OnCo
drugsProductNot mapped hereapproved

Fedratinib

A second JAK inhibitor for myelofibrosis that works after ruxolitinib fails; it carries a boxed warning for a rare brain toxicity (Wernicke encephalopathy) so thiamine is checked.

JAKARTA (first line) and JAKARTA-2 (post-ruxolitinib) showed spleen responses in ~35-45%. Development was halted in 2013 over encephalopathy cases and resumed after review; approved 2019 with thiamine monitoring.

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Fedratinib
PubChem
Modality
Small-molecule JAK2/FLT3 inhibitor
Mechanism
Selective JAK2 inhibitor (also FLT3, BRD4) reducing JAK-STAT signalling and splenomegaly.
Brand / code
Inrebic
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA756 · 2021SMC: accepted
Appraised for
Myelofibrosis-related splenomegaly or symptoms after ruxolitinib
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA756 · SMC advice: fedratinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2019Intermediate-2/high-risk primary or secondary myelofibrosis
EU2021Myelofibrosis, JAK-inhibitor-naive or after ruxolitinib

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
17 studies2 recruiting14 Phase 23 Phase 3
Search “Fedratinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Fedratinib
intervention: Fedratinib
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Fedratinib" OR ABSTRACT:"Fedratinib" OR TITLE:"Inrebic" OR ABSTRACT:"Inrebic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fedratinib, not a curated reading list.

Connected

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