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, pills for oral administration. Ruxolitinib is indicated for patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythaemia 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, metastatic castration-resistant prostate cancer, cancer anorexia-cachexia syndrome, discoid lupus erythematosus (DLE), secondary myelofibrosis, metastatic advanced cutaneous squamous cell carcinoma, idiopathic hyper eosinophilic syndrome,  hemophagocytic lymph histiocytosis, COVID-19 patients with defined hyperinflammation and primary eosinophilic disorders, polycythaemia 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), anti-PD1 induced lichenoid skin toxicities, essential thrombocythemia, 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, chronic active Epstein-Barr virus infection (CAEBV), and Coronavirus infections and cytokine storm. It is administered through cutaneous route.

It was also under development for diffuse large B-cell lymphoma, early myelofibrosis, cachexia, metastatic prostate cancer, peripheral T-cell lymphomas (PTCL), 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, head and neck squamous cell carcinoma including oral cavity cancer, oropharngeal cancer, hypopharyngeal cancer and laryngeal cancer and thalassemia.

Incyte overview

Incyte is a biopharmaceutical company, that 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, b-cell malignancies, solid tumors, non-small cell lung cancer, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

For a complete picture of Ruxolitinib phosphate’s drug-specific PTSR and LoA scores, buy the report here.

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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.