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Itacitinib - Incyte Corporation

Drug Profile

Itacitinib - Incyte Corporation

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

Latest Information Update: 21 May 2024

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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

Highest Development Phases

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

Most Recent Events

  • 08 May 2024 Fred Hutchinson Cancer Research Center and Incyte Corporation terminate a phase I trial in Soft tissue sarcoma (Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO), due to slow enrollment in the last remaining cohort and a lack of evidence of clinical benefit (NCT03670069)
  • 09 Dec 2023 Updated adverse events data from the phase II trial for Cytokine release syndrome presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
  • 03 Nov 2023 Incyte Corporation terminates the phase-III GRAVITAS-309 trial in Graft-versus-host disease (Combination therapy, Treatment-naïve) in Austria, Belgium, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Israel, Italy, Poland, Spain, Sweden, Switzerland, UK and USA, due to insufficient efficacy to support moving into Part 2 of the study (PO) (NCT03584516),
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