Skip to main content

axatilimab

Generic: axatilimab·Brand: Niktimvo

axatilimab: sourced relationships with 1 company · 22 clinical trials tracked.

axatilimab evidence translation

What we can confirm

What it means

Source-backed records connect axatilimab to SNDX; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could axatilimab → SNDX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 1 study sponsors
Dated Pipeline Records (1)
CompanyDated record stage
Syndax Pharmaceuticals Inc (SNDX)
developer · Reported 2024-02-27 · Current development: unknownSource
Chronic Graft-versus-host-disease; Idiopathic Pulmonary Fibr…
Phase 2
Clinical Trial Registry Records (22)showing 10 most recent

Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)

NCT05544032Registry updated 2026-07-10·INCY
Approved for marketing
Expanded AccessIncyte Corporation

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients

NCT07511062Registry updated 2026-04-06·Phase 1
Not yet recruiting

Primary endpoint: Phase 2 Dose Level determination

Interventionalopen32 targetStarted 2026-08Completion 2030-081 site · United StatesNorthside Hospital, Inc.

IIT2024-02-SHIAO-ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation

NCT07015853Registry updated 2026-04-20·Phase 2
Not yet recruiting

Primary endpoint: Overall Response Rate (ORR)

Interventionalopen34 targetStarted 2026-06Completion 2033-071 site · United StatesStephen Shiao

A Phase 2, Randomized, Open-Label Study of 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)

NCT07124078Registry updated 2026-10-09·Phase 2·INCY
Recruiting

Primary endpoint: Objective Response (OR) at 6 months

InterventionalRandomizedopen60 targetStarted 2026-05Completion 2029-0741 sites · Belgium, Germany, Italy, Spain…Incyte Corporation

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

NCT07128381Registry updated 2026-10-09·Phase 1/Phase 2
Recruiting

Primary endpoint: Safety and Adverse Events (AEs)

Interventionalopen66 targetStarted 2026-01Completion 2033-071 site · United StatesM.D. Anderson Cancer Center

Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease

NCT07011810Registry updated 2026-09-24·Phase 2
Recruiting

Primary endpoint: Overall response rate (ORR) in sclerotic manifestations

Interventionalopen50 targetStarted 2025-08Completion 2030-023 sites · United StatesFred Hutchinson Cancer Center

A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After Systemic Therapy

NCT06843408Registry updated 2026-08-10·Phase 1/Phase 2·INCY
Active, not recruiting

Primary endpoint: Number of participants with Treatment-emergent Adverse Events (TEAEs)

Interventionalopen32 enrolledStarted 2025-06Completion 2028-079 sites · ChinaIncyte Corporation

A Phase 3, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

NCT06821542Registry updated 2026-08-25·Phase 3·INCY
Active, not recruiting

Primary endpoint: Objective Response (OR) at 6 months

InterventionalRandomizedopen9 enrolledStarted 2025-06Completion 2032-1150 sites · Austria, Belgium, Czechia, Finland…Incyte Corporation

A Phase II b Study of Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease

NCT06663722Registry updated 2026-06-22·Phase 2
Recruiting

Primary endpoint: Best Overall Response Rate (ORR)

Interventionalopen49 targetStarted 2025-05Completion 2030-053 sites · United StatesUniversity of Miami

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)

NCT06585774Registry updated 2026-10-09·Phase 3·INCY
Recruiting

Primary endpoint: Event Free Survival (EFS)

InterventionalRandomizedquadruple240 targetStarted 2025-01Completion 2030-03131 sites · Australia, Austria, Canada, Denmark…Incyte Corporation

Frequently asked questions

Which companies have sourced relationships with axatilimab?

axatilimab has dated SEC/FDA relationship records for Syndax Pharmaceuticals Inc.

How many clinical trials involve axatilimab?

BioSniper tracks 22 clinical trials involving axatilimab.