{"id":"oral-fedratinib","safety":{"commonSideEffects":[{"rate":"44%","effect":"Thrombocytopenia"},{"rate":"42%","effect":"Anemia"},{"rate":"34%","effect":"Fatigue"},{"rate":"32%","effect":"Nausea"},{"rate":"29%","effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL4297216","moleculeType":"Small molecule","molecularWeight":"615.63"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Fedratinib is a potent and selective inhibitor of JAK2, which is involved in the signaling of various cytokines and growth factors.","oneSentence":"JAK2 inhibitor","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:41:31.703Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Myeloproliferative neoplasm"}]},"trialDetails":[{"nctId":"NCT04282187","phase":"PHASE2","title":"Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms","status":"RECRUITING","sponsor":"University of Washington","startDate":"2020-03-24","conditions":"Acute Myeloid Leukemia, Essential Thrombocythemia, Myelodysplastic Syndrome","enrollment":25},{"nctId":"NCT05393674","phase":"PHASE2","title":"Fedratinib in Combination With Nivolumab","status":"ACTIVE_NOT_RECRUITING","sponsor":"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest","startDate":"2022-06-14","conditions":"Primary Myelofibrosis, Secondary Myelofibrosis","enrollment":30},{"nctId":"NCT05177211","phase":"PHASE2","title":"Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2022-03-01","conditions":"Myeloproliferative Neoplasm, Chronic Neutrophilic Leukemia, MDS","enrollment":25},{"nctId":"NCT05127174","phase":"PHASE1","title":"Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms","status":"TERMINATED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2022-03-14","conditions":"Myeloproliferative Neoplasm","enrollment":12},{"nctId":"NCT04446650","phase":"PHASE1, PHASE2","title":"A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2020-10-12","conditions":"Primary Myelofibrosis","enrollment":31},{"nctId":"NCT04562870","phase":"PHASE2","title":"A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Karyopharm Therapeutics Inc","startDate":"2021-03-17","conditions":"Myelofibrosis","enrollment":112},{"nctId":"NCT04629508","phase":"PHASE2","title":"To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)","status":"COMPLETED","sponsor":"Incyte Corporation","startDate":"2021-07-12","conditions":"Myelofibrosis, Polycythemia Vera, Thrombocythemia","enrollment":4},{"nctId":"NCT01836705","phase":"PHASE1","title":"Effect of SAR302503 on ECG Activity in Patients With Solid Tumors","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2013-05","conditions":"Neoplasm Malignant","enrollment":60},{"nctId":"NCT01420783","phase":"PHASE2","title":"Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2011-10","conditions":"Hematopoietic Neoplasm","enrollment":81},{"nctId":"NCT00724334","phase":"PHASE1, PHASE2","title":"A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2008-07","conditions":"Myelofibrosis","enrollment":42},{"nctId":"NCT01762462","phase":"PHASE1","title":"Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2012-12","conditions":"Hepatic Impairment","enrollment":17},{"nctId":"NCT01420770","phase":"PHASE2","title":"Phase 2 Study of SAR302503 in Patients With Myelofibrosis","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2011-08","conditions":"Hematopoietic Neoplasm","enrollment":30},{"nctId":"NCT01437787","phase":"PHASE3","title":"Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2011-12","conditions":"Hematopoietic Neoplasm","enrollment":289},{"nctId":"NCT01523171","phase":"PHASE2","title":"Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2012-04","conditions":"Hematopoietic Neoplasm","enrollment":97},{"nctId":"NCT01585623","phase":"PHASE1","title":"Drug Interaction Study of SAR302503 in Patients With Solid Tumor","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2012-06","conditions":"Solid Tumor","enrollment":16},{"nctId":"NCT01692366","phase":"PHASE2","title":"Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2012-11","conditions":"Myelofibrosis","enrollment":8},{"nctId":"NCT01763190","phase":"PHASE1","title":"Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2012-11","conditions":"Renal Impairment","enrollment":36},{"nctId":"NCT05524857","phase":"PHASE1","title":"Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)","status":"TERMINATED","sponsor":"Joseph Jurcic","startDate":"2022-01-28","conditions":"Myeloproliferative Neoplasm","enrollment":2},{"nctId":"NCT03983161","phase":"PHASE1","title":"A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment","status":"COMPLETED","sponsor":"Celgene","startDate":"2019-09-04","conditions":"Healthy Volunteers, Hepatic Impairment","enrollment":39},{"nctId":"NCT05051553","phase":"PHASE1","title":"A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2021-09-21","conditions":"Healthy Volunteers","enrollment":58},{"nctId":"NCT03723148","phase":"","title":"Individual Patient Compassionate Use of Fedratinib","status":"AVAILABLE","sponsor":"Celgene","startDate":"","conditions":"Myelofibrosis","enrollment":""},{"nctId":"NCT04231435","phase":"PHASE1","title":"Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin","status":"COMPLETED","sponsor":"Celgene","startDate":"2019-12-18","conditions":"Healthy Volunteers","enrollment":24},{"nctId":"NCT00631462","phase":"PHASE1","title":"A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis","status":"COMPLETED","sponsor":"TargeGen","startDate":"2008-01","conditions":"Myelofibrosis","enrollment":59}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":43,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["FEDR"],"phase":"phase_2","status":"active","brandName":"Oral Fedratinib","genericName":"Oral Fedratinib","companyName":"Celgene","companyId":"celgene","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fedratinib is a small molecule inhibitor that targets the tyrosine-protein kinase JAK2. It is being studied for the treatment of myelofibrosis and other hematopoietic neoplasms, including acute myeloid leukemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}