elosulfase alfa
Trade name: vimizim
Recombinant proteinapprovedOrphan Drug FDAFast Track FDA
Approved
Feb 14, 2014
Elosulfase alfa, sold under the brand name Vimizim, is a medication used for the treatment of Morquio syndrome which is caused by a deficiency in the enzyme N-acetylgalactosamine-6-sulfatase. Elosulfase alfa is a synthetic version of this enzyme. — Wikipedia
Clinical trial activity
9 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
8
Phase 3
3
Phase 4
0
Earliest trial started Apr 1, 2009 (NCT00884949)
Timeline
Indications
Approved for
Studied for
Mechanism of action
- Chondroitin-6-sulfateHYDROLYTIC ENZYME
Chondroitin-6-sulfate hydrolytic enzyme
- Keratan sulfateHYDROLYTIC ENZYME
Keratan sulfate hydrolytic enzyme
- N-acetylgalactosamine-6-sulfataseSupplementation
GALNS supplementation
Approval history
- approvedFast trackFeb 14, 2014
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 warningFirst in class
Sources
- WikipediaElosulfase alfa ↗
- NCATSODJ69JZG85 ↗
- ChEMBLCHEMBL2108676 ↗
Also known as
- bmn-100
- bmn 110
- bmn 110
- bmn 110
- bmn-110
- ec 3.1.6.4
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- elosulfase alfa
- galactosamine (n-acetyl)-6-sulfate sulfatase, human
- galactose-6-sulfate sulfatase, human
- galnac6s protein, human
- galns protein, human
- morquio syndrome protein, human
- mucopolysaccharidosis type iva protein, human
- n-acetylgalactosamine-6-sulfatase
- n-acetylgalactosamine-6-sulfatase, human
- rhgalns
- vimizim
- vimizim
- vimzim
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01966029 | Phase 3 | Jul 1, 2013 | Biomarin |
| NCT01858103 | N/A | May 15, 2013 | Biomarin |
| NCT01697319 | Phase 2 | Aug 1, 2012 | Biomarin |
| NCT01609062 | Phase 2 | Apr 1, 2012 | Biomarin |
| NCT01515956 | Phase 2 | Oct 1, 2011 | Biomarin |
| NCT01415427 | Phase 3 | Jul 1, 2011 | Biomarin |
| NCT01275066 | Phase 3 | Feb 1, 2011 | Biomarin |
| NCT01242111 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2010 | Biomarin |
| NCT00884949 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2009 | Biomarin |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biomarin | For profit | 9 | 9 | 3 | 2009 |
1 organizations
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