Ruxolitinib phosphate is under clinical development by Incyte and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ruxolitinib phosphate’s likelihood of approval (LoA) and phase transition for Diffuse Large B-Cell Lymphoma took place on 07 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ruxolitinib phosphate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ruxolitinib phosphate overview

Ruxolitinib (INCB18424, Jakafi, Jakavi) is an anti neoplastic, immunomodulating and anti inflammatory agent. It is formulated as tablets for oral administration. Ruxolitinib is indicated for patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis. It is also indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Ruxolitinib is indicated as emergency use for the treatment of COVID-19. Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.

Ruxolitinib phosphate is under development for the treatment of vitiligo, discoid lupus erythematosus (DLE), metastatic advanced cutaneous squamous cell carcinoma, idiopathic hypereosinophilic syndrome, atopic dermatitis, hemophagocytic lymphohistiocytosis, COVID-19 patients with defined hyperinflammation and primary eosinophilic disorders, polycythemia vera, relapsed/refractory multiple myeloma, Hodgkin lymphoma, relapsed/refractory acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), chronic myelocytic leukemia (CML), bronchiolitis obliterans syndrome, myelodysplastic syndrome, acute myelocytic leukemia (AML), Myelofibrosis, Hematopoietic Stem Cell Transplantation and Graft Versus Host Disease (GVHD), diffuse large B-cell lymphoma, essential thrombocythemia, peripheral T-cell lymphomas, head and neck squamous cell carcinoma including oral cavity cancer, oropharngeal cancer, hypopharyngeal cancer and laryngeal cancer, CLL as first line therapy and breast biopsy showing ADH (atypical ductal hyperplasia), ALH (atypical lobular hyperplasia), LCIS (lobular carcinoma in situ), or DCIS (ductal carcinoma in situ), inflammatory triple negative breast cancer, plaque psoriasis, chronic active Epstein-Barr virus infection (CAEBV), Lichen sclerosus, unspecified dermatological disorders (cutaneous lichen planus), hidradenitis suppurativa and Coronavirus infections and cytokine storm. It is administered through cutaneous route.

It was also under development for early myelofibrosis, cancer cachexia, metastatic prostate cancer, rheumatoid arthritis, metastatic colorectal cancer and metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, metastatic HER2 negative breast cancer, lung adenocarcinoma, adenocarcinoma, metastatic colorectal cancer, acute respiratory distress syndrome, chronic hand eczema and thalassemia.

Incyte overview

Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, non-small cell lung cancer, b-cell malignancies, solid tumors, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

Quick View Ruxolitinib phosphate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ruxolitinib phosphate
Administration Pathway
  • Oral
  • Topical
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Oncology
  • Respiratory
  • Women’s Health
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.