Axatilimab

Orphan Drug Cold Chain RequiredFDA Approved (2024)

Description

An anti-CSF1R monoclonal antibody for chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. FDA-approved August 2024.

Indications & Therapeutic Use

Chronic graft-versus-host disease

Linked Diseases:

graft-versus-host disease
T86.0D006086

Evidence: FDA-approved indication

Global Availability (1 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus
Approved

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
Axatilimab
Generic Nameaxatilimab
Brands1 brand available
Active Ingredientaxatilimab
Drug ClassChronic graft-versus-host disease
ManufacturerIncyte / Syndax
Dosage FormsOral capsule
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Reg. StatusFDA Approved (2024)
Clinical TrialNCT05117931
Countries1 countries
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes