Nipocalimab
As of the edition of 20 October 2026, Nipocalimab is an antibody: marketed, first approved in 2025 (US); acts on FCGRT; US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Antibody
- Brand name
- Imaavy
- First approved
- 29 April 2025 (US)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Registered trials
- 25, 2 stopped early
- Disease areas
- Immune system; Nervous system; Skin and connective tissue; Bones, joints and muscles; Cancer; Eye
US protection
US protection ends in 2037.
US protection ends in 2037, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Johnson & Johnson. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Nipocalimab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FCGRT | IgG receptor FcRn large subunit p51 | P55899 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 9 | 6 | 1 | 2 |
| Phase 3 | 9 | 0 | 9 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2016 to now |