pamidronate

Trade name: aredia

Small moleculeapproved

Approved

Oct 31, 1991

Pamidronic acid (Pamidronate Disodium) is a bone resorption inhibitor. The principal pharmacologic action of pamidronate disodium is inhibition of bone resorption. Although the mechanism of antiresorptive action is not completely understood, several factors are thought to contribute to this action. Pamidronate disodium adsorbs to calcium phosphate (hydroxyapatite) crystals in bone and may directly block dissolution of this mineral component of bone. In vitro studies also suggest that inhibition of osteoclast activity contributes to inhibition of bone resorption. In animal studies, at doses recommended for the treatment of hypercalcemia, pamidronate disodium inhibits bone resorption apparently without inhibiting bone formation and mineralization. Of relevance to the treatment of hypercalcemia of malignancy is the finding that pamidronate disodium inhibits the accelerated bone resorption that results from osteoclast hyperactivity induced by various tumors in animal studies. Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. Pamidronate disodium is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. — NCATS

Clinical trial activity

34 trials · 43 clinical orgs · 17 marketing orgs

Phase 1
7
Phase 2
15
Phase 3
4
Phase 4
11

Earliest trial started Mar 1, 1998 (NCT00083408)

Timeline

1990s

  1. Oct 31, 1991

    Earliest FDA Approval

  2. Oct 31, 1991

    Novartis — NDA Secondary Org

  3. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  4. Sep 22, 1998

    Novartis — First NDA Organization

  5. Sep 22, 1998

    Novartis — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  3. Apr 30, 2001

    West-Ward Pharmaceutical — NDA Secondary Org

  4. Mar 4, 2002

    Hikma — Marketing Organization

  5. Mar 4, 2002

    Hikma — NDA Secondary Org

  6. Mar 27, 2002

    Teva — Marketing Organization

  7. May 6, 2002

    Aesgen — Marketing Organization

  8. May 6, 2002

    Fresenius — Marketing Organization

  9. Jun 27, 2002

    Hospira — Marketing Organization

  10. Jul 25, 2008

    Sankyo — Marketing Organization

  11. Jul 25, 2008

    Lutipold — Marketing Organization

  12. Jul 25, 2008

    Daiichi Sankyo — Marketing Organization

  13. Aug 19, 2008

    Pliva — Marketing Organization

  14. Aug 19, 2008

    Dr. Reddy's Laboratories — Marketing Organization

  15. Oct 31, 2008

    Mylan — Marketing Organization

  16. Nov 26, 2008

    Areva Med LLC — Marketing Organization

  17. Dec 23, 2008

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  18. Dec 24, 2008

    Sun Pharmaceuticals — Marketing Organization

  19. Mar 10, 2009

    MN Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewOct 31, 1991

Chemistry & pharmacology

Loading structure…

SMILES

NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Mol. weight
249.1 g/mol
Lipinski Ro5
1 violation(s)
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

  • 1-hydroxy-3-aminopropane-1,1-diphosphonic acid
  • (3-amino-1-hydroxypropylidene)-1,1-biphosphonate
  • (3-amino-1-hydroxypropylidene)-1,1-bisphosphonate
  • acide pamidronique
  • acide pamidronique
  • acido pamidronico
  • acido pamidronico
  • acidum pamidronicum
  • acidum pamidronicum
  • ahprbp
  • alendronate monosodium salt trihydrate
  • alendronate monosodium salt trihydrate
  • alendronate monosodium salt trihydrate
  • alendronate monosodium salt trihydrate
  • alendronate monosodium salt trihydrate
  • alendronate monosodium salt trihydrate
  • alendronate sodium hydrate
  • alendronate sodium hydrate
  • alendronate sodium hydrate
  • alendronate sodium trihydrate
  • amidronate
  • amino-1-hydroxypropane-1,1-diphosphonate
  • aminohydroxybutane bisphosphonate
  • aminohydroxypropylidene diphosphonate
  • aminopropanehydroxydiphosphonate
  • apd
  • aredia
  • aredia
  • aredia
  • aredia
  • cgp-23339ae
  • cgp-23339ae
  • disodium pamidronate
  • disodium pamidronate
  • novartis brand of pamidronate disodium salt
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate
  • pamidronate calcium
  • pamidronate disodium
  • pamidronate disodium
  • pamidronate disodium
  • pamidronate disodium
  • pamidronate disodium
  • pamidronate disodium hydrate
  • pamidronate monosodium
  • pamidronic acid
  • pamidronic acid
  • pamidronic acid
  • pamidronic acid
  • pamidronic acid
  • pamidronic acid
  • ribodroat
  • ribodroat

