technetium-99m bicisate

Small moleculeapprovedImaging agent

Approved

Nov 23, 1994

Technetium Tc 99m Bicisate is a Radioactive Diagnostic Agent indicated as an adjunct to conventional computed tomography (CT) or magnetic resonance imaging (MRI) in the localization of stroke in patients in whom stroke has already been diagnosed. Technetium Tc 99m Bicisate is a lipophilic complex with high first-pass extraction fraction and deposition and retention in the brain in proportion to cerebral blood flow. Its radionuclide emissions permit external imaging of the cerebral distribution of the agent, thus allowing the detection of altered regional cerebral perfusion. The retention in the brain of technetium Tc 99m Bicisate results from in vivo metabolism (de-esterification) of the primary complex to polar, less diffusable compounds Technetium Tc-99m Bicisate is metabolized by endogenous enzymes to the mono- and di-acids of Technetium Tc-99m Bicisate that can be detected in blood and urine. Technetium Tc-99m Bicisate is excreted primarily through the kidneys. Within two hours, 50% of the injected dose is excreted and by 24 hours, 74% is found in urine. — NCATS

Clinical trial activity

4 trials · 6 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
2
Phase 3
2
Phase 4
0

Earliest trial started Nov 1, 2009 (NCT01013727)

Timeline

1990s

  1. Nov 23, 1994

    Lantheus Medical Imaging — Earliest FDA Approval

  2. Nov 23, 1994

    Lantheus Medical Imaging — NDA Secondary Org

  3. Nov 23, 1994

    Lantheus Medical Imaging — NDA Organization

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedNov 23, 1994

Chemistry & pharmacology

Loading structure…

SMILES

[O--].[Tc+5].CCOC(=O)[C@H](C[S-])NCC[N-][C@@H](C[S-])C(=O)OCC
Mol. weight
435.44 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
99-technetium

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 99mtc-ecd
  • 99mtc ethyl cysteinate dimer
  • 99mtc ethyl cysteinate dimer
  • 99mtc ethyl cysteinate dimer
  • 99mtc ethylcysteinate dimer
  • du pont brand of technetium tc 99m bicisate
  • neurolite
  • neurolite
  • neurolite
  • neurolite
  • neurolite
  • tc-99m-bicisate
  • tc-99m ecd
  • tc-99m-ecd
  • tc-99m-l,l-ecd
  • tc-ethyl cysteinate dimer
  • technegas
  • technetium-99m bicisate
  • technetium (99mtc) bicisate
  • technetium (99mtc) bicisate
  • technetium bicisate
  • technetium tc 99m bicisate
  • technetium tc 99m bicisate
  • technetium tc 99m bicisate
  • technetium tc-99m bicisate kit
  • technetium tc-99m bicisate kit
  • technetium tc 99m ethyl cysteine dimer

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03054870Phase 3Apr 1, 2017Certus International, Cyclomedica Australia PTY Limited
NCT02513992N/AMay 1, 2016Katholieke Universiteit Leuven
NCT01458639Phase 3Aug 1, 2012Certus International, Columbia University, Cyclomedica Australia PTY Limited, Washington University in St. Louis
NCT01013727N/ANov 1, 2009University of Strasbourg
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Certus InternationalFor profit2012012
Cyclomedica Australia PTY LimitedFor profit2212012
Columbia UniversityAcademic/Hospital1012012
Katholieke Universiteit LeuvenAcademic/Hospital1112016
University of StrasbourgAcademic/Hospital1112009
Washington University in St. LouisAcademic/Hospital1012012
6 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Lantheus Medical ImagingFor profitNDA2Nov 23, 1994
Lantheus Medical ImagingFor profitNDANov 23, 1994