sibeprenlimab
Trade name: Voyxact
mAbapproved
Approved
Nov 25, 2025
Clinical trial activity
7 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
4
Phase 3
2
Phase 4
0
Earliest trial started Oct 23, 2018 (NCT03719443)
Timeline
Indications
Approved for
Mechanism of action
TNFSF13 inhibitor
Approval history
- approvedPriority reviewNov 25, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4594614 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06928142 | Phase 2 | Apr 23, 2025 | Otsuka |
| NCT06740526 | Phase 2 | Nov 19, 2024 | Otsuka |
| NCT07105124 | Phase 1 | Oct 18, 2022 | Otsuka |
| NCT05248659 | Phase 2/Phase 3 (Phase 3) | Mar 31, 2022 | Otsuka |
| NCT05248646 | Phase 3 | Mar 11, 2022 | Otsuka |
| NCT04287985 | Phase 2 | Mar 1, 2020 | Visterra, Inc. |
| NCT03719443 | Phase 1 | Oct 23, 2018 | Parexel, Visterra, Inc. |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Otsuka | For profit | 5 | 5 | 3 | 2022 |
| Visterra, Inc. | For profit | 2 | 2 | 2 | 2018 |
| Parexel | For profit | 1 | 0 | 1 | 2018 |
3 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Otsuka | For profit | MKTG | Nov 25, 2025 |