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Drug

Itacitinib

Approved medicine
ClassTyrosine-protein kinase JAK1 inhibitorResearchOngoing clinical research
RxNorm1939995ChEMBLCHEMBL3622820ATCL04AF05UNII19J3781LPM
7
Active clinical trials
Tyrosine-protein kinase JAK1
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-06-23Results posted · ClinicalTrials.gov

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

Clinical trial2026-06-20Primary completion · ClinicalTrials.gov

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

Clinical trial2026-06-03Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-05-11Terminated · ClinicalTrials.gov

A Phase Ib Study of Itacitinib, a JAK1 Inhibitor, in Advanced Hepatocellular Carcinoma

Clinical trial2026-05-04Results posted · ClinicalTrials.gov

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

Clinical trial2026-04-21Results expected Q3 2027 · ClinicalTrials.gov

Itacitinib to Prevent Graft Versus Host Disease

Clinical trial2026-04-16Results expected Q2 2027 · ClinicalTrials.gov

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

Clinical trial2026-02-28Primary completion · ClinicalTrials.gov

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

Clinical trial2025-12-24Completed · ClinicalTrials.gov

A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)

Clinical trial2025-10-31Terminated · ClinicalTrials.gov

Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB a Phase II Prospective Trial

Clinical trial2025-10-01Completed · ClinicalTrials.gov

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)

Clinical trial2025-09-18Results expected Q1 2028 · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Itacitinib
RxNorm CUI
1939995
ChEMBL ID
CHEMBL3622820
ATC codes
L04AF05
UNII
19J3781LPM
Primary mechanism
Tyrosine-protein kinase JAK1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tyrosine-protein kinase JAK1
JAK1 · P23458
INHIBITORTyrosine-protein kinase JAK1 inhibitor

Clinical trials

46 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
46
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
3
Recruiting
2
Late-stage (III+)
19
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 46
Phase 112Phase 1 / 29Phase 223Phase 2 / 31Phase 31

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH I/IIIncyte Corporationn=592025

Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB a Phase II Prospective Trial

CompletedPH IIAssistance Publique - Hôpitaux de Parisn=352025

Phase Ib Pilot Study of Itacitinib With Alemtuzumab in Patients With T-Cell Prolymphocytic Leukemia (T-PLL)

CompletedPH IM.D. Anderson Cancer Centern=152024

A Single-Arm, Open-Label, Pilot Study and Expansion Study of JAK Inhibitor Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

CompletedPH IWashington University School of Medicinen=552024

A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy

CompletedPH IIIncyte Corporationn=42023

A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

CompletedPH IIIncyte Corporationn=1122023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials