Axatilimab

Phase 2Monoclonal antibody

SSyndax Pharmaceuticals

Axatilimab is one of 227 small molecule programs targeting Lymphoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

226

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Chronic Graft Versus Host DiseaseRecruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Breast CancerActive, not recruiting

Idiopathic Pulmonary FibrosisActive, not recruiting

Advanced Malignant Solid NeoplasmRecruiting

Graft Versus Host DiseaseActive, not recruiting

LymphomaPhase 2

Active, not recruiting

Chronic Graft Versus Host DiseasePhase 2

Recruiting

Chronic Myelomonocytic LeukemiaPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Idiopathic Pulmonary FibrosisPhase 2

Active, not recruiting

Advanced Malignant Solid NeoplasmPreclinical

Recruiting

Graft Versus Host DiseasePhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Trodelvy

Gilead

Preclinical

37 2

Axatilimab

SSyndax Pharmaceuticals

Phase 2

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Spravato

WWim Janssens

Preclinical

2 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Chantix

PPrism Pharmaceuticals

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 10

Perflutren Lipid Microcpheres

TThomas Jefferson 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

Q2 2028

Phase 2Recruiting

Lymphoma

NCT05723055

Q4 2028

Phase 1/2Recruiting

Chronic Myelomonocytic Leukemia

NCT06523556

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

Breast Cancer2 trials

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

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

Recruiting·—·Phase 1·NCT06488378·20 enrolled

Chronic Myelomonocytic Leukemia2 trials

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·Phase 1/2·NCT07128381·66 enrolled

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Recruiting·UUma Borate·Phase 1/2·NCT06523556·52 enrolled

Immunotherapy2 trials

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

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

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

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

Graft Versus Host Disease1 trial

Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial

Not yet recruiting·MMayo Clinic·Phase 2·NCT07349771·72 enrolled

7 more indications

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

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

Idiopathic Pulmonary Fibrosis1 trial

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

Recruiting·SSyndax Pharmaceuticals·Phase 2·NCT06132256·135 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

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

Chronic Graft vs. Host Disease1 trial

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

Approved for marketing· Incyte logo

Incyte··NCT05544032

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 — 18 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

Q2 2028

Q4 2028

Trials by Indication[1]

Chronic Graft Versus Host Disease4 trials

Breast Cancer2 trials

Chronic Myelomonocytic Leukemia2 trials

Immunotherapy2 trials

Graft Versus Host Disease1 trial

Intravenous1 trial

Patients With Solid Tumors1 trial

Idiopathic Pulmonary Fibrosis1 trial

Phase 11 trial

Lymphoma1 trial

Chronic Graft vs. Host Disease1 trial

Advanced Malignant Solid Neoplasm1 trial

References

Drug Info

Quick Facts

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