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risedronate

Trade name: actonel

Small moleculeapproved

Approved

Mar 27, 1998

Risedronic acid is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. The action of risedronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Risedronate also targets farnesyl pyrophosphate (FPP) synthase. It is FDA approved for the treatment of postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis and Paget’s disease. Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of Risedronic acid. Common adverse reactions include rash, abdominal pain, constipation, diarrhea, indigestion, nausea, backache, urinary tract infectious disease and influenza-like illness. — NCATS

Clinical trial activity

108 trials · 105 clinical orgs · 19 marketing orgs

Phase 1
9
Phase 2
50
Phase 3
42
Phase 4
35

Earliest trial started Aug 1, 1999 (NCT00268632)

Timeline

1990s

  1. Mar 27, 1998

    Procter and Gamble — Earliest FDA Approval

  2. Mar 27, 1998

    Allergan — NDA Secondary Org

  3. Mar 27, 1998

    Procter and Gamble — NDA Organization

  4. Mar 27, 1998

    SmithKline Beecham — NDA Secondary Org

  5. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Warner Chilcott — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  3. Aug 12, 2005

    Warner Chilcott — Marketing Organization

  4. Aug 12, 2005

    Warner Chilcott — NDA Secondary Org

  5. Oct 5, 2007

    Teva — Marketing Organization

2010s

  1. Oct 8, 2010

    GlaxoSmithKline — NDA Secondary Org

  2. Jun 10, 2014

    Apotex — Marketing Organization

  3. Jun 10, 2014

    Mylan — Marketing Organization

  4. Jun 10, 2014

    Sun Pharmaceuticals — Marketing Organization

  5. Jun 10, 2014

    PHARMOBEDIENT — Marketing Organization

  6. Nov 30, 2015

    Aurobindo Pharma — Marketing Organization

  7. Dec 9, 2015

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  8. Dec 9, 2015

    Neogen — Marketing Organization

  9. Jan 29, 2016

    Orchid Pharma — Marketing Organization

  10. Jun 29, 2018

    Impax Laboratories — Marketing Organization

  11. Jun 29, 2018

    Amneal Pharmaceuticals — Marketing Organization

  12. Sep 11, 2018

    Zydus Discovery DMCC — Marketing Organization

  13. Feb 15, 2019

    Minsheng Binjiang Pharmaceuticals — Marketing Organization

  14. May 13, 2019

    Orbion Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMar 27, 1998

Chemistry & pharmacology

Loading structure…

SMILES

O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Mol. weight
283.11 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-(3-pyridinyl)-2-hydroxyethylidene-1,1-bisphosphonate
  • acide risédroniqe
  • acide risédroniqe
  • acido risedronico
  • acido risedronico
  • acidum risedronicum
  • acidum risedronicum
  • actonel
  • actonel
  • actonel
  • actonel
  • atelvia
  • atelvia
  • ne 58095
  • ne-58095
  • ne-58095
  • ne-58095
  • ne-58095
  • phosphonic acid, (2-hydroxy-2-(3-pyridinyl)ethylidene)bis-, disodium salt
  • residronate
  • ridron
  • ridron
  • risedronate
  • risedronate
  • risedronate
  • risedronate
  • risedronate
  • risedronate
  • risedronate
  • risedronate sodium
  • risedronate sodium
  • risedronate sodium
  • risedronate sodium
  • risedronate sodium anhydrous
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hemi-pentahydrate
  • risedronate sodium hydrate
  • risedronate sodium monohydrate
  • risedronic acid
  • risedronic acid
  • risedronic acid
  • risedronic acid
  • risedronic acid
  • risedronic acid monohydrate
  • risedronic acid monosodium salt
  • risedronsäure
  • risedronsäure
  • risendronate
  • sodium risedronate
  • sodium risedronate
  • sodium risedronate
  • sodium risedronate hydrate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07242612N/AOct 1, 2025Khyber Medical University Peshawar
NCT05630768Phase 4Nov 30, 2022Dong-A Pharmaceutical
NCT04922333Phase 3Jul 31, 2022Wake Forest University
NCT05346419N/AJul 1, 2021Hospital Regional 10 de Octubre, ISSSTE, National Autonomous University of Mexico, National Polytechnic Institute, Mexico, Regional Hospital October 1st
NCT04152551Phase 4Nov 30, 2019Cornell University, Northwell Health, Rockefeller University, The New York Community Trust
NCT03861091Phase 2Jul 31, 2019Wake Forest University
NCT03411902Phase 4Jun 15, 2018Wake Forest University
NCT02317458Phase 3Jun 1, 2017Celyad
NCT03208582Phase 2Apr 1, 2017Sheffield Hallam University, University of Sheffield
NCT02744482Phase 3May 1, 2016University of Limoges
NCT02186600Phase 3Feb 1, 2015Creighton University, University of Nebraska
NCT02063854Phase 2/Phase 3 (Phase 3)Feb 1, 2014EA Pharma Co., Ltd., Takeda
NCT01923610Phase 1Sep 1, 2013University of Barcelona
NCT02148848Phase 4Jun 1, 2013Mahidol University, Siriraj Hospital
NCT01904110Phase 4Dec 1, 2012Hanlim Pharm. Co., Ltd., Sungkyunkwan University
NCT01709110Phase 4Oct 1, 2012Eli Lilly
NCT01665417Phase 4Aug 1, 2012Betta Pharmaceuticals Co.,Ltd., Hebei University, Peking University, People's Liberation Army of China, Tsinghua University
NCT02429596Phase 4May 1, 2012IRCCS National Neurological Institute C. Mondino Foundation
NCT02592161Phase 2Apr 1, 2012Korea Health Industry Development Institute
NCT01575873Phase 3Mar 28, 2012Amgen
Showing 20 of 108 trials
Page 1 / 6

