Overview
Gadoxetic acid (gadoxetate) is a paramagnetic gadolinium-containing contrast agent in which its salt form, gadoxetate disodium, is used for intravenous injection. Ethoxybenzyl diethylenetriaminepentaacetic acid is the moiety that chelates with a gadolinium ion and forms a stable complex with it to make up the drug. It is marketed by Bayer HealthCare Pharmaceuticals and FDA approved on July 3, 2008.
Background
Gadoxetic acid (gadoxetate) is a paramagnetic gadolinium-containing contrast agent in which its salt form, gadoxetate disodium, is used for intravenous injection. Ethoxybenzyl diethylenetriaminepentaacetic acid is the moiety that chelates with a gadolinium ion and forms a stable complex with it to make up the drug. It is marketed by Bayer HealthCare Pharmaceuticals and FDA approved on July 3, 2008.
Indication
Gadoxetate is used as a contrast medium for magnetic resonance imaging (MRI) to detect and characterize lesions in the liver.
Associated Conditions
- Chronic Liver Diseases (CLD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/07/22 | Phase 4 | Terminated | |||
2020/05/04 | Phase 4 | Recruiting | |||
2019/05/23 | Early Phase 1 | UNKNOWN | |||
2017/07/12 | Phase 4 | Withdrawn | Slawa Cwajna | ||
2015/10/19 | Phase 1 | Completed | |||
2015/05/01 | Phase 4 | Completed | |||
2015/03/24 | N/A | Completed | |||
2014/06/05 | Not Applicable | Active, not recruiting | |||
2014/03/12 | Phase 3 | Terminated | |||
2013/10/24 | Early Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bayer HealthCare Pharmaceuticals Inc. | 50419-320 | INTRAVENOUS | 181.43 mg in 1 mL | 3/27/2015 |
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 |
|---|---|---|---|---|---|
| Gadoxetic Acid Disodium Injection | 国药准字H20213742 | 化学药品 | 注射剂 | 9/24/2021 | |
| Gadoxetic Acid Disodium Injection | 国药准字HJ20150178 | 化学药品 | 注射剂 | 1/15/2024 | |
| Gadoxetic Acid Disodium Injection | 国药准字H20193162 | 化学药品 | 注射剂 | 6/6/2019 | |
| Gadoxetic Acid Disodium Injection | 国药准字H20244108 | 化学药品 | 注射剂 | 6/25/2024 | |
| Gadoxetic Acid Disodium Injection | 国药准字HJ20150175 | 化学药品 | 注射剂 | 1/15/2024 |
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. | |||||