Drugs / Axatilimab
Trials 26 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07638982 | Oct 2026 → Dec 2028 expected | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Northside Hospital, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07511062 | Aug 2026 → Aug 2029 expected | acute myeloid leukemia | Northside Hospital, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06959537 | Aug 2025 → Jan 2027 expected | breast cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06713590 | Jan → Jun 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06488378 | Aug 2024 → Sep 2026 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, Her2-receptor negative breast cancer, PALB2-related cancer predisposition | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT03238027 | Sep 2017 → Nov 2020 | cancer, metastatic neoplasm | Syndax Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07128381 | Jan 2026 → Jul 2031 expected | chronic myelomonocytic leukemia, myelofibrosis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06843408 | Jun 2025 → Jul 2026 overdue | chronic graft versus host disease | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06523556 | Aug 2024 → Oct 2027 expected | atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia | Uma Borate | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06320405 | May 2024 → Apr 2027 expected | cancer | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03604692 | Nov 2018 → Aug 2022 | chronic graft versus host disease | Syndax Pharmaceuticals | Completed | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07349771 | Jun 2026 → Jun 2028 expected | hematopoietic and lymphoid system neoplasm | Mayo Clinic | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07015853 | Jun 2026 → Jul 2033 expected | triple-negative breast carcinoma | Stephen Shiao | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07124078 | May 2026 → Jan 2029 expected | chronic graft versus host disease | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT07011810 | Aug 2025 → Aug 2028 expected | chronic graft versus host disease | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06663722 | May 2025 → May 2030 expected | chronic graft versus host disease | University of Miami | Recruiting | No outcome recorded |
| Phase 2 | NCT06388564 | Oct 2024 → Jun 2027 expected | chronic graft versus host disease | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06132256 | Dec 2023 → Sep 2026 expected | idiopathic pulmonary fibrosis | Syndax Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05491226 | Nov 2023 → Dec 2026 expected | triple-negative breast carcinoma | Stephen Shiao | Recruiting | No outcome recorded |
| Phase 2 | NCT05723055 | May 2023 → Dec 2026 expected | Hodgkins lymphoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04301778 | Aug 2021 → Nov 2022 | intrahepatic cholangiocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT04710576 | Mar 2021 → Apr 2023 overdue | chronic graft versus host disease | Syndax Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06821542 | Jun 2025 → May 2028 expected | chronic graft versus host disease | Incyte Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06585774 | Jan 2025 → Sep 2027 expected | chronic graft versus host disease | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06263478 | Jul 2024 → Aug 2025 overdue | chronic graft versus host disease | Incyte Biosciences Japan GK | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05544032 | — | chronic graft versus host disease | Incyte Corporation | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04415073 Comparator | May → Jul 2020 | COVID-19, acute respiratory distress syndrome, cytokine release syndrome | Syndax Pharmaceuticals | Terminated | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-15 | Incyte Corporation | Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes incyte.com ↗ |
| 2024-09-18 | Incyte Corporation | Incyte and Syndax Announce New England Journal of Medicine Publication of Data from Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2024-08-14 | Incyte Corporation | Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD) incyte.com ↗ |
| 2024-02-27 | Incyte Corporation | Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2023-12-10 | Incyte Corporation | Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2023-07-24 | Incyte Corporation | Syndax and Incyte Announce Positive Topline Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease incyte.com ↗ |
| 2022-12-05 | Incyte Corporation | Syndax Pharmaceuticals and Incyte Announce Axatilimab Phase 1/2 Data in Patients with Chronic Graft-Versus-Host Disease Published in the Journal of Clinical Oncology incyte.com ↗ |
| 2021-09-27 | Incyte Corporation | Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases incyte.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Axatilimab | “Axatilimab (SNDX-6352) is a humanized immunoglobin G4 monoclonal antibody with high affinity against colony stimulating factor-1 receptor (CSF-1R) under investigation for the...” NCT04415073 ↗21“Axatilimab at the protocol-defined dose.” NCT07124078 ↗ |
| Known as | Axatilimab-csfr | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594608 ↗ |
| Known as | INCA034176 | “Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.” NCT07015853 ↗ |
| Known as | Niktimvo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594608 ↗ |
| Known as | SNDX 6532 | “Nivolumab 480 mg IV Q4 weeks Axatilimab (SNDX 6532) dose (3mg/kg IV) Q4 weeks.” NCT05723055 ↗ |
| Known as | SNDX-6352 | “Axatilimab (SNDX-6352) is a humanized IgG4 monoclonal antibody (mAb) with high affinity against colony stimulating factor-1 receptor (CSF-1R).” NCT05723055 ↗5“Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance.” NCT07015853 ↗ “Drug: Axatilimab (SNDX-6352)” NCT06959537 ↗ “Axatilimab (SNDX-6352)” NCT07128381 ↗ |
| Known as | UCB-6352 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594608 ↗ |
| Action | Inhibit | “blocks colony stimulating factor 1 receptor (CSF-1R)” NCT03238027 ↗ |
| Modality | Monoclonal antibody | “Humanized IgG4 mAb” NCT03238027 ↗ |
| Route | Intravenous | “Intravenous (IV) infusion” NCT03604692 ↗ |
| Target | CSF1R | “blocks colony stimulating factor 1 receptor (CSF-1R)” NCT03238027 ↗ |