sacrosidase
Trade name: sucraid
Approved
Apr 9, 1998
Sacrosidase is a medication used to replace sucrase in people lacking this enzyme. It is available as an oral solution. Sucraid is approved by the U.S. Food and Drug Administration (FDA) for the therapy of the genetically determined sucrase deficiency that is part of the Congenital Sucrase-Isomaltase Deficiency (CSID). Sacrosidase assists in the breakdown of sugar/sucrose into simpler forms and is useful for the relief of gastrointestinal symptoms that are associated with CSID. — Wikipedia
Clinical trial activity
4 trials · 2 clinical orgs · 2 marketing orgs
Earliest trial started May 1, 2016 (NCT02784067)
Timeline
1990s
- Dec 10, 1993
Orphan Drug Designation
- Apr 9, 1998
Orphan Medical — Earliest FDA Approval
- Apr 9, 1998
Orphan Medical — NDA Organization
- Apr 9, 1998
QOL Medical, LLC — NDA Secondary Org
2020s
- Jan 1, 2022
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- SucroseHYDROLYTIC ENZYME
Sucrose hydrolytic enzyme
Replaces endogenous human sucrase in case of congenital sucrase-isomaltase deficiency (CSIS)
- Glucosyltransferase-ISupplementation
gtfB supplementation
Approval history
- approvedApr 9, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaSacrosidase ↗
- NCATS8A7F670F2Y ↗
- ChEMBLCHEMBL1201487 ↗
Also known as
- sacrosidase
- sacrosidase
- sacrosidase
- sacrosidase
- sacrosidase
- sacrosidase
- sacrosidase
- sacrosidase
- sucraid
- sucraid
- sucraid
- sucraid
- sucrase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05703009 | Phase 2 | Jun 5, 2023 | QOL Medical, LLC |
| NCT05480761 | Phase 4 | Aug 1, 2022 | QOL Medical, LLC |
| NCT04604275 | Phase 2 | Jan 1, 2022 | QOL Medical, LLC, University of Miami |
| NCT02784067 | Phase 4 | May 1, 2016 | QOL Medical, LLC |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| QOL Medical, LLC | For profit | 4 | 3 | 2 | 2016 |
| University of Miami | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Orphan Medical | For profit | NDA | Apr 9, 1998 |
| QOL Medical, LLC | For profit | NDA2 | Apr 9, 1998 |