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axatilimab

Generic: axatilimab·Brand: Niktimvo

axatilimab: developed by 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
Development Pipeline (1)
CompanyPhase
Syndax Pharmaceuticals Inc (SNDX)
Chronic Graft-versus-host-disease; Idiopathic Pulmonary Fibr…
Phase 2
Clinical Trials (22)showing 10 most recent

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

Approved for marketing
Expanded AccessIncyte Corporation

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

NCT07511062·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

NCT07015853·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)

NCT07124078·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)

NCT07128381·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

NCT07011810·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

NCT06843408·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

NCT06821542·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

NCT06663722·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)

NCT06585774·Phase 3·INCY
Recruiting

Primary endpoint: Event Free Survival (EFS)

InterventionalRandomizedquadruple240 targetStarted 2025-01Completion 2030-0350 sites · Australia, Austria, Canada, United StatesIncyte Corporation

Frequently asked questions

Who is developing axatilimab?

axatilimab is being developed by Syndax Pharmaceuticals Inc.

How many clinical trials involve axatilimab?

BioSniper tracks 22 clinical trials involving axatilimab.