velmanase alfa
Trade name: Lamzede
Recombinant proteinapprovedOrphan Drug FDAFast Track FDA
Approved
Feb 16, 2023
Clinical trial activity
10 trials · 6 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
8
Phase 3
5
Phase 4
0
Earliest trial started Oct 1, 2010 (NCT01268358)
Timeline
2000s
- Feb 2, 2006
Orphan Drug Designation
2010s
Indications
Approved for
Studied for
Mechanism of action
- High mannose oligosaccharidesHYDROLYTIC ENZYME
High mannose oligosaccharides hydrolytic enzyme
Degrades oligosaccharides in the lysosome, reducing their accumulation. Supplements or replaces natural enzyme.
- Alpha-mannosidaseSupplementation
Alpha-mannosidase supplementation
Approval history
- approvedPriority reviewFast trackFeb 16, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4298010 ↗
Also known as
- lamazym
- lamazym
- recombinant human alpha mannosidase
- rhlaman
- velmanase alfa
- velmanase alfa
- velmanase alfa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04031066 | Phase 3 | Jan 25, 2020 | Chiesi, University of California, San Francisco |
| NCT02998879 | Phase 2 | Dec 1, 2016 | Chiesi, Cromsource |
| NCT02478840 | Phase 3 | Feb 1, 2015 | University of Copenhagen, Zymenex |
| NCT01908712 | Phase 3 | Aug 1, 2013 | University of Copenhagen, Zymenex |
| NCT01908725 | Phase 3 | Jun 1, 2013 | University of Copenhagen, Zymenex |
| NCT01681953 | Phase 3 | Aug 1, 2012 | European Commission, University of Copenhagen, Zymenex |
| NCT01681940 | Phase 2 | Jan 1, 2012 | European Commission, University of Copenhagen, Zymenex |
| NCT01285700 | Phase 2 | Jan 1, 2011 | European Commission, University of Copenhagen, Zymenex |
| NCT01268358 | Phase 1 | Oct 1, 2010 | European Commission, University of Copenhagen, Zymenex |
| NCT04959240 | N/A | — | Chiesi |
Showing 10 of 10 trials
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Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| University of Copenhagen | Academic/Hospital | 7 | 0 | 3 | 2010 |
| Zymenex | For profit | 7 | 7 | 3 | 2010 |
| European Commission | Government | 4 | 0 | 3 | 2010 |
| Chiesi | For profit | 3 | 3 | 3 | 2016 |
| Cromsource | For profit | 1 | 0 | 1 | 2016 |
| University of California, San Francisco | Academic/Hospital | 1 | 0 | 1 | 2020 |
6 organizations
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