rozanolixizumab
Trade name: RYSTIGGO
mAbapprovedOrphan Drug FDA
Approved
Jun 26, 2023
Clinical trial activity
26 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
16
Phase 3
14
Phase 4
1
Earliest trial started Jul 1, 2014 (NCT02220153)
Timeline
2010s
Indications
Approved for
Mechanism of action
- IgG receptor FcRn large subunit p51ANTAGONIST
FCGRT antagonist
- IgG receptor FcRn large subunit p51INHIBITOR
IgG receptor FcRn large subunit p51 inhibitor
Approval history
- approvedPriority reviewJun 26, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4297820 ↗
Also known as
- ucb7665
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07246564 | Phase 4 | Dec 31, 2025 | UCB |
| NCT06720714 | Phase 1 | Dec 4, 2024 | UCB |
| NCT06540144 | Phase 3 | Oct 8, 2024 | UCB |
| NCT06456528 | Phase 2/Phase 3 (Phase 3) | Jul 31, 2024 | Qilu Pharmaceutical Co., Ltd. |
| NCT06149559 | Phase 2/Phase 3 (Phase 3) | Jan 31, 2024 | UCB |
| NCT05681715 | Phase 3 | Apr 17, 2023 | UCB |
| NCT05643794 | Phase 2 | Dec 12, 2022 | UCB |
| NCT05554913 | Phase 2/Phase 3 (Phase 3) | Sep 30, 2022 | Qilu Pharmaceutical Co., Ltd. |
| NCT05063162 | Phase 3 | Nov 26, 2021 | UCB |
| NCT04875975 | Phase 2 | Sep 27, 2021 | UCB |
| NCT04828343 | Phase 1 | Apr 22, 2021 | UCB |
| NCT04650854 | Phase 3 | Jan 31, 2021 | UCB |
| NCT05851027 | Phase 2/Phase 3 (Phase 3) | Jan 15, 2021 | Qilu Pharmaceutical Co., Ltd. |
| NCT04596995 | Phase 3 | Dec 31, 2020 | UCB |
| NCT04224688 | Phase 3 | Jan 31, 2020 | UCB |
| NCT04200456 | Phase 3 | Dec 31, 2019 | UCB |
| NCT04124965 | Phase 3 | Oct 31, 2019 | UCB |
| NCT05621330 | Phase 3 | Oct 18, 2019 | Qilu Pharmaceutical Co., Ltd. |
| NCT04051944 | Phase 2 | Aug 31, 2019 | UCB |
| NCT03971422 | Phase 3 | Jun 30, 2019 | UCB |
Showing 20 of 26 trials
Page 1 / 2
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| UCB | For profit | 19 | 19 | 5 | 2019 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 4 | 4 | 1 | 2019 |
| Hoosier Cancer Research Network | Academic/Hospital | 3 | 3 | 2 | 2014 |
| Parexel | For profit | 2 | 0 | 2 | 2014 |
4 organizations
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