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Itacitinib

Phase 2Small molecule

Itacitinib is an experimental drug being studied to treat blood cancers and certain immune system disorders by blocking proteins that help cancer cells or abnormal immune cells grow.[1] Itacitinib is currently being investigated across 3 indications[3], with its most advanced program in Phase 2.[1]

Itacitinib is one of 35 small molecule programs targeting Systemic Sclerosis. It is currently in Phase 2.

3

Indications

47

Total Trials

7

Active Trials

34

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic SclerosisRecruiting

Classical Hodgkin LymphomaActive, not recruiting

Leukemia, AcuteActive, not recruiting

Systemic SclerosisPhase 2

Recruiting

Classical Hodgkin LymphomaPreclinical

Active, not recruiting

Leukemia, AcutePhase 1

Active, not recruiting

Competition

Competitive Landscape

39 competitors in Systemic Sclerosis

#DrugCompanyPhaseTrials

Tracleer

Johnson & Johnson

Olumiant

Flagyl

DDePuy Orthopaedics

IC-Green

PProvepharm SAS

Rituxan

Cytoxan

BBaxter Healthcare Corporation

Mesnex

BBaxter Healthcare Corporation

UPLIZNA

HHorizon Therapeutics Ireland DAC

Cellcept

Rezzayo

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Diffuse Large B-Cell Lymphoma

NCT05757219

Phase 2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05364762

Q2 2027

Phase 2Active, not recruiting

Hematologic and Lymphocytic Disorder

NCT04859946

PreclinicalActive, not recruiting

Classical Hodgkin Lymphoma

NCT03697408

Q4 2027

PreclinicalRecruiting

MDS/MPN

NCT04061421

Q1 2030

Phase 1Active, not recruiting

Leukemia, Acute

NCT05823571

Clinical

Trials by Indication[1]

Acute Graft Versus Host Disease4 trials

A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Terminated· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1/2·NCT04220632·1 enrolled

Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

Completed· Incyte logo

Incyte·Phase 1·NCT03497273·14 enrolled

GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

Completed· Incyte logo

Incyte·Phase 3·NCT03139604·439 enrolled

Show 1 more trial

Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

Terminated·—·Phase 1·NCT04070781·1 enrolled

Myelofibrosis4 trials

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)

Completed· Incyte logo

Incyte·Phase 2·NCT04629508·4 enrolled

A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis

Completed· Incyte logo

Incyte·Phase 2·NCT03144687·23 enrolled

An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis

Completed· Incyte logo

Incyte·Phase 2·NCT01633372·87 enrolled

Show 1 more trial

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)

Terminated· Incyte logo

Incyte·Phase 2·NCT04640025·18 enrolled

Advanced Solid Tumors3 trials

Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors

Completed· Incyte logo

Incyte·Phase 1·NCT02646748·159 enrolled

Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Completed· Incyte logo

Incyte·Phase 1/2·NCT01858883·55 enrolled

Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1·NCT02559492·142 enrolled

Non-Small Cell Lung Cancer3 trials

An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

Completed· Incyte logo

Incyte·Phase 1/2·NCT02917993·59 enrolled

Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer

Terminated·UUniversity of Pennsylvania·Phase 2·NCT03425006·23 enrolled

Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

Terminated· Incyte logo

Incyte·Phase 2·NCT02257619·9 enrolled

Bronchiolitis Obliterans2 trials

Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT04239989·8 enrolled

Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation

Terminated· Incyte logo

Incyte·Phase 1/2·NCT03978637·23 enrolled

28 more indications

Graft Versus Host Disease2 trials

Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04127721

Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects

Terminated· Incyte logo

Incyte·Phase 1/2·NCT03721965·2 enrolled

Chronic Graft Versus Host Disease2 trials

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Terminated· Incyte logo

Incyte·Phase 2/3·NCT03584516·155 enrolled

A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT04200365·15 enrolled

Diffuse Large B-Cell Lymphoma2 trials

A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Completed· Incyte logo

Incyte·Phase 1/2·NCT02760485·33 enrolled

A Phase 2, Single-Arm, Open-Label Study Using Itacitinib as Pre-Modulation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Receiving CAR-T-Cell Therapy

