Axatilimab
Trade name: Niktimvo
mAbapprovedOrphan Drug FDAFast Track FDA
Approved
Aug 14, 2024
Clinical trial activity
23 trials · 16 clinical orgs · 1 marketing orgs
Phase 1
9
Phase 2
18
Phase 3
3
Phase 4
0
Earliest trial started Sep 1, 2017 (NCT03238027)
Timeline
Indications
Approved for
Studied for
- BRCA1 Protein · Phase 1
- Breast Neoplasms · Phase 2
- Cholangiocarcinoma · Phase 2
- Coronavirus · Phase 2
- COVID-19 · Phase 2
- Cytokine Release Syndrome · Phase 2
- Graft vs Host Disease · Phase 3
- Healthy Volunteers · Phase 1
- Hodgkin Disease · Phase 2
- Idiopathic Pulmonary Fibrosis · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1/Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 1/Phase 2
- Mutation · Phase 1
- Myeloproliferative Disorders · Phase 1/Phase 2
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 1/Phase 2
- Primary Myelofibrosis · Phase 1/Phase 2
- Severe Acute Respiratory Syndrome · Phase 2
Mechanism of action
Macrophage colony stimulating factor receptor inhibitor
Approval history
- approvedPriority reviewFast trackAug 14, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL4594608 ↗
Also known as
- sndx-6352
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07128381 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2026 | University of Texas at Houston |
| NCT07124078 | Phase 2 | Dec 15, 2025 | Incyte |
| NCT07015853 | Phase 2 | Sep 30, 2025 | Cedars-Sinai Medical Center, Incyte, Merck |
| NCT06959537 | Phase 1 | Aug 13, 2025 | University of Texas at Houston |
| NCT07011810 | Phase 2 | Jul 31, 2025 | Incyte, University of Washington |
| NCT06821542 | Phase 3 | Jun 30, 2025 | Incyte |
| NCT06843408 | Phase 1/Phase 2 (Phase 2) | May 15, 2025 | Incyte |
| NCT06585774 | Phase 3 | Jan 31, 2025 | Incyte |
| NCT06713590 | Phase 1 | Jan 14, 2025 | Incyte |
| NCT06663722 | Phase 2 | Dec 30, 2024 | Incyte, University of Miami |
| NCT06388564 | Phase 2 | Oct 11, 2024 | Incyte |
| NCT06488378 | Phase 1 | Aug 13, 2024 | Harvard University, Incyte |
| NCT06523556 | Phase 1/Phase 2 (Phase 2) | Aug 2, 2024 | Incyte, Ohio State University |
| NCT06263478 | Phase 3 | Jul 30, 2024 | Incyte |
| NCT06320405 | Phase 1/Phase 2 (Phase 2) | May 31, 2024 | Incyte, OHSU Knight Cancer Institute, Oregon Health and Science University |
| NCT06132256 | Phase 2 | Nov 30, 2023 | DevPro Biopharma, Syndax Pharmaceuticals |
| NCT05723055 | Phase 2 | Apr 18, 2023 | Incyte, University of Utah |
| NCT05491226 | Phase 2 | Dec 1, 2022 | Cedars-Sinai Medical Center, Incyte, Merck |
| NCT04710576 | Phase 2 | Mar 4, 2021 | Syndax Pharmaceuticals |
| NCT04301778 | Phase 2 | May 31, 2020 | AstraZeneca, Johns Hopkins University, Syndax Pharmaceuticals |
Showing 20 of 23 trials
Page 1 / 2
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Incyte | For profit | 15 | 7 | 3 | 2022 |
| Syndax Pharmaceuticals | For profit | 6 | 5 | 2 | 2017 |
| Cedars-Sinai Medical Center | Academic/Hospital | 2 | 2 | 1 | 2022 |
| Merck | For profit | 2 | 0 | 1 | 2022 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 2 | 2025 |
| AstraZeneca | For profit | 1 | 0 | 1 | 2020 |
| DevPro Biopharma | For profit | 1 | 0 | 1 | 2023 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| HonorHealth Research Institute | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| OHSU Knight Cancer Institute | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Oregon Health and Science University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Miami | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Utah | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of Washington | Academic/Hospital | 1 | 1 | 1 | 2025 |
16 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Incyte | For profit | NDA | Aug 14, 2024 |