Numerous clinical trials, spanning Phase 1 through Phase 3, have evaluated itacitinib across indications including acute graft-versus-host disease, bronchiolitis obliterans syndrome, non-severe hemophagocytic lymphohistiocytosis, myelofibrosis, plaque psoriasis, and solid tumors. Sponsored by pharmaceutical entities such as Incyte Corporation and academic centers like M.D. Anderson Cancer Center, trial statuses range from active recruitment to completion or termination. For instance, a clinical trial is currently recruiting patients with non-severe hemophagocytic lymphohistiocytosis, whereas a clinical trial evaluating plaque psoriasis has been completed.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05823571 | ACTIVE_NOT_RECRUITING | Leukemia, Acute; Myelodysplastic Syndromes; Myelomonocytic Leukemia, Chronic; T-cell Prolymphocytic Leukemia; CML; Myeloproliferative Disorders; Multiple Myeloma; Plasma Cell Leukemia |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2023-07-06 | PHASE1 |
| NCT04061421 | RECRUITING | MDS/MPN |
Michael Savona |
2021-11-24 | PHASE1; PHASE2 |
| NCT04859946 | ACTIVE_NOT_RECRUITING | Hematologic and Lymphocytic Disorder |
M.D. Anderson Cancer Center |
2022-01-11 | PHASE2 |
| NCT05364762 | ACTIVE_NOT_RECRUITING | Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Primary Myelofibrosis; Secondary Myelofibrosis |
City of Hope Medical Center |
2022-11-23 | PHASE2 |
| NCT04509700 | ACTIVE_NOT_RECRUITING | B-Cell Malignancies |
Incyte Corporation |
2020-08-03 | PHASE2 |
| NCT05757219 | RECRUITING | Diffuse Large B Cell Lymphoma |
H. Lee Moffitt Cancer Center and Research Institute |
2023-05-19 | PHASE2 |
| NCT04640025 | TERMINATED | Myelofibrosis; Postlung Transplant (Bronchiolitis Obliterans); Chronic Graft Versus Host Disease |
Incyte Corporation |
2021-03-10 | PHASE2 |
| NCT01905813 | COMPLETED | B-cell Malignancies |
Incyte Corporation |
2013-06-30 | PHASE1 |
| NCT04789850 | RECRUITING | Systemic Sclerosis |
Assistance Publique - Hôpitaux de Paris |
2023-02-02 | PHASE2 |
| NCT02917993 | COMPLETED | Lung Cancer |
Incyte Corporation |
2016-12-20 | PHASE1; PHASE2 |
| NCT04239989 | TERMINATED | Bronchiolitis Obliterans |
M.D. Anderson Cancer Center |
2021-10-08 | PHASE1 |
| NCT05063110 | COMPLETED | Adults Patients Having Non Severe HLH |
Assistance Publique - Hôpitaux de Paris |
2022-05-03 | PHASE2 |
| NCT05660421 | WITHDRAWN | Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm |
Douglas Johnson |
2023-03-03 | PHASE2 |
| NCT04591431 | UNKNOWN | Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer |
Fondazione per la Medicina Personalizzata |
2020-10-07 | PHASE2 |
| NCT03989466 | COMPLETED | Recurrent T-Cell Prolymphocytic Leukemia; T-Cell Prolymphocytic Leukemia |
M.D. Anderson Cancer Center |
2020-01-15 | PHASE1 |
| NCT03697408 | ACTIVE_NOT_RECRUITING | Classical Hodgkin Lymphoma |
University of Pennsylvania |
2019-02-11 | PHASE1; PHASE2 |
