galsulfase
Trade name: Naglazyme
Recombinant proteinapprovedOrphan Drug FDA
Approved
May 31, 2005
Arylsulfatase B is an enzyme associated with mucopolysaccharidosis VI. — Wikipedia
Clinical trial activity
2 trials · 2 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
1
Earliest trial started May 1, 2006 (NCT00299000)
Timeline
Indications
Studied for
Mechanism of action
- Dermatan sulfateHYDROLYTIC ENZYME
Dermatan sulfate hydrolytic enzyme
To replace endogenous lysosomal enzymes required for the catabollism of GAG in case of mucopolysaccharide storage disorders
- N-acetylgalactosamine-4-sulfataseSupplementation
ARSB supplementation
Approval history
- approvedMay 31, 2005
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaArylsulfatase B ↗
- NCATS59UA429E5G ↗
- ChEMBLCHEMBL1201822 ↗
Also known as
- arsb
- arylsufatase b
- aryplase
- aryplase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase
- galsulfase (genetical recombination)
- naglazyme
- naglazyme
- naglazyme
- naglazyme
- naglazyme
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02156674 | N/A | Jan 1, 2016 | Biomarin, University of Minnesota |
| NCT00299000 | Phase 4 | May 1, 2006 | Biomarin |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biomarin | For profit | 2 | 1 | 2 | 2006 |
| University of Minnesota | Academic/Hospital | 1 | 1 | 1 | 2016 |
2 organizations
Page 1 / 1