Fedratinib · Inrebic, SAR-302503

What is Fedratinib?

Fedratinib is an oral ATP-competitive kinase inhibitor that selectively targets JAK2 and FLT3. It inhibits JAK-STAT signaling and induces apoptosis in cells with JAK2 mutations or FLT3 overexpression, treating intermediate-2 or high-risk myelofibrosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Inrebic, SAR-302503, TG-101348

Drug type

Small molecule

Targets

JAK2, FLT3 (secondary target)

Mechanism

Inhibitor of JAK2

Pathways

JAK-STAT signaling, apoptosis

Therapy area

Hematology

Developer

Bristol-Myers

In trials of

IBO, SNDX

FDA status

Approved as Inrebic (August 16, 2019), NDA212327 · FDA label

UNII

6L1XP550I6

✅ FDA-approved uses

• Intermediate-2 or high-risk primary or secondary myelofibrosis

From the indications section of the FDA label (version of Jul 20, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Post-essential Thrombocythemia MyelofibrosisPost-polycythemia Vera MyelofibrosisMyelofibrosisPost-Polycythemia VeraPrimary Myelofibrosis

Other drugs acting on JAK2

Sources

• FDA label (DailyMed)
• FDA label Inrebic (2026-07-20), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT03952039
• ClinicalTrials.gov NCT07734077

Updated Oct 3, 2026.