Axatilimab

Phase 2Monoclonal antibody

SSyndax Pharmaceuticals

Axatilimab is one of 219 small molecule programs targeting Immunotherapy. It is currently in Phase 2.

Indications

Total Trials

Active Trials

218

Competitors

Pipeline

Status by Indication[3][1]

Indication

ImmunotherapyNot yet recruiting

Advanced Malignant Solid NeoplasmRecruiting

Chronic Graft Versus Host DiseaseActive, not recruiting

Myelofibrosis，mfRecruiting

Atypical Chronic Myeloid LeukemiaRecruiting

LymphomaRecruiting

Breast CancerRecruiting

Idiopathic Pulmonary FibrosisRecruiting

ImmunotherapyPhase 2

Not yet recruiting

Advanced Malignant Solid NeoplasmPreclinical

Recruiting

Chronic Graft Versus Host DiseasePhase 2

Active, not recruiting

Myelofibrosis，mfPreclinical

Recruiting

Atypical Chronic Myeloid LeukemiaPreclinical

Recruiting

LymphomaPhase 2

Recruiting

Breast CancerPhase 1

Recruiting

Idiopathic Pulmonary FibrosisPhase 2

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Axatilimab

SSyndax Pharmaceuticals

Phase 2

2 2

Adenocard

Astellas

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Acupan

YYonsei University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Idiopathic Pulmonary Fibrosis

NCT06132256

Phase 2Active, not recruiting

Immunotherapy

NCT05491226

Q3 2027

Phase 2Active, not recruiting

Chronic Graft Versus Host Disease

NCT04710576

Q4 2027

Not yet recruiting

Chronic Graft Vs. Host Disease

NCT07728708

Q2 2028

Phase 2Recruiting

Lymphoma

NCT05723055

Clinical

Trials by Indication[1]

Chronic Graft Versus Host Disease4 trials

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Active, not recruiting·SSyndax Pharmaceuticals·Phase 2·NCT04710576·241 enrolled

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Recruiting· Incyte logo

Incyte·Phase 2·NCT06388564·120 enrolled

Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT07011810·50 enrolled

Show 1 more trial

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

Recruiting·UUniversity of Miami·Phase 2·NCT06663722·49 enrolled

Immunotherapy2 trials

ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation

Not yet recruiting·SStephen Shiao·Phase 2·NCT07015853·34 enrolled

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Active, not recruiting·SStephen Shiao·Phase 2·NCT05491226·35 enrolled

Breast Cancer2 trials

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Recruiting·DDana-Farber Cancer Institute·Phase 1·NCT06488378·20 enrolled

A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06959537·24 enrolled

Chronic Graft vs. Host Disease2 trials

Mapping On-Target Effects of Axatilimab in Human Chronic Graft-versus-Host Disease Skin: A Prospective Observational Mechanistic Study

Not yet recruiting·NNorthwestern University··NCT07728708·15 enrolled

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

Approved for marketing· Incyte logo

Incyte··NCT05544032

Lymphoma1 trial

Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Recruiting·UUniversity of Utah·Phase 2·NCT05723055·9 enrolled

9 more indications

Idiopathic Pulmonary Fibrosis1 trial

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting·SSyndax Pharmaceuticals·Phase 2·NCT06132256·135 enrolled

Patients With Solid Tumors1 trial

A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

Completed·SSyndax Pharmaceuticals·Phase 1·NCT03238027·45 enrolled

Intravenous1 trial

A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

Completed· Incyte logo

Incyte·Phase 1·NCT06713590·72 enrolled

Phase 11 trial

A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

Completed·SSyndax Pharmaceuticals·Phase 1/2·NCT03604692·41 enrolled

Graft Versus Host Disease1 trial

Phase II Open-Label, Randomized-Controlled Trial of CSF-1R Inhibitor, Axatilimab, for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell Transplantation

Not yet recruiting·MMedical College of Wisconsin·Phase 2·NCT07808112·72 enrolled

Hematopoietic and Lymphatic System Neoplasm1 trial

Phase II Double-Blinded Placebo-Controlled Randomized Trial of CSF-1R Inhibitor, Axatilimab for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell Transplantation (ABRAXAS)

Withdrawn·MMayo Clinic·Phase 2·NCT07349771

Atypical Chronic Myeloid Leukemia1 trial

Phase 1b/2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN/MDS Overlap or High-Risk CMML

Recruiting·UUma Borate·Preclinical·NCT06523556·49 enrolled

Myelofibrosis，MF1 trial

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)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07128381·66 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors

Recruiting·OOHSU Knight Cancer Institute·Preclinical·NCT06320405·38 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Axatilimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Axatilimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Axatilimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Syndax Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 2[1]
Company: SSyndax Pharmaceuticals

Axatilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Chronic Graft Versus Host Disease4 trials

Immunotherapy2 trials

Breast Cancer2 trials

Chronic Graft vs. Host Disease2 trials

Lymphoma1 trial

Idiopathic Pulmonary Fibrosis1 trial

Patients With Solid Tumors1 trial

Intravenous1 trial

Phase 11 trial

Graft Versus Host Disease1 trial

Hematopoietic and Lymphatic System Neoplasm1 trial

Atypical Chronic Myeloid Leukemia1 trial

Myelofibrosis，MF1 trial

Advanced Malignant Solid Neoplasm1 trial

References

Drug Info

Quick Facts

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