Drug Profile

Ruxolitinib - Incyte Corporation/Novartis

Alternative Names: INC-424; INCB 018424 phosphate; INCB-018424; INCB-18424; Jakafi; Jakavi; Opzelura; RUX; ruxolitinib phosphate

Latest Information Update: 23 Sep 2025

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At a glance

Originator Incyte Corporation
Developer Baylor Breast Care Center; CMS Medical; Dana-Farber Cancer Institute; H. Lee Moffitt Cancer Center and Research Institute; Incyte Corporation; Lymphoma Academic Research Organisation; National Cancer Institute (USA); Novartis; RWTH Aachen University; University Health Network of Toronto; University of Cologne; University of Rochester; University of Texas M. D. Anderson Cancer Center; Washington University School of Medicine
Class 2 ring heterocyclic compounds; Anti-inflammatories; Antianaemics; Antibronchitics; Antihaemorrhagics; Antineoplastics; Antipsoriatics; Antirheumatics; Antivirals; Cyclopentanes; Nitriles; Pyrazoles; Pyrimidines; Pyrroles; Skin disorder therapies; Small molecules
Mechanism of Action Janus kinase 1 inhibitors; Janus kinase 2 inhibitors

Orphan Drug Status

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

Yes - Myelofibrosis; Pancreatic cancer; Polycythaemia vera; Essential thrombocythaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Graft-versus-host disease
New Molecular Entity Yes

Marketed Atopic dermatitis; Graft-versus-host disease; Myelofibrosis; Polycythaemia vera; Vitiligo
Phase III Cytokine release syndrome; Essential thrombocythaemia; Hidradenitis suppurativa; Prurigo nodularis; SARS-CoV-2 acute respiratory disease
Phase II/III COVID-19 pneumonia
Phase II Acute myeloid leukaemia; Alopecia areata; Breast cancer; Breast disorders; Bronchiolitis obliterans; Cachexia; Chronic lymphocytic leukaemia; Chronic myeloid leukaemia; Chronic myelomonocytic leukaemia; Discoid lupus erythematosus; Haematological malignancies; Head and neck cancer; HIV infections; Hodgkin's disease; Lichen planus; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma; Thalassaemia; Vulvar lichen sclerosus
Phase I/II Anaemia; HER2 positive breast cancer; Multiple myeloma
Phase I Adenocarcinoma
No development reported Psoriasis
Discontinued Colorectal cancer; HER2 negative breast cancer; Non-small cell lung cancer; Pancreatic cancer; Prostate cancer; Rheumatoid arthritis

18 Sep 2025 Registered for Atopic dermatitis (In children) in USA (Topical)
07 Aug 2025 Novartis terminates the phase I/II ADORE trial in Myelofibrosis (Combination therapy) in Australia, Spain, Belgium, Canada, Denmark, Hungary, Israel, Italy, Japan, South Korea, Netherlands, Romania, Russia, Sweden, Switzerland, Turkey, United Kingdom and Germany (PO), due to sponsor decision (NCT04097821)
17 Jul 2025 Incyte Corporation completes a phase I trial for Prurigo nodularis in USA (Topical, Cream) (NCT06213831)

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