Fedratinib

Overview

Fedratinib, also known as SAR302503 and TG101348, is a tyrosine kinase inhibitor used to treat intermediate-2 and high risk primary and secondary myelofibrosis. It is an anilinopyrimidine derivative. Fedratinib was granted FDA approval on August 16, 2019.

Indication

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.

Associated Conditions

Secondary Myelofibrosis
Primary Myelofibrosis (PMF)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis	2023/10/10	NCT06073847	N/A	Recruiting	Bristol-Myers Squibb
Real World Evidence of Fedratinib Effectiveness in MF	2023/06/01	NCT05883904	N/A	Recruiting	Gruppo Italiano Malattie EMatologiche dell'Adulto
Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)	2022/09/01	NCT05524857	Phase 1	Terminated	Joseph Jurcic
Phase II Study of Fedratinib and Nivolumab Combination in Patients with Myelofibrosis and Resistance or Suboptimal Response to JAK-inhibitor Treatment - The FRACTION Trial	2024/10/24	2024-513953-64-00	Phase 2	Active, not recruiting	Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis	2022/05/12	NCT05371964	Phase 1	Recruiting	Geron Corporation
Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)	2022/01/04	NCT05177211	Phase 2	Active, not recruiting	H. Lee Moffitt Cancer Center and Research Institute
Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms	2021/11/19	NCT05127174	Phase 1	Terminated	H. Lee Moffitt Cancer Center and Research Institute
A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants	2021/09/21	NCT05051553	Phase 1	Completed	Bristol-Myers Squibb
A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms	2021/07/09	NCT04955938	Phase 1	Withdrawn	University of Chicago
A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)	2021/03/25	NCT04817007	Phase 1	Active, not recruiting	Bristol-Myers Squibb

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
INREBIC CAPSULES 100 MG	Celgene International Sarl	SIN16617P	CAPSULE	100 mg	9/29/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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