Sutimlimab

PreclinicalMonoclonal antibody

Sutimlimab is a monoclonal antibody that works as a C1s Complement Inhibitor.[2] It is being investigated across 1 indication, with its most advanced program in Preclinical.[1]

Sutimlimab is one of 12 monoclonal antibody programs targeting Cold Agglutinin Disease. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cold Agglutinin DiseaseUnknown

Cold Agglutinin DiseasePreclinical

Unknown

Competition

Competitive Landscape

13 competitors in Cold Agglutinin Disease

#DrugCompanyPhaseTrials

Tazverik

EEpizyme, Inc.

Phase 3

1 2

Empaveli

Apellis Pharmaceuticals

Phase 3

1 3

Fludara

Sanofi

Phase 2

1 4

Soliris

AstraZeneca

Phase 2

1 5

Rituxan

Roche

Phase 2

1 6

Velcade

SShilpa Grover, MD, MPH

Phase 2

1 7

Brukinsa

BBeOne Medicines

Phase 2

1 8

BIVV009

BBioverativ, a Sanofi company

Phase 3

1 9

APL-2

Apellis Pharmaceuticals

Phase 2

1 10

SAR445088

BBioverativ, a Sanofi company

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Recruiting

Cold Agglutinin Disease

NCT05791708

Clinical

Trials by Indication[1]

Cold Agglutinin Disease3 trials

Cold Agglutinin Disease Real World Evidence Registry

Recruiting·RRECORDATI GROUP··NCT05791708·400 enrolled

Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan

Completed· Sanofi logo

Sanofi·Phase 3·NCT05132127·7 enrolled

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

Completed·BBioverativ, a Sanofi company·Phase 3·NCT03347422·42 enrolled

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Sutimlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sutimlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sutimlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 1 publication indexed for Sutimlimab. U.S. National Library of Medicine.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: C1s Complement Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Preclinical[1]
Company: Sanofi

Key Publications[4]

Sutimlimab in Cold Agglutinin Disease: CARDINAL 2-Year

BloodApr 6, 2023DOI: 10.1182/blood.2022019543

Sutimlimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Cold Agglutinin Disease3 trials

References

Drug Info

Quick Facts

Key Publications[4]

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