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Axatilimab

Alternative Names: axatilimab, sndx-6352, sndx6352, sndx 6352, INCA-034176, INCA 034176, INCA034176
Latest Update: 2025-04-23
Latest Update Note: Clinical Trial Update

Product Description

Syndax is developing Axatilimab as a treatment for chronic Graft-versus-host-disease (cGVHD). (Sourced from: https://clinicaltrials.gov/ct2/show/NCT04710576)

Mechanisms of Action: CSF-1R Antagonist

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intravenous

FDA Designation:
Orphan Drug - Graft vs Host Disease
Orphan Drug - Idiopathic Pulmonary Fibrosis|Pulmonary Fibrosis
Priority Review - Graft vs Host Disease *

Approval Status: Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Incyte
Company Location: WILMINGTON DE 19803
Company CEO: Hervé Hoppenot
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Axatilimab

Countries in Clinic: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Netherlands, Poland, Portugal, Singapore, Spain, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 21

Highest Development Phases

Phase 3: Bronchiolitis Obliterans|Graft vs Host Disease

Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Chronic, Atypical, BCR-ABL Negative Myeloid Leukemia|Hodgkin Lymphoma|Idiopathic Pulmonary Fibrosis|Juvenile Myelomonocytic Leukemia,|Myelodysplastic-Myeloproliferative Diseases|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Oncology Solid Tumor Unspecified|Triple Negative Breast Cancer

Phase 1: Breast Cancer|Healthy Volunteers

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
NCT06663722

P2

Not yet recruiting

Graft vs Host Disease|Bronchiolitis Obliterans

2030-04-15

jRCT2031240468

P3

Not yet recruiting

Graft vs Host Disease

2030-03-31

INCA34176-357

P3

Recruiting

Graft vs Host Disease

2030-03-31

INCA34176-254

P2

Recruiting

Graft vs Host Disease

2030-01-31

Recent News Events

Date

Type

Title

04/04/2025

News Article

 Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

04/02/2025

News Article

 Syndax Announces Participation at the Stifel 2025 Virtual Targeted Oncology Forum

03/05/2025

News Article

 Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

02/28/2025

News Article

 Incyte to Unveil New Data from its Dermatology Portfolio at 2025 American Academy of Dermatology (AAD) Annual Meeting

12/06/2023

PubMed

 Novel Pharmacological Treatment Options of Steroid-Refractory Graft-versus-Host Disease.

04/01/2023

PubMed

 Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study.

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