olipudase alfa
Trade name: Xenpozyme
Recombinant proteinapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Aug 31, 2022
Clinical trial activity
4 trials · 2 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Dec 1, 2013 (NCT02004704)
Timeline
2000s
- Aug 3, 2000
Orphan Drug Designation
2010s
2020s
- Aug 31, 2022
Sanofi-Aventis — Earliest FDA Approval
- Aug 31, 2022
Genzyme — Marketing Organization
- Aug 31, 2022
Sanofi-Aventis — NDA Secondary Org
- Aug 31, 2022
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
- SphingomyelinHYDROLYTIC ENZYME
Sphingomyelin hydrolytic enzyme
- Neutral sphingomyelinaseSupplementation
SMPD2 supplementation
Approval history
- approvedFast trackBreakthroughAug 31, 2022
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
- ChEMBLCHEMBL3707358 ↗
Also known as
- gz402665
- gz-402665
- olipudase alfa
- olipudase alfa
- olipudase alfa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02004691 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2015 | Genzyme, Sanofi |
| NCT02292654 | Phase 1/Phase 2 (Phase 2) | May 1, 2015 | Genzyme, Sanofi |
| NCT02004704 | Phase 2 | Dec 1, 2013 | Genzyme, Sanofi |
| NCT04877132 | N/A | — | Sanofi |
Showing 4 of 4 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 4 | 1 | 3 | 2013 |
| Genzyme | For profit | 3 | 3 | 2 | 2013 |
2 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Genzyme | For profit | MKTG | Aug 31, 2022 |
| Sanofi-Aventis | For profit | NDA2 | Aug 31, 2022 |
| Sanofi-Aventis | For profit | NDA | Aug 31, 2022 |