Overview
Technetium Tc-99m sestamibi (commonly sestamibi) is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands, hence the name sesta (6) MIBI.. Following intravenous injection of the drug, Technetium Tc-99m sestamibi is taken up by the myocardium, parathyroid, and/or breast tissue. The mechanism by which sestamibi localizes to these tissues has not been established. Single photon emission computed tomography (SPECT) is then performed to detect the gamma ray emmitted by the decay of Technetium-99m to Technetium-99. Currently available within a preparation kit for injection, Technetium Tc 99m Sestamibi is indicated for: 1) detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects); and 2) evaluating myocardial function and developing information for use in patient management decisions.
Background
Technetium Tc-99m sestamibi (commonly sestamibi) is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands, hence the name sesta (6) MIBI.. Following intravenous injection of the drug, Technetium Tc-99m sestamibi is taken up by the myocardium, parathyroid, and/or breast tissue. The mechanism by which sestamibi localizes to these tissues has not been established. Single photon emission computed tomography (SPECT) is then performed to detect the gamma ray emmitted by the decay of Technetium-99m to Technetium-99. Currently available within a preparation kit for injection, Technetium Tc 99m Sestamibi is indicated for: 1) detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects); and 2) evaluating myocardial function and developing information for use in patient management decisions.
Indication
Technetium Tc 99m Sestamibi is indicated for: 1) detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects); and 2) evaluating myocardial function and developing information for use in patient management decisions.
Associated Conditions
- Coronary Artery Disease (CAD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/09/13 | Not Applicable | Recruiting | |||
2017/02/27 | Phase 4 | Terminated | Medstar Health Research Institute | ||
2016/08/16 | Not Applicable | Completed | Central Hospital, Nancy, France | ||
2016/04/20 | Early Phase 1 | Active, not recruiting | |||
2014/12/24 | Not Applicable | Active, not recruiting | |||
2013/08/19 | Not Applicable | Completed | |||
2008/02/21 | Not Applicable | Completed | |||
2005/09/13 | Phase 4 | Completed | |||
2005/09/13 | Phase 4 | Completed | |||
2005/09/13 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Jubilant Draximage (USA) Inc. | 45548-141 | INTRAVENOUS | 1 mg in 1 mL | 8/13/2017 | |
| Sun Pharmaceutical Industries, Inc. | 45567-0555 | INTRAVENOUS | 1 mg in 10 mL | 3/31/2020 | |
| Cardinal Health 414, LLC | 65857-500 | PARENTERAL | 1 mg in 5 mL | 11/16/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sestamibi for Injection | 国药准字H19990038 | 化学药品 | 注射剂 | 8/13/2020 | |
| Technetium[99mTc] Sestamibi Injection | 国药准字H19994149 | 化学药品 | 注射剂 | 2/5/2020 | |
| Technetium[99mTc] Sestamibi Injection | 国药准字H10973070 | 化学药品 | 注射剂 | 7/28/2020 | |
| Technetium[99mTc] Sestamibi Injection | 国药准字H10973065 | 化学药品 | 注射剂 | 2/23/2023 | |
| Technetium[99mTc] Sestamibi Injection | 国药准字H10973049 | 化学药品 | 注射剂(小容量注射剂) | 2/26/2021 | |
| Technetium[99mTc] Sestamibi Injection | 国药准字H10973068 | 化学药品 | 注射剂 | 7/1/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||