Overview
Sacrosidase is a liquid enzyme preparation from S.cerevisiae used for the treatment of congenital sucrose-isomaltase deficiency (CSID). People with CSID have variable amounts of sucrose-isomaltase enzyme activity and therefore have issues metabolizing dietary disaccharide sucrose causing chronic or intermittent watery diarrhea in infants and children. Treatment options for these patients are limited and usually consists of a lifelong sucrose-free diet; therefore, sacrosidase offers a potential alternative for symptom relief.
Indication
For the treatment of congenital sucrose-isomaltase deficiency (CSID).
Associated Conditions
- Sucrase-isomaltase deficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/27 | Phase 2 | Completed | |||
2016/05/26 | Phase 4 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| QOL Medical, LLC | 67871-111 | ORAL | 8500 [iU] in 1 mL | 12/15/2023 |
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. | |||||
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