda Pharmaceutical Company Limited (“Takeda”, President: Yasuchika Hasegawa, Headquarters: Osaka) are pleased to announce that the Ministry of Health, Labour and Welfare (MHLW) has approved the additional indication of “Actonel® 17.5 mg tablets” and “Benet® 17.5 mg tablets” (generic name: risedronate sodium hydrate) for Paget's disease of bone. |
| 2007-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Generic Actonel® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg. |
| 2007-04-18 | Eisai Inc. | Regulatory A ONCE-WEEKLY FORMULATION OF RISEDRONATE SODIUM HYDRATE, AN ANTIOSTEOPOROTIC AGENT, WAS APPROVED. eisai.com ↗
the Ministry of Health, Labour and Welfare approved today “Actonel® 17.5 mg tablets” and “Benet® 17.5 mg tablets” |
| 2005-08-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Risedronate Sodium Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Risedronate Sodium Tablets, 5 mg, 30 mg and 35 mg. |
All press releases naming this drug 15 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 90 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 | 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 ↗9“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 | HMR4003 | “risedronate (HMR4003)” NCT00353080 ↗ |
| Known as | NE-58095 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02063854 ↗ |
| 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 | 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)” NCT00106028 ↗ “Risedronate Sodium (Actonel)” NCT00549068 ↗ |
| Action | Inhibit | “Their major action is to prevent bone breakdown by stopping the normal process of removing and then replacing old bone tissue” NCT03208582 ↗ |
| 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 ↗ |