Axatilimab · Niktimvo, SNDX-6352

What is Axatilimab?

Axatilimab-csfr is a humanized monoclonal antibody that binds to colony stimulating factor-1 receptor (CSF-1R) on monocytes and macrophages. By blocking CSF-1R, it reduces circulating pro-inflammatory and pro-fibrotic monocytes and inhibits pathogenic macrophage activity.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Niktimvo, SNDX-6352, UCB-6352

Drug type

Monoclonal antibody

Targets

colony stimulating factor-1 receptor (CSF1R)

Mechanism

Antagonist of colony stimulating factor-1 receptor (CSF1R)

Pathways

macrophage inhibition, reduction of pro-inflammatory cytokines, TGF-beta signaling inhibition

Therapy area

Respiratory

Developer

Incyte Corp

In trials of

SNDX

FDA status

Approved as Niktimvo (August 14, 2024), BLA761411 · FDA label

UNII

R96Z451BMC

✅ FDA-approved uses

• Chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy

From the indications section of the FDA label (version of Jun 24, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Idiopathic Pulmonary FibrosisUnresectable Intrahepatic Cholangiocarcinoma

Other drugs acting on CSF1R

Sources

• FDA Purple Book
• FDA label (DailyMed)
• FDA label Niktimvo (2026-06-24), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT04301778
• ClinicalTrials.gov NCT06132256

Updated Oct 3, 2026.