technetium tc-99m medronate kit

Small moleculeapprovedImaging agent

Approved

Dec 16, 1977

Clinical trial activity

3 trials · 7 clinical orgs · 5 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
1
Phase 4
1

Earliest trial started Mar 1, 2010 (NCT00956163)

Timeline

1970s

  1. Dec 16, 1977

    Pharmalucence — Earliest FDA Approval

  2. Dec 16, 1977

    Pharmalucence — NDA Secondary Org

  3. Dec 16, 1977

    Pharmalucence — NDA Organization

  4. Nov 28, 1978

    Jubilant DraxImage Inc. — NDA Secondary Org

  5. Nov 28, 1978

    Jubilant DraxImage Inc. — Marketing Organization

  6. Jun 26, 1979

    General Electric — NDA Secondary Org

  7. Aug 29, 1979

    Sun Pharmaceuticals — Marketing Organization

  8. Aug 29, 1979

    Sun Pharmaceuticals — NDA Secondary Org

1980s

  1. Feb 17, 1981

    Cardinal Health — NDA Secondary Org

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

  • BoneBINDING AGENT

    Bone binding agent

Approval history

  • approvedDec 16, 1977

Chemistry & pharmacology

Mol. weight
290.91 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
99-technetium

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 99m tc medronate
  • 99m tc medronate
  • 99m tc-medronate
  • 99m tc-medronate
  • 99mtc medronate
  • 99mtc medronate
  • 99mtc-medronate
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  • 99mtc-medronate
  • amerscan mdp kit
  • an-mdp
  • an-mdp
  • an-mdp
  • cis-mdp
  • cis-mdp
  • cis-mdp
  • draximage mdp-10
  • draximage mdp-25
  • draximage mdp-25
  • draximage mdp-25
  • mdp-bracco
  • mdp-bracco
  • mdp kit
  • mdp kit
  • osteolite
  • osteolite
  • osteolite
  • osteolite
  • oxidronic acid 99mtc-complex
  • oxidronic acid 99mtc-complex
  • tc 99m mdp
  • tc 99m mdp
  • tc-99m mdp
  • tc-99m mdp
  • tc-99m mdp
  • tc 99m methylene diphosphonate
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  • technescan
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  • technescan hdp
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  • technetium (99mtc) medronic acid
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  • technetium (99mtc) methylenediphosphonate
  • technetium (99mtc) methylenediphosphonate
  • technetium (99mtc) methylenediphosphonate
  • technetium (99mtc) methylenediphosphonate for injection
  • technetium (99mtc) oxidronate
  • technetium (99mtc) oxidronate
  • technetium 99mtc oxidronate
  • technetium 99mtc oxidronate
  • technetium (99mtc) oxidronic acid
  • technetium methylene diphosphonate
  • technetium methylene diphosphonate
  • technetium tc 99m medronate
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  • technetium tc 99m medronic acid
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  • technetium tc 99m mpi mdp
  • technetium tc 99m mpi mdp
  • technetium tc 99m mpi mdp

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03107247Phase 4Aug 1, 2017Harvard University, Johns Hopkins University, National Institutes of Health (NIH), University of Florida
NCT01930812Phase 3Apr 1, 2014British Columbia Cancer Agency, Canadian Institutes of Health Research (CIHR)
NCT00956163Early Phase 1 (Phase 1)Mar 1, 2010Harvard University, National Cancer Institute (NCI)
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital2122010
British Columbia Cancer AgencyAcademic/Hospital1112014
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012014
Johns Hopkins UniversityAcademic/Hospital1012017
National Cancer Institute (NCI)Government1112010
National Institutes of Health (NIH)Government1012017
University of FloridaAcademic/Hospital1012017
7 organizations
Page 1 / 1

Marketing (8)

OrganizationOrg typeRelationshipDate
Cardinal HealthAcademic/HospitalNDA2Feb 17, 1981
General ElectricFor profitNDA2Jun 26, 1979
Jubilant DraxImage Inc.For profitNDA2Nov 28, 1978
Jubilant DraxImage Inc.For profitMKTGNov 28, 1978
PharmalucenceFor profitNDA2Dec 16, 1977
PharmalucenceFor profitNDADec 16, 1977
Sun PharmaceuticalsFor profitMKTGAug 29, 1979
Sun PharmaceuticalsFor profitNDA2Aug 29, 1979