Friday, July 10, 2026

Drug profile · INN

axatilimab-csfr

axatilimab-csfr (NIKTIMVO) is a macrophage colony stimulating factor receptor inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 1
Congress events 1
Drug details — axatilimab-csfr

Quick answer

axatilimab-csfr (NIKTIMVO) is a macrophage colony stimulating factor receptor inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN axatilimab-csfr
Brand NIKTIMVO
Mechanism Macrophage colony stimulating factor receptor inhibitor
Target Macrophage colony-stimulating factor 1 receptor
Route INTRAVENOUS
Formulation INJECTABLE

Mechanism of action

Macrophage colony stimulating factor receptor inhibitor

Primary target: Macrophage colony-stimulating factor 1 receptor

Approval history

Authority Status Date
FDA approved

Recent coverage

Congress & event coverage

  • Presentation
    EULAR 2026

    1 presentation · immunology

Pipeline programs

  1. AXATILIMAB Phase 2 · Syndax Pharmaceuticals · Chronic graft versus host disease (cGVHD)
  2. Axatilimab Phase 2 · Syndax Pharmaceuticals · Chronic Graft-versus-host-disease
  3. Axatilimab Phase 2 · Syndax Pharmaceuticals · Idiopathic Pulmonary Fibrosis
  4. Axatilimab Phase 1 · Syndax Pharmaceuticals · Solid Tumor

Related & competitor drugs

  1. sunitinib malate Vascular endothelial growth factor receptor inhibitor
  2. pexidartinib hydrochloride Tyrosine-protein kinase receptor FLT3 inhibitor
  3. pexidartinib Antineoplastic and immunomodulating agents (L01)
  4. quizartinib Antineoplastic and immunomodulating agents (L01)
  5. sunitinib Antineoplastic and immunomodulating agents (L01)
  6. axatilimab Macrophage colony stimulating factor receptor inhibitor

Frequently asked questions

What is axatilimab-csfr?

axatilimab-csfr (NIKTIMVO) is a macrophage colony stimulating factor receptor inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for axatilimab-csfr?

NIKTIMVO is a marketed brand name for axatilimab-csfr. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of axatilimab-csfr?

axatilimab-csfr has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.