Sutimlimab clinical trials
How each study uses sutimlimab is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 4 Feb 2022 · ENJAYMO · BLA 761164 (FDA, Drugs@FDA)
- European Union
- 15 Nov 2022 · Enjaymo · EMEA/H/C/005776 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
Studies by the year they started
4 studies that test it; most in 2018 (2)
| Year | Studies |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2021 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 4 · Other 0
Studies
Open first, then newest update. How each study uses sutimlimab is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 4
- Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in JapanCompletedPhase 3SanofiNCT05132127Written as sutimlimab
- A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)CompletedPhase 1Bioverativ, a Sanofi companyNCT03275454Written as BIVV009 6.5 grams
- A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood TransfusionCompletedPhase 3Bioverativ, a Sanofi companyNCT03347422Written as sutimlimab (BIVV009)
- A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)CompletedPhase 3Bioverativ, a Sanofi companyNCT03347396Written as BIVV009
Codes
What other systems call sutimlimab · ClinicalTrials.gg INT001157
- MeSH (NLM) C000634098sutimlimabConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) GNWE7KJ995SUTIMLIMABConfirmed FDA, NLM
- RxNorm 2591404One source FDA
- NCI Thesaurus C153093SutimlimabOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000634098 | sutimlimab | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | GNWE7KJ995 | SUTIMLIMAB | Confirmed FDA, NLM |
| RxNorm | 2591404 | — | One source FDA |
| NCI Thesaurus | C153093 | Sutimlimab | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.