Drugs / Itacitinib
last change Jun 2026 re-read 2 minutes ago

Itacitinib

Small molecule targets IL6, JAK1 via inhibition

Developed for
acute graft versus host disease · chronic graft versus host disease · myelofibrosis · non-small cell lung carcinoma · B-cell neoplasm · breast cancer · bronchiolitis obliterans syndrome · cancer
+33 more · Hodgkins lymphoma · lung cancer · malignant pancreatic neoplasm · melanoma · myeloproliferative neoplasm · T-cell prolymphocytic leukemia · aplastic anemia · chondrosarcoma · classic Hodgkin lymphoma · colorectal cancer · cytokine release syndrome · diffuse large B-cell lymphoma · digestive system cancer · endometrial cancer · graft versus host disease · head and neck cancer · hematologic disorder · hemophagocytic syndrome · hepatocellular carcinoma · large B-cell lymphoma · leiomyosarcoma · myelodysplastic/myeloproliferative neoplasm · myxoid liposarcoma · psoriasis · renal cell carcinoma · rheumatoid arthritis · round cell liposarcoma · synovial sarcoma · systemic sclerosis · transplant-related bronchiolitis obliterans · ulcerative colitis · undifferentiated pleomorphic sarcoma · urothelial carcinoma
Investigated by
Incyte Corporation · M.D. Anderson Cancer Center · National Cancer Institute (NCI) · Assistance Publique - Hôpitaux de Paris · City of Hope Medical Center · University of Pennsylvania
+20 more · Washington University School of Medicine · American Society of Hematology · Astex Pharmaceuticals, Inc. · AstraZeneca · Columbia University · Douglas Johnson · Fondazione per la Medicina Personalizzata · Fred Hutchinson Cancer Center · H. Lee Moffitt Cancer Center and Research Institute · Imperial College London · Incyte Biosciences UK · Innovent Biologics (Suzhou) Co. Ltd. · John Levine · Massachusetts General Hospital · Michael Savona · SCRI Development Innovations, LLC · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Theradex · URC-CIC Paris Descartes Necker Cochin · University of Utah

Trials 53 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 114 trials
Phase 1 NCT05823571 Jul 2023 → Mar 2028 expected T-cell prolymphocytic leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome +2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Active not recruiting No outcome recorded
Phase 1 NCT04239989 Oct 2021 → Oct 2025 bronchiolitis obliterans syndrome M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 1 NCT04070781 Jan 2020 → Dec 2021 graft versus host disease Columbia University Terminated No outcome recorded
Phase 1 NCT03989466 Jan 2020 → Sep 2024 T-cell prolymphocytic leukemia M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT03670069 Sep 2019 → Mar 2023 chondrosarcoma, leiomyosarcoma, myxoid liposarcoma, round cell liposarcoma +2 Fred Hutchinson Cancer Center Terminated No outcome recorded
Phase 1 NCT03755414 Sep 2019 → Apr 2024 Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome Washington University School of Medicine Completed No outcome recorded
Phase 1 NCT03272464 May → Jul 2019 melanoma Massachusetts General Hospital Terminated No outcome recorded
Phase 1 NCT04358185 Dec 2018 → Apr 2023 hepatocellular carcinoma Imperial College London Completed No outcome recorded
Phase 1 NCT03497273 Mar 2018 → Nov 2019 acute graft versus host disease Incyte Corporation Completed No outcome recorded
Phase 1 NCT03320642 Feb 2018 → Feb 2021 hematopoietic and lymphoid cell neoplasm Incyte Corporation Terminated No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT04061421 Nov 2021 → Aug 2027 expected myelodysplastic/myeloproliferative neoplasm Michael Savona Recruiting No outcome recorded
Phase 1/2 NCT04220632 Jun → Oct 2020 acute graft versus host disease Innovent Biologics (Suzhou) Co. Ltd. Terminated No outcome recorded
Phase 1/2 NCT03978637 Feb 2020 → Oct 2023 bronchiolitis obliterans syndrome Incyte Corporation Terminated No outcome recorded
Phase 1/2 NCT03721965 Dec 2019 → Feb 2020 acute graft versus host disease Incyte Corporation Terminated No outcome recorded
Phase 1/2 NCT03697408 Feb 2019 → May 2024 overdue classic Hodgkin lymphoma University of Pennsylvania Active not recruiting No outcome recorded
Phase 1/2 NCT02760485 Dec 2016 → Jun 2022 large B-cell lymphoma Incyte Corporation Completed No outcome recorded
Phase 1/2 NCT02917993 Dec 2016 → Dec 2025 lung cancer Incyte Corporation Completed No outcome recorded
Phase 1/2 NCT02018861 Sep 2016 → Apr 2021 B-cell neoplasm Incyte Corporation Completed No outcome recorded
Phase 1/2 NCT01858883 Jun 2013 → Feb 2016 malignant pancreatic neoplasm Incyte Corporation Completed No outcome recorded
Phase 226 trials
Phase 2 NCT05757219 May 2023 → Jun 2026 overdue diffuse large B-cell lymphoma H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 2 NCT05660421 Mar 2023 → Apr 2025 cancer, hematopoietic and lymphoid cell neoplasm Douglas Johnson Withdrawn No outcome recorded
Phase 2 NCT04789850 Feb 2023 → Feb 2026 overdue systemic sclerosis Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 2 NCT05364762 Nov 2022 → Mar 2027 expected acute lymphoblastic leukemia, acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome +2 City of Hope Medical Center Active not recruiting No outcome recorded
Phase 2 NCT05063110 May 2022 → Apr 2025 hemophagocytic syndrome Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 2 NCT04859946 Jan 2022 → Apr 2027 expected hematologic disorder M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04629508 Jul 2021 → Aug 2023 acquired polycythemia vera, myelofibrosis, thrombocytosis disease Incyte Corporation Completed No outcome recorded
Phase 2 NCT04640025 Mar 2021 → May 2026 chronic graft versus host disease, myelofibrosis, transplant-related bronchiolitis obliterans Incyte Corporation Terminated No outcome recorded
Phase 2 NCT04446182 Jan 2021 → Mar 2022 chronic graft versus host disease University of Utah Terminated No outcome recorded
Phase 2 NCT04339101 Nov 2020 → May 2023 acute leukemia, myelodysplastic syndrome, myelofibrosis, primary myelofibrosis City of Hope Medical Center Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03584516 Jan 2019 → Nov 2023 chronic graft versus host disease Incyte Corporation Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT03139604 Jul 2017 → May 2019 acute graft versus host disease Incyte Corporation Completed No outcome recorded
Phase not stated2 trials
NCT05561985 Incyte Corporation Available No outcome recorded
NCT03906318 aplastic anemia Incyte Corporation No longer available No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT02265510 Background Sep 2014 → Feb 2019 metastatic malignant neoplasm Incyte Corporation Terminated No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2020-01-02 Incyte Corporation Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease incyte.com
2019-01-22 Incyte Corporation Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease incyte.com
2017-07-20 Incyte Corporation Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host Disease incyte.com

