sutimlimab
Trade name: Enjaymo
Approved
Feb 4, 2022
Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD). It is given by intravenous infusion. Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro. — Wikipedia
Clinical trial activity
4 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started Aug 8, 2017 (NCT03275454)
Timeline
2010s
- Jul 27, 2016
Orphan Drug Designation
- Jan 1, 2017
Sanofi-Aventis — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
Bioverativ Therapeutics Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- Feb 4, 2022
Sanofi-Aventis — Earliest FDA Approval
- Feb 4, 2022
Bioverativ Therapeutics Inc. — Marketing Organization
- Feb 4, 2022
Sanofi-Aventis — NDA Secondary Org
- Feb 4, 2022
Sanofi-Aventis — NDA Organization
Indications
Mechanism of action
- Complement C1sANTAGONIST
C1S antagonist
- Complement C1sINHIBITOR
Complement C1s inhibitor
Approval history
- approvedBreakthroughFeb 4, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaSutimlimab ↗
- ChEMBLCHEMBL4297832 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05132127 | Phase 3 | Nov 14, 2021 | Sanofi |
| NCT03347396 | Phase 3 | Nov 20, 2017 | Bioverativ Therapeutics Inc. |
| NCT03347422 | Phase 3 | Nov 20, 2017 | Bioverativ Therapeutics Inc. |
| NCT03275454 | Phase 1 | Aug 8, 2017 | Sanofi-Aventis |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bioverativ Therapeutics Inc. | For profit | 2 | 2 | 1 | 2017 |
| Sanofi | For profit | 1 | 1 | 1 | 2021 |
| Sanofi-Aventis | For profit | 1 | 1 | 1 | 2017 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bioverativ Therapeutics Inc. | For profit | MKTG | Feb 4, 2022 |
| Sanofi-Aventis | For profit | NDA2 | Feb 4, 2022 |
| Sanofi-Aventis | For profit | NDA | Feb 4, 2022 |