Organizations

Research & Development (105)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Procter and GambleFor profit32051999
SanofiFor profit301541999
Warner ChilcottFor profit171742001
Eli LillyFor profit4422006
Hanlim Pharm. Co., Ltd.For profit3322009
Harvard UniversityAcademic/Hospital3222003
Mayo ClinicAcademic/Hospital3012002
National Cancer Institute (NCI)Government3212002
Wake Forest UniversityAcademic/Hospital3332018
Alliance for Better Bone HealthAcademic/Hospital2022003
AmgenFor profit2212009
Chung-Ang UniversityAcademic/Hospital2022009
Cornell UniversityAcademic/Hospital2112005
MerckFor profit2212002
NovartisFor profit2212001
RocheFor profit2122005
Sheffield Hallam UniversityAcademic/Hospital2212007
TakedaFor profit2212006
University of AlbertaAcademic/Hospital2222002
University of NebraskaAcademic/Hospital2222002
105 organizations
Page 1 / 6

Marketing (24)

OrganizationOrg typeRelationshipDate
AllerganFor profitNDA2Mar 27, 1998
Amneal PharmaceuticalsFor profitMKTGJun 29, 2018
ApotexFor profitMKTGJun 10, 2014
ApotexFor profitSYNJun 10, 2014
Aurobindo PharmaFor profitMKTGNov 30, 2015
Aurobindo PharmaFor profitSYNOct 21, 2016
GlaxoSmithKlineFor profitNDA2Oct 8, 2010
Impax LaboratoriesFor profitMKTGJun 29, 2018
Macleods Pharmaceuticals, LtdFor profitMKTGDec 9, 2015
Minsheng Binjiang PharmaceuticalsFor profitMKTGFeb 15, 2019
MylanFor profitMKTGJun 10, 2014
MylanFor profitSYNJun 10, 2014
NeogenFor profitMKTGDec 9, 2015
Orbion PharmsFor profitMKTGMay 13, 2019
Orchid PharmaFor profitMKTGJan 29, 2016
PHARMOBEDIENTFor profitMKTGJun 10, 2014
Procter and GambleFor profitNDAMar 27, 1998
SmithKline BeechamFor profitNDA2Mar 27, 1998
Sun PharmaceuticalsFor profitMKTGJun 10, 2014
Sun PharmaceuticalsFor profitSYNJun 10, 2014
TevaFor profitMKTGOct 5, 2007
Warner ChilcottFor profitMKTGAug 12, 2005
Warner ChilcottFor profitNDA2Aug 12, 2005
Zydus Discovery DMCCFor profitMKTGSep 11, 2018