| NCT03755414 | COMPLETED | Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndromes; Non-Hodgkin Lymphoma; Hodgkin Disease |
Washington University School of Medicine |
2019-09-04 | PHASE1 |
| NCT03584516 | TERMINATED | Chronic Graft-versus-host Disease |
Incyte Corporation |
2019-01-17 | PHASE2; PHASE3 |
| NCT03978637 | TERMINATED | Bronchiolitis Obliterans Syndrome |
Incyte Corporation |
2020-02-04 | PHASE1; PHASE2 |
| NCT04200365 | TERMINATED | Chronic Graft-versus-host-disease |
SCRI Development Innovations, LLC |
2020-06-05 | PHASE2 |
| NCT04629508 | COMPLETED | Myelofibrosis; Polycythemia Vera; Thrombocythemia |
Incyte Corporation |
2021-07-12 | PHASE2 |
| NCT04339101 | COMPLETED | Acute Leukemia; Hematologic and Lymphocytic Disorder; Myelodysplastic Syndrome; Primary Myelofibrosis; Secondary Myelofibrosis |
City of Hope Medical Center |
2020-11-11 | PHASE2 |
| NCT04358185 | COMPLETED | Advanced Hepatocellular Carcinoma |
Imperial College London |
2018-12-03 | PHASE1 |
| NCT03670069 | TERMINATED | Metastatic Leiomyosarcoma; Metastatic Synovial Sarcoma; Metastatic Undifferentiated Pleomorphic Sarcoma; Advanced Myxoid Liposarcoma; Advanced Soft Tissue Sarcoma; Metastatic Myxoid Liposarcoma; Metastatic Round Cell Liposarcoma; Metastatic Soft Tissue Sarcoma; Refractory Leiomyosarcoma; Refractory Myxoid Liposarcoma; Refractory Round Cell Liposarcoma; Refractory Soft Tissue Sarcoma; Refractory Synovial Sarcoma; Refractory Undifferentiated Pleomorphic Sarcoma; Advanced Leiomyosarcoma; Advanced Synovial Sarcoma; Advanced Undifferentiated Pleomorphic Sarcoma; Metastatic Chondrosarcoma |
Fred Hutchinson Cancer Center |
2019-09-30 | PHASE1 |
| NCT04071366 | COMPLETED | Cytokine Release Syndrome |
Incyte Corporation |
2020-02-07 | PHASE2 |
| NCT02760485 | COMPLETED | Lymphoma |
Incyte Corporation |
2016-12-29 | PHASE1; PHASE2 |
| NCT05063110 | Recruiting | Adults Patients Having Non Severe HLH |
Assistance Publique - Hôpitaux de Paris|Incyte Corporation |
2022-05-01 | Phase 2 |
| NCT04446182 | TERMINATED | Chronic Graft-versus-host-disease |
University of Utah |
2021-01-29 | PHASE2 |
| NCT04070781 | TERMINATED | Steroid Refractory GVHD; Graft Vs Host Disease |
Columbia University |
2020-01-20 | PHASE1 |
| NCT03425006 | TERMINATED | Non Small Cell Lung Cancer |
University of Pennsylvania |
2018-06-18 | PHASE2 |
| NCT03846479 | COMPLETED | Low Risk Acute Graft-versus-host Disease; Graft-versus-host-disease; GVHD |
John Levine |
2019-03-25 | PHASE2 |
| NCT02018861 | COMPLETED | B-Cell Malignancies |
Incyte Corporation |
2016-09-22 | PHASE1; PHASE2 |
| NCT04239989 | Active not recruiting | Bronchiolitis Obliterans |
M.D. Anderson Cancer Center |
2021-04-08 | Phase 1 |
| NCT03320642 | TERMINATED | Hematologic Malignancies |
Incyte Corporation |
2018-02-27 | PHASE1 |
| NCT04220632 | TERMINATED | GVHD,Acute |
Innovent Biologics (Suzhou) Co. Ltd. |
2020-06-18 | PHASE1; PHASE2 |