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 57 sources stand behind the page.

FieldValueCited text
Known as ITACITINIB “This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs).” NCT05063110
51

“Treatment with the JAK1 inhibitor itacitinib resulted in a rapid resolution of aplastic anemia” PMID 35590143 Jan 2022

NCT05660421

NCT02257619

NCT04446182

NCT01626573

NCT04220632

NCT03425006

NCT02646748

NCT04061421

NCT03584516

NCT03721965

NCT04200365

NCT03627052

NCT03978637

NCT04339101

NCT05823571

NCT02018861

NCT03139604

NCT03320642

NCT03697408

NCT05561985

NCT01905813

NCT03670069

NCT04629508

NCT04509700

NCT05757219

NCT04127721

NCT04070781

NCT05364762

NCT01634087

NCT02355431

NCT02614612

NCT04789850

NCT01633372

NCT04859946

NCT04239989

NCT03989466

NCT04071366

NCT01858883

NCT03497273

NCT04358185

NCT02917993

NCT05063110

NCT03755414

NCT04640025

NCT04591431

NCT02456675

NCT02559492

NCT02760485

NCT03144687

NCT03846479

Known as INCB-039110 ADIPATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3622820
Known as Incb-39110 ChEMBL registry synonym — accepted as the source's own label CHEMBL3622820
Known as INCB039110 “Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression” NCT05823571
5

“Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.” NCT02559492

“itacitinib (formerly INCB039110), a selective JAK1 inhibitor” PMID 29695516 Apr 2018

NCT03272464

NCT02265510

NCT02909569

Known as itacitinib (INCB039110) itacitinib (INCB039110)NCT01905813
1

itacitinib (INCB039110)NCT02018861

Known as Itacitinib Adipate “Drug: Itacitinib AdipateNCT04339101
Action Inhibit “a potent and selective oral JAK1 inhibitor” PMID 27789678 Oct 2016
Modality Small molecule “a JAK 1 selective small molecule inhibitor” NCT03425006
Route Oral “a potent and selective oral JAK1 inhibitor” PMID 27789678 Oct 2016
Target JAK1 “a potent and selective oral JAK1 inhibitor” PMID 27789678 Oct 2016