{"entity":{"id":"fedratinib","kind":"drug","name":"Fedratinib","aka":[],"tldr":"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.","summary":"Fedratinib is a selective JAK2 inhibitor, with additional FLT3 and BRD4 activity, that reduces JAK-STAT signalling to shrink the spleen and ease symptoms in myelofibrosis. In JAKARTA (first line) and JAKARTA-2 (after ruxolitinib) about 35 to 45% of patients achieved a spleen response, giving it evidence in ruxolitinib failure. Development was halted in 2013 after cases of encephalopathy and resumed after review; it was approved in the US in 2019 for intermediate-2 or high-risk primary or secondary myelofibrosis and in the EU in 2021, with a boxed warning for Wernicke encephalopathy, so thiamine is checked before and during treatment. Anaemia and thrombocytopenia occur as with other JAK inhibitors. For a newcomer: a myelofibrosis pill that works after ruxolitinib, with a rare brain toxicity that vitamin monitoring prevents.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Fedratinib","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=fedratinib"}],"tags":["gap-fill"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["jak2","flt3","brd4"],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04817007"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Inrebic","modality":"Small-molecule JAK2/FLT3 inhibitor","mechanism":"Selective JAK2 inhibitor (also FLT3, BRD4) reducing JAK-STAT signalling and splenomegaly.","approvals":[{"region":"US","year":2019,"indication":"Intermediate-2/high-risk primary or secondary myelofibrosis"},{"region":"EU","year":2021,"indication":"Myelofibrosis, JAK-inhibitor-naive or after ruxolitinib"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fedratinib/","neighbours":{"cancer":[{"id":"myeloproliferative-neoplasms","kind":"cancer","name":"Myeloproliferative neoplasms (PV, ET, myelofibrosis)","route":"/cancers/myeloproliferative-neoplasms/"},{"id":"primary-myelofibrosis","kind":"cancer","name":"Primary myelofibrosis","route":"/cancers/primary-myelofibrosis/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"brd4","kind":"target","name":"BRD4","route":"/targets/brd4/"},{"id":"flt3","kind":"target","name":"FLT3","route":"/targets/flt3/"},{"id":"jak2","kind":"target","name":"JAK2","route":"/targets/jak2/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct04817007","kind":"trial","name":"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)","route":"/trials/nct04817007/"}],"paper":[{"id":"paper-comfort-1-ruxolitinib-myelofibrosis-nejm-2012","kind":"paper","name":"COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis","route":"/key-papers/paper-comfort-1-ruxolitinib-myelofibrosis-nejm-2012/"}],"term":[{"id":"dipss-mipss70","kind":"term","name":"DIPSS, DIPSS-plus and MIPSS70 (myelofibrosis risk scores)","route":"/terms/dipss-mipss70/"}]}}