Product Description
Fedratinib is a JAK2-selective kinase inhibitor recently approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with intermediate-2 or high-risk myelofibrosis (MF). (Sourced from: https://ashpublications.org/bloodadvances/article/4/8/1792/454549/Fedratinib-in-myelofibrosis)
Mechanisms of Action: JAK2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States
Approved Indications: Myelofibrosis | Polycythemia | Thrombocythemia, Essential | Polycythemia Vera
Known Adverse Events: Anemia | Diarrhea
Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Poland, Romania, Russia, Spain, United Kingdom, United States
Active Clinical Trial Count: 14
Highest Development Phases
Phase 3: Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential|Thrombocytosis
Phase 2: Acute Respiratory Distress Syndrome|Leukemia, Neutrophilic, Chronic|Myelodysplastic Syndrome|Myelodysplastic-Myeloproliferative Diseases|Myeloproliferative Disorders
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2020-002071-35 | P2 |
Active, not recruiting |
Myelofibrosis |
2030-10-26 |
|
| CA011-023 | P2 |
Unknown Status |
Myelofibrosis |
2029-03-22 |
|
| FAMy | P2 |
Active, not recruiting |
Myelofibrosis |
2026-07-29 |
|
| FRACTION_2021 | P2 |
Unknown Status |
Myelofibrosis |
2026-02-27 |