nipocalimab
Trade name: Imaavy
mAbapprovedOrphan Drug FDA
Approved
Apr 29, 2025
Clinical trial activity
24 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
15
Phase 3
9
Phase 4
0
Earliest trial started Jun 1, 2016 (NCT02828046)
Timeline
2020s
- Jan 1, 2021
Earliest Phase 3 Sponsor(trial)
- Feb 11, 2021
Orphan Drug Designation
- Apr 29, 2025
Earliest FDA Approval
- Apr 29, 2025
Johnson and Johnson — Marketing Organization
Indications
Approved for
Studied for
- Anemia, Hemolytic, Autoimmune · Phase 2/Phase 3
- Arthritis, Rheumatoid · Phase 2
- Healthy Volunteers · Phase 1
- Lupus Erythematosus, Systemic · Phase 2
- Lupus Nephritis · Phase 2
- Myositis · Phase 2
- Neonatology · Phase 3
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 2/Phase 3
- Sjogren's Syndrome · Phase 3
- Thrombocytopenia, Neonatal Alloimmune · Phase 3
Mechanism of action
- IgG receptor FcRn large subunit p51ANTAGONIST
IgG receptor FcRn large subunit p51 antagonist
- IgG receptor FcRn large subunit p51INHIBITOR
FCGRT inhibitor
Approval history
- approvedPriority reviewApr 29, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4594310 ↗
Also known as
- m281
- m281
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07217587 | Phase 3 | Nov 28, 2025 | — |
| NCT06533098 | Phase 3 | Feb 5, 2025 | — |
| NCT06741969 | Phase 3 | Dec 4, 2024 | — |
| NCT06449651 | Phase 3 | Oct 1, 2024 | — |
| NCT05912517 | Phase 3 | Mar 9, 2024 | — |
| NCT06028438 | Phase 2 | Aug 15, 2023 | — |
| NCT05827874 | Phase 1 | Apr 12, 2023 | — |
| NCT05327114 | Phase 2/Phase 3 (Phase 3) | Sep 23, 2022 | — |
| NCT05265273 | Phase 2/Phase 3 (Phase 3) | Jul 20, 2022 | — |
| NCT05379634 | Phase 2 | Jul 5, 2022 | — |
| NCT05151692 | Phase 1 | Feb 14, 2022 | Janssen Pharmaceutica NV |
| NCT04883619 | Phase 2 | Jan 26, 2022 | Janssen Pharmaceutica NV |
| NCT04991753 | Phase 2 | Oct 14, 2021 | Janssen Pharmaceutica NV |
| NCT04968912 | Phase 2 | Sep 21, 2021 | Janssen Pharmaceutica NV |
| NCT04973566 | Phase 1 | Aug 31, 2021 | Janssen Pharmaceutica NV |
| NCT04882878 | Phase 2 | Aug 20, 2021 | Janssen Pharmaceutica NV |
| NCT04951622 | Phase 3 | Jul 15, 2021 | Janssen Pharmaceutica NV |
| NCT04848558 | Phase 1 | May 25, 2021 | Janssen Pharmaceutica NV |
| NCT04119050 | Phase 2/Phase 3 (Phase 3) | Oct 31, 2019 | Momenta Pharmaceuticals |
| NCT03896295 | Phase 2 | Jul 31, 2019 | Momenta Pharmaceuticals |
Showing 20 of 24 trials
Page 1 / 2
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Janssen Pharmaceutica NV | For profit | 8 | 8 | 3 | 2021 |
| Momenta Pharmaceuticals | For profit | 5 | 5 | 3 | 2016 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 1 | 0 | 1 | 2016 |
3 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Apr 29, 2025 |