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02721433Phase 4Aug 1, 2016University of Ottawa
NCT02594878Phase 2Oct 1, 2015Aarhus University
NCT02544659Phase 1Oct 1, 2015Tsinghua University
NCT02074631Phase 2Feb 1, 2015University of Minnesota
NCT02313727Phase 4Dec 1, 2014Bnai Zion Medical Center, Johnson and Johnson
NCT02101164Phase 4Nov 1, 2014Amgen
NCT01799616Phase 2Jan 1, 2013University Clermont Auvergne
NCT01718951Phase 4Aug 1, 2012Tuen Mun Hospital, Hong Kong
NCT01907880Phase 4Aug 1, 2012Canadian Breast Cancer Foundation, University of Ottawa
NCT01067989Phase 2Mar 1, 2010Emek Medical Center
NCT02007915N/AJul 1, 2009University of Toronto
NCT00680953Phase 3May 1, 2008Daiichi Sankyo
NCT00548288Phase 1Nov 1, 2007General and Teaching Hospital Celje
NCT00655681N/ASep 1, 2007Thrasher Research Fund, University of New Mexico
NCT00262392N/AJun 1, 2005Freie Medizinische Gesellschaft, University of Basel, University of Bern
NCT00124605Phase 1Apr 1, 2005City of Hope National Medical Center, National Cancer Institute (NCI)
NCT00482378Phase 1/Phase 2 (Phase 2)Mar 1, 2005Mayo Clinic, National Cancer Institute (NCI)
NCT01210599Phase 1/Phase 2 (Phase 2)Apr 1, 2004Icahn School of Medicine at Mount Sinai, Yeshiva University
NCT00101790Phase 1Sep 1, 2003Icahn School of Medicine at Mount Sinai, National Institute of Neurological Disorders and Stroke (NINDS)
NCT00108394Phase 4Oct 1, 2002Department of Veteran Affairs
Showing 20 of 34 trials
Page 1 / 2

Organizations

Research & Development (43)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government5231999
NovartisFor profit4112000
City of Hope National Medical CenterAcademic/Hospital2121999
Hoosier Cancer Research NetworkAcademic/Hospital2211998
Icahn School of Medicine at Mount SinaiAcademic/Hospital2122003
Mayo ClinicAcademic/Hospital2122002
University of BarcelonaAcademic/Hospital2112000
University of OttawaAcademic/Hospital2212012
Aarhus UniversityAcademic/Hospital1112015
AmgenFor profit1112014
Bnai Zion Medical CenterAcademic/Hospital1112014
Canadian Breast Cancer FoundationAcademic/Hospital1012012
Daiichi SankyoFor profit1112008
Department of Veteran AffairsGovernment1112002
Emek Medical CenterAcademic/Hospital1112010
Freie Medizinische GesellschaftAcademic/Hospital1012005
General and Teaching Hospital CeljeAcademic/Hospital1112007
Indiana UniversityAcademic/Hospital1111999
Johnson and JohnsonFor profit1012014
Monash UniversityAcademic/Hospital1112002
43 organizations
Page 1 / 3

Marketing (21)

OrganizationOrg typeRelationshipDate
AesgenFor profitMKTGMay 6, 2002
Areva Med LLCFor profitMKTGNov 26, 2008
Daiichi SankyoFor profitMKTGJul 25, 2008
Dr. Reddy's LaboratoriesFor profitMKTGAug 19, 2008
FreseniusFor profitMKTGMay 6, 2002
HikmaFor profitSYNApr 30, 2001
HikmaFor profitMKTGMar 4, 2002
HikmaFor profitNDA2Mar 4, 2002
HospiraFor profitMKTGJun 27, 2002
LutipoldFor profitMKTGJul 25, 2008
MN PharmaceuticalsFor profitMKTGMar 10, 2009
MylanFor profitMKTGOct 31, 2008
NovartisFor profitNDA2Oct 31, 1991
NovartisFor profitNDASep 22, 1998
PlivaFor profitMKTGAug 19, 2008
Sagent Pharmaceuticals, Inc.For profitMKTGDec 23, 2008
Sagent Pharmaceuticals, Inc.For profitSYNDec 23, 2008
SankyoFor profitMKTGJul 25, 2008
Sun PharmaceuticalsFor profitMKTGDec 24, 2008
TevaFor profitMKTGMar 27, 2002
West-Ward PharmaceuticalFor profitNDA2Apr 30, 2001