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Niktimvo (AXATILIMAB)
Niktimvo blocks the Colony Stimulating Factor-1 Receptor to reduce inflammation and prevent damage to healthy tissues.
At a glance
| Generic name | AXATILIMAB |
|---|---|
| Sponsor | Incyte Corp |
| Drug class | Colony Stimulating Factor-1 Receptor Blocker [EPC] |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Axatilimab-csfr is a monoclonal antibody that binds to colony stimulating factor-1 receptors (CSF-1R) expressed on monocytes and macrophages. Blocking CSF-1R with axatilimab-csfr reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages, as demonstrated by a reduction of nonclassical monocyte counts in nonclinical studies with axatilimab-csfr, and inhibits the activity of pathogenic macrophages in tissues.
Approved indications
- chronic graft-versus-host disease (cGVHD)
Common side effects
- Infection (pathogen unspecified)
- Viral infection
- Musculoskeletal pain
- Fatigue
- Bacterial infection
- Pyrexia
- Dyspnea
- Nausea
- Diarrhea
- Cough
- Headache
- Increased AST
Key clinical trials
- Axatilimab for Sclerotic Chronic Graft-versus-Host Disease (PHASE2)
- MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (PHASE3)
- A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (PHASE2)
- Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Niktimvo CI brief — competitive landscape report
- Niktimvo updates RSS · CI watch RSS
- Incyte Corp portfolio CI