avalglucosidase alfa
Trade name: Nexviazyme
Recombinant proteinapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Aug 6, 2021
Clinical trial activity
7 trials · 2 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
3
Phase 3
3
Phase 4
2
Earliest trial started Jul 1, 2013 (NCT01898364)
Timeline
2010s
2020s
- Aug 6, 2021
Sanofi-Aventis — Earliest FDA Approval
- Aug 6, 2021
Genzyme — Marketing Organization
- Aug 6, 2021
Sanofi-Aventis — NDA Secondary Org
- Aug 6, 2021
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
- Alpha-glucosidaseAGONIST
Alpha-glucosidase agonist
- GlycogenHYDROLYTIC ENZYME
Glycogen hydrolytic enzyme
Approval history
- approvedPriority reviewFast trackBreakthroughAug 6, 2021
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
- ChEMBLCHEMBL4594320 ↗
Also known as
- gz402666
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06666413 | Phase 4 | Mar 27, 2025 | Genzyme |
| NCT05164055 | Phase 4 | Feb 15, 2022 | Genzyme, Sanofi |
| NCT04910776 | Phase 3 | Sep 1, 2021 | Sanofi |
| NCT03019406 | Phase 2 | Jul 1, 2017 | Genzyme, Sanofi |
| NCT02782741 | Phase 3 | Oct 19, 2016 | Sanofi |
| NCT02032524 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2014 | Genzyme, Sanofi |
| NCT01898364 | Phase 1 | Jul 1, 2013 | Genzyme, Sanofi |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 6 | 2 | 4 | 2013 |
| Genzyme | For profit | 5 | 5 | 4 | 2013 |
2 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Genzyme | For profit | MKTG | Aug 6, 2021 |
| Sanofi-Aventis | For profit | NDA2 | Aug 6, 2021 |
| Sanofi-Aventis | For profit | NDA | Aug 6, 2021 |