Sutimlimab
As of the edition of 20 October 2026, Sutimlimab is an antibody: marketed, first approved in 2022 (US); acts on C1S; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody
- Brand name
- Enjaymo
- First approved
- 4 February 2022 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Recordati Rare Diseases; 2 holders in all
- Registered trials
- 5, 0 stopped early
- Disease areas
- Blood and lymph; Immune system
US protection
US protection ends in 2034.
US protection ends in 2034, 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 Recordati Rare Diseases. 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 product2 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Sutimlimab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| C1S | Complement C1s subcomponent | P09871 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 2017 to now |
| Recordati Rare Diseases | Acquired holder | 2026 to now |