Drug Profile

Itacitinib - Incyte Corporation

Alternative Names: IBI-377; INCB-039110; INCB-039110-adipate; INCB-39110; Itacitinib-adipate

Latest Information Update: 12 Feb 2026

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At a glance

Originator Incyte Corporation
Developer ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP); AstraZeneca; H. Lee Moffitt Cancer Center and Research Institute; Incyte Corporation; Innovent Biologics; National Cancer Institute (USA); University of Utah
Class Acetonitriles; Anti-inflammatories; Antianaemics; Antibronchitics; Antineoplastics; Antipsoriatics; Antirheumatics; Azetidines; Fluorocarbons; Piperidines; Pyrazoles; Pyridines; Pyrimidines; Pyrroles; Skin disorder therapies; Small molecules
Mechanism of Action Janus kinase 1 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Graft-versus-host disease
New Molecular Entity Yes

Phase II Cytokine release syndrome; Diffuse large B cell lymphoma; Diffuse scleroderma; Haemophagocytic lymphohistiocytosis; Hodgkin's disease; Immunological disorders; Myelofibrosis; Non-small cell lung cancer
Phase I/II Bronchiolitis obliterans; Haematological malignancies; Myelodysplastic syndromes; Non-Hodgkin's lymphoma; Solid tumours
No development reported Aplastic anaemia; Graft-versus-host disease; Liver cancer; Malignant melanoma; Soft tissue sarcoma; T-cell prolymphocytic leukaemia
Discontinued Pancreatic cancer; Plaque psoriasis; Rheumatoid arthritis

06 Dec 2025 Efficacy and adverse event data from the phase II HLH-JAK trial presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2025)
01 Oct 2025 Assistance Publique - Hôpitaux de Paris completed a phase-II trial in Haemophagocytic lymphohistiocytosis in France (PO) (NCT05063110) (EudraCT2021-000407-20)
30 May 2025 Efficacy data from a phase I trial in Soft tissue sarcoma presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)

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