Overview
Benznidazole was granted accelerated approval for the treatment of Chagas disease in children 2-12 years of age by the FDA on August 29, 2017. It is the first treatment made available in the United States for Chagas disease.
Indication
For use in the treatment of Chagas disease in children 2-12 years of age .
Associated Conditions
- Chagas' Disease caused by Typanosoma cruzi
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/09 | Phase 2 | Recruiting | |||
2024/04/01 | Phase 3 | Withdrawn | Evandro Chagas Institute of Clinical Research | ||
2022/08/31 | Phase 1 | Active, not recruiting | |||
2021/05/21 | Phase 3 | Recruiting | |||
2019/07/18 | Phase 3 | Active, not recruiting | Insud Pharma | ||
2019/06/11 | Phase 2 | Completed | University of Texas, El Paso | ||
2019/03/27 | Phase 1 | Completed | Drugs for Neglected Diseases | ||
2018/09/14 | Phase 3 | Active, not recruiting | Tulane University School of Public Health and Tropical Medicine | ||
2017/12/20 | Phase 2 | UNKNOWN | Drugs for Neglected Diseases | ||
2017/06/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Exeltis USA, Inc. | 0642-7463 | ORAL | 12.5 mg in 1 1 | 11/10/2023 | |
| Exeltis USA, Inc. | 0642-7464 | ORAL | 100 mg in 1 1 | 11/10/2023 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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