Drugs / Axatilimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic graft versus host disease | — | “FDA had accepted the Biologics License Application (BLA) filing for axatilimab” syndax.com ↗ |
Trials 23
| 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 | breast cancer | M.D. Anderson Cancer Center | Suspended | No outcome recorded |
| Phase 1 | NCT06713590 | Jan → Jun 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06488378 | Aug 2024 → May 2027 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 1/24 trials · 1 met primary | ||||||
| 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 | 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 | Met primary |
| Phase 212 trials · 1 met primary | ||||||
| Phase 2 | NCT07808112 | Nov 2026 → Nov 2031 expected | graft versus host disease | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07349771 | Jun 2026 → Jun 2028 | hematopoietic and lymphoid system neoplasm | Mayo Clinic | Withdrawn | No outcome recorded Stop: Business |
| 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 overdue | 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 | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05544032 | — | chronic graft versus host disease | Incyte Corporation | Approved for marketing | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04415073 Comparator | May → Jul 2020 | COVID-19, acute respiratory distress syndrome, cytokine release syndrome | Syndax Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2025-01-15 | Syndax Pharmaceuticals | Regulatory Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes syndax.com ↗
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. |
| 2025-01-15 | Incyte Corporation | Regulatory 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 ↗
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. |
| 2024-11-05 | Syndax Pharmaceuticals | Results Syndax Announces New Data from Secondary Analysis of the Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease to Be Presented at 66th ASH Annual Meeting syndax.com ↗
Rapid responses and symptom improvement observed in inflammatory and fibrotic manifestations of chronic GVHD in heavily pretreated patients |
| 2024-09-18 | Syndax Pharmaceuticals | Results 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 syndax.com ↗
The results show that the trial met the primary endpoint across all cohorts receiving Niktimvo at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks. |
| 2024-09-18 | Incyte Corporation | Results 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 ↗
The results show that the trial met the primary endpoint across all cohorts receiving Niktimvo at doses of 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks and 3.0 mg/kg every four weeks. |
| 2024-08-14 | Syndax Pharmaceuticals | Regulatory Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD) syndax.com ↗
Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD |
| 2024-08-14 | Incyte Corporation | Regulatory Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD) incyte.com ↗
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.). |
| 2024-02-27 | Incyte Corporation | Regulatory Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease incyte.com ↗
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. |
| 2023-12-10 | Syndax Pharmaceuticals | Results 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 syndax.com ↗
Patients who received axatilimab at 0.3 mg/kg every two weeks achieved the highest overall response rate (ORR) of 74% within the first six months of treatment (95% CI; 63-83). |
| 2023-12-10 | Incyte Corporation | Results 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 ↗
Patients who received axatilimab at 0.3 mg/kg every two weeks achieved the highest overall response rate (ORR) of 74% within the first six months of treatment (95% CI; 63-83). |
| 2023-07-24 | Syndax Pharmaceuticals | Results Syndax and Incyte Announce Positive Topline Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease syndax.com ↗
Trial met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks |
| 2023-07-24 | Incyte Corporation | Results Syndax and Incyte Announce Positive Topline Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease incyte.com ↗
Trial met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks |
| 2022-12-05 | Syndax Pharmaceuticals | Results 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 syndax.com ↗
Results showed: Overall response rate by cycle 7 day 1 was 82% (18/22) in the Phase 2 cohort (1mg/kg every two weeks) and 67% (26/39) among all evaluable patients treated in the dose escalation study. |
| 2022-12-05 | Incyte Corporation | Results 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 ↗
Overall response rate by cycle 7 day 1 was 82% (18/22) in the Phase 2 cohort (1mg/kg every two weeks) and 67% (26/39) among all evaluable patients treated in the dose escalation study. |
| 2021-12-11 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Updated Positive Data Demonstrating Broad Activity and Tolerability of Axatilimab in Patients with Chronic Graft-Versus-Host Disease syndax.com ↗ |
| 2021-11-04 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals to Present Updated Data from SNDX-5613 and Axatilimab Clinical Programs During Oral Sessions at 63rd ASH Annual Meeting syndax.com ↗
With additional patients and longer follow up, we have observed a high rate of durable responses and multiorgan clinical benefit in patients refractory to multiple therapeutic agents. |
| 2021-04-08 | Syndax Pharmaceuticals | Regulatory Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Idiopathic Pulmonary Fibrosis syndax.com ↗
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). |
| 2021-03-31 | Syndax Pharmaceuticals | Regulatory Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Chronic Graft Versus Host Disease syndax.com ↗
"Receipt of Orphan Drug Designation underscores axatilimab's potential to serve as a safe and effective intervention for patients with cGVHD," said Briggs W. Morrison , M.D., Chief Executive Officer of Syndax. |
| 2020-12-06 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Additional Positive Data from Phase 1 Trial of Axatilimab in Patients with cGVHD syndax.com ↗
Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated data from the Company's Phase 1 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). |
| 2020-11-04 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals to Present Updated Data from Phase 1 Trial of Axatilimab in cGVHD During Oral Session at the 62nd ASH Annual Meeting syndax.com ↗ |
| 2020-04-27 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias syndax.com ↗
These data indicate that axatilimab is tolerated well in solid tumor patients, generated a recommended Phase 2 dose for axatilimab for the treatment of patients with solid tumors, and provided evidence of its ability to deplete circulating pro-inflammatory monocytes. |
| 2019-12-10 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Plans to Commence Phase 2 Expansion Cohort of SNDX-6352 for the Treatment of Chronic Graft Versus Host Disease syndax.com ↗
Responses have been observed in all evaluable patients as of the data cutoff date, with no dose limiting toxicities (DLTs) reported. |
| 2019-11-07 | Syndax Pharmaceuticals | Regulatory Syndax Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Business Update syndax.com ↗
Syndax today announced that the FDA has agreed to a recent request to amend enrollment criteria for its ongoing Phase 1 dose escalation trial of SNDX-6352, the Company's anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). |
| 2017-11-11 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Announces Presentation of Data from Immuno-oncology Clinical Trials at the Society for Immunotherapy of Cancer 32nd Annual Scientific Meeting syndax.com ↗ |
All press releases naming this drug 34 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 25 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 ↗22“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 ↗ |