Fedratinib is under clinical development by Bristol-Myers Squibb and currently in the Phase II 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 Fedratinib’s likelihood of approval (LoA) and phase transition for Myelodysplastic Syndrome took place on 19 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Fedratinib overview

Fedratinib (Inrebic, Fedratinib dihydrochloride) is an antineoplastic agent. It is formulated as hard gelatin capsules, hard capsules for oral route of administration. Fedratinib is indicated for the treatment of adult patients with intermediate-2  or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Treatment of splenomegaly or disease associated symptoms in patients who have failed ruxolitinib or who could not tolerate it with primary myelofibrosis, or with secondary myelofibrosis as a complication of polycythemia vera or essential thrombocythemia.

Fedratinib (SAR-302503) is under development for myelofibrosis, primary and secondary myelofibrosis, atypical chronic myeloid leukemia, myelodysplastic syndrome and chronic neutrophilic leukemia. It was also under development for high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis in Japan.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

Quick View Fedratinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Fedratinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Oncology
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.