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05757219·27 enrolled

Hepatocellular Carcinoma1 trial

Itacitinib in Advanced Hepatocellular Carcinoma

Unknown status·IImperial College London·Phase 1·NCT04358185·24 enrolled

Lymphoma1 trial

INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma

Terminated· Incyte logo

Incyte·Phase 2·NCT02456675·8 enrolled

Ulcerative Colitis1 trial

A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Withdrawn· Incyte logo

Incyte·Phase 2·NCT03627052

Systemic Sclerosis1 trial

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04789850·74 enrolled

Psoriasis1 trial

A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis

Completed· Incyte logo

Incyte·Phase 2·NCT01634087·50 enrolled

Hematopoietic Cell Transplantation1 trial

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Completed·WWashington University School of Medicine·Phase 1·NCT03755414·55 enrolled

Rheumatoid Arthritis1 trial

A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis

Completed· Incyte logo

Incyte·Phase 2·NCT01626573·106 enrolled

Low Risk1 trial

Itacitinib for Low Risk GVHD

Completed·JJohn Levine·Phase 2·NCT03846479·70 enrolled

Cytokine Release Syndrome1 trial

A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Completed· Incyte logo

Incyte·Phase 2·NCT04071366·112 enrolled

Refractory Metastatic1 trial

Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas

Terminated·FFred Hutchinson Cancer Center·Phase 1·NCT03670069·27 enrolled

Small Cell Lung Cancer1 trial

Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Withdrawn· Incyte logo

Incyte·Phase 2·NCT02355431

First-line Treatment1 trial

Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD

Terminated·UUniversity of Utah·Phase 2·NCT04446182·3 enrolled

Immune Checkpoint Inhibitors1 trial

Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Withdrawn·DDouglas Johnson·Phase 2·NCT05660421

T-Cell Prolymphocytic Leukemia1 trial

Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03989466·15 enrolled

Prophylaxis1 trial

GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

Terminated· Incyte logo

Incyte·Phase 1·NCT03320642·84 enrolled

B-cell Malignancies1 trial

A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

Completed· Incyte logo

Incyte·Phase 1/2·NCT02018861·88 enrolled

Corticosteroids1 trial

Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

Completed· Incyte logo

Incyte·Phase 1·NCT02614612·31 enrolled

Histiocytosis1 trial

Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05063110·35 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Function1 trial

Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease

Available· Incyte logo

Incyte··NCT05561985

MDS/MPN1 trial

The ABNL-MARRO 001 Study: A Phase 1/2 Study of Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes.

Recruiting·MMichael Savona·Preclinical·NCT04061421·94 enrolled

Acute Lymphoblastic Leukemia1 trial

Single Center Pilot Study to Investigate the Efficacy of Adding Itacitinib to Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning Matched Donor Hematopoietic Cell Transplantation With Peripheral Blood Stem Cells as Graft Source

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT05364762·20 enrolled

Hematologic and Lymphocytic Disorder1 trial

Itacitinib to Prevent Graft Versus Host Disease

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04859946·31 enrolled

Leukemia, Acute1 trial

Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression Following Nonmyeloablative Related Partially HLA-mismatched Peripheral Blood Stem Cell Transplant (PBSCT) With High-dose Posttransplantation Cyclophosphamide in Older Patients (Age 60 Years)

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT05823571·32 enrolled

Classical Hodgkin Lymphoma1 trial

An Open-Label Phase I/II Safety and Efficacy Study of Itacitinib In Combination With Everolimus In Subjects With Relapsed/Refractory Classical Hodgkin Lymphoma

Active, not recruiting·UUniversity of Pennsylvania·Preclinical·NCT03697408·23 enrolled

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for Itacitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Itacitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Itacitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase JAK1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Incyte

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