| NCT04127721 | WITHDRAWN | Allogeneic Stem Cell Transplant Recipient; Hematologic and Lymphocytic Disorder; Hematopoietic and Lymphoid Cell Neoplasm |
M.D. Anderson Cancer Center |
2020-09-22 | PHASE2 |
| NCT04220632 | Terminated | GVHDAcute |
Innovent Biologics (Suzhou) Co. Ltd. |
2020-06-18 | Phase 1|Phase 2 |
| NCT03144687 | COMPLETED | MPN (Myeloproliferative Neoplasms) |
Incyte Corporation |
2018-01-26 | PHASE2 |
| NCT03721965 | TERMINATED | Acute Graft-versus-host Disease |
Incyte Corporation |
2019-12-31 | PHASE1; PHASE2 |
| NCT03978637 | Terminated | Bronchiolitis Obliterans Syndrome |
Incyte Corporation |
2020-02-04 | Phase 1|Phase 2 |
| NCT04070781 | Terminated | Steroid Refractory GVHD|Graft Vs Host Disease |
Columbia University|Incyte Corporation |
2020-01-20 | Phase 1 |
| NCT03721965 | Terminated | Acute Graft-versus-host Disease |
Incyte Corporation |
2019-12-31 | Phase 1|Phase 2 |
| NCT03497273 | COMPLETED | Acute Graft-versus-host Disease |
Incyte Corporation |
2018-03-20 | PHASE1 |
| NCT03627052 | WITHDRAWN | Moderate to Severe Ulcerative Colitis |
Incyte Corporation |
2018-09-20 | PHASE2 |
| NCT02646748 | COMPLETED | Colorectal Cancer (CRC); Endometrial Cancer; Melanoma; Head and Neck Cancer; Lung Cancer; MMR-deficient Tumors; Breast Cancer; Pancreatic Cancer; Renal Cell Carcinoma (RCC); Solid Tumors; UC (Urothelial Cancer) |
Incyte Corporation |
2016-01-25 | PHASE1 |
| NCT03139604 | COMPLETED | Graft-versus-host Disease (GVHD) |
Incyte Corporation |
2017-07-19 | PHASE3 |
| NCT02559492 | TERMINATED | Solid Tumors |
Incyte Corporation |
2015-11 | PHASE1 |
| NCT02456675 | TERMINATED | Refractory Hodgkin Lymphoma; Recurrent Adult Hodgkin's Lymphoma |
Incyte Corporation |
2015-06 | PHASE2 |
| NCT02614612 | COMPLETED | Graft-versus-host Disease (GVHD) |
Incyte Corporation |
2015-12 | PHASE1 |
| NCT01858883 | COMPLETED | Solid Tumors; Pancreatic Cancer |
Incyte Corporation |
2013-06 | PHASE1; PHASE2 |
| NCT02257619 | TERMINATED | NSCLC (Non-small Cell Lung Carcinoma) |
Incyte Corporation |
2014-09-24 | PHASE2 |
| NCT02355431 | WITHDRAWN | Solid Tumors and Hematologic Malignancy; NSCLC (Non-small Cell Lung Carcinoma) |
Incyte Corporation |
2014-12 | PHASE2 |
| NCT01633372 | COMPLETED | MPN (Myeloproliferative Neoplasms) |
Incyte Corporation |
2012-07-16 | PHASE2 |
| NCT01626573 | COMPLETED | Rheumatoid Arthritis |
Incyte Corporation |
2012-03 | PHASE2 |
| NCT01634087 | COMPLETED | Plaque Psoriasis |
Incyte Corporation |
2012-06 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-09-18)
Check the
Itacitinib (INCB39110)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Itacitinib (INCB39110) Solubility in DMSO
- Itacitinib (INCB39110) Stock Solution
- Itacitinib (INCB39110) Storage
- Itacitinib (INCB39110) Stability
- Itacitinib (INCB39110) Molecular Weight
- Itacitinib (INCB39110) SMILES
- Itacitinib (INCB39110) CAS Number
- Itacitinib (INCB39110) Chemical Structure (2D and 3D)
- Itacitinib (INCB39110) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.