technetium-99m bicisate
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
Earliest trial started Nov 1, 2009 (NCT01013727)
Timeline
1990s
- Nov 23, 1994
Lantheus Medical Imaging — Earliest FDA Approval
- Nov 23, 1994
Lantheus Medical Imaging — NDA Secondary Org
- Nov 23, 1994
Lantheus Medical Imaging — NDA Organization
2010s
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- contrast mediumRadiopaque
contrast medium radiopaque
Approval history
- approvedNov 23, 1994
Chemistry & pharmacology
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
- ChEMBLCHEMBL2110558 ↗
- NCATSH25WJA31XE ↗
- ChEMBLCHEMBL5314650 ↗
- ChEMBLCHEMBL4597194 ↗
- ChEMBLCHEMBL2096659 ↗
- ChEMBLCHEMBL1237111 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03054870 | Phase 3 | Apr 1, 2017 | Certus International, Cyclomedica Australia PTY Limited |
| NCT02513992 | N/A | May 1, 2016 | Katholieke Universiteit Leuven |
| NCT01458639 | Phase 3 | Aug 1, 2012 | Certus International, Columbia University, Cyclomedica Australia PTY Limited, Washington University in St. Louis |
| NCT01013727 | N/A | Nov 1, 2009 | University of Strasbourg |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Certus International | For profit | 2 | 0 | 1 | 2012 |
| Cyclomedica Australia PTY Limited | For profit | 2 | 2 | 1 | 2012 |
| Columbia University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of Strasbourg | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Washington University in St. Louis | Academic/Hospital | 1 | 0 | 1 | 2012 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Lantheus Medical Imaging | For profit | NDA2 | Nov 23, 1994 |
| Lantheus Medical Imaging | For profit | NDA | Nov 23, 1994 |