Sutimlimab

Summary

Sutimlimab (CHEMBL4297832) is an approved antibody (ATC L04AJ04) targeting C1S; indicated across 4 conditions including autoimmune hemolytic anemia and autoimmune thrombocytopenic purpura.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AJ04
• Targets: 1 (C1S)
• Indications: 4 conditions
• Clinical trials: 5

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297832
Name	Sutimlimab
Type	Antibody
Max phase	4
ATC	L04AJ04

Also known as: Bivv-009, BIVV009, Enjaymo, Sutimlimab, Sutimlimab jome, Sutimlimab-jome, TNT-009, TNT009, SUTIMLIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
C1S	complement C1s	Binding	9.59	0.8%	P09871

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): C1S.

Top Reactome pathways

8 total, by targets touching each:

Pathway	Targets	Genes
Complement cascade	1	C1S
Initial triggering of complement	1	C1S
Creation of C4 and C2 activators	1	C1S
Innate Immune System	1	C1S
Immune System	1	C1S
Classical antibody-mediated complement activation	1	C1S
Regulation of Complement cascade	1	C1S
Dengue virus activates/modulates innate and adaptive immune responses	1	C1S

Dominant GO biological processes

GO term	Targets
proteolysis	1
complement activation, classical pathway	1
innate immune response	1
immune system process	1
complement activation	1

Indications & clinical

Indications

4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
autoimmune hemolytic anemia	4	MONDO:0020108	EFO:1001264
autoimmune thrombocytopenic purpura	1	MONDO:0008558	EFO:0007160

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 5.

Phase distribution

Phase	Trials
PHASE3	3
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03347396	PHASE3	COMPLETED	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)
NCT03347422	PHASE3	COMPLETED	A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
NCT05132127	PHASE3	COMPLETED	Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
NCT03275454	PHASE1	COMPLETED	A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)
NCT05791708	Not specified	ACTIVE_NOT_RECRUITING	Cold Agglutinin Disease Real World Evidence Registry

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

1 molecules share ≥1 primary target. Top 1 by shared-target count:

Molecule	Source	Status	Shared targets
NAFAMOSTAT	ChEMBL	Phase 3	C1S