Ruxolitinib phosphate is under clinical development by Novartis and currently in Phase II for Hemophagocytic Lymphohistiocytosis. According to GlobalData, Phase II drugs for Hemophagocytic Lymphohistiocytosis have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ruxolitinib phosphate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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.
Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.
For a complete picture of Ruxolitinib phosphate’s drug-specific PTSR and LoA scores, buy the report here.