{"id":"turalio","rwe":[{"pmid":"40616288","year":"2025","title":"Real-world experience of patients newly initiated on pexidartinib for tenosynovial giant cell tumor.","finding":"","journal":"Future oncology (London, England)","studyType":"Clinical Study"},{"pmid":"40554835","year":"2025","title":"Characterizing the metabolites of the tyrosine-kinase inhibitor pexidartinib in mouse feces, urine, plasma, and liver.","finding":"","journal":"Journal of pharmaceutical and biomedical analysis","studyType":"Clinical Study"},{"pmid":"40438996","year":"2025","title":"TURALIO® Risk Evaluation and Mitigation Strategy (tREMS) program: 5-year retrospective hepatic safety assessment.","finding":"","journal":"Future oncology (London, England)","studyType":"Clinical Study"},{"pmid":"40254734","year":"2025","title":"Vimseltinib (Romvimza) for tenosynovial giant cell tumor.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"},{"pmid":"40163687","year":"2025","title":"Patient-reported continued benefits of pexidartinib for tenosynovial giant cell tumor based on a real-world study in the United States.","finding":"","journal":"The oncologist","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Daiichi Sankyo","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Increased lactate dehydrogenase","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased aspartate aminotransferase","drugRate":"","severity":"common","organSystem":""},{"effect":"Hair color changes","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased alanine aminotransferase","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased neutrophils","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased cholesterol","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased alkaline phosphatase","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased lymphocytes","drugRate":"","severity":"common","organSystem":""},{"effect":"Eye edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased hemoglobin","drugRate":"","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysgeusia","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased phosphate","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"4.9%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"3.3%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"3.3%","severity":"common","organSystem":""},{"effect":"Blurred vision","drugRate":"","severity":"common","organSystem":""},{"effect":"Photophobia","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Abnormal liver tests","drugRate":"3.3%","severity":"serious"},{"effect":"Hepatotoxicity","drugRate":"3.3%","severity":"serious"},{"effect":"Increased ALT","drugRate":"4.9%","severity":"serious"},{"effect":"Increased AST","drugRate":"4.9%","severity":"serious"},{"effect":"Increased bilirubin","drugRate":"3.3%","severity":"serious"},{"effect":"Increased GGT","drugRate":"3.3%","severity":"serious"},{"effect":"Cholangitis","drugRate":"","severity":"serious"},{"effect":"Liver disorder","drugRate":"","severity":"serious"},{"effect":"Cognitive disorders","drugRate":"","severity":"serious"},{"effect":"Photosensitivity reactions","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Daiichi Sankyo","patents":[],"pricing":[],"allNames":["turalio™"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"target":"AP2-associated protein kinase 1, Aurora kinase B, Cyclin-dependent kinase 19","modality":"Small Molecule","explanation":"Imagine your body's cells are like a city with many roads and intersections. Turalio is like a traffic cop that helps regulate the flow of traffic by blocking certain roads, which can help slow down the growth of abnormal cells. This can be beneficial in treating certain diseases, but more research is needed to understand its full effects.","oneSentence":"Turalio works by inhibiting a specific biological pathway.","technicalDetail":"Turalio's exact mechanism of action is unknown, but it is believed to work by inhibiting a specific enzyme or protein that plays a role in cell growth and proliferation."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=turalio%E2%84%A2","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=turalio™","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:27:24.544193","biosimilars":[],"competitors":[],"genericName":"turalio™","indications":{"approved":[{"name":"Tenosynovial giant cell tumor","diseaseId":"tenosynovial-giant-cell-tumor","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04703322","phase":"PHASE2","title":"A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan","status":"ACTIVE_NOT_RECRUITING","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2021-03-15","conditions":["Tenosynovial Giant Cell Tumor"],"enrollment":9,"completionDate":"2026-05-31"},{"nctId":"NCT04635111","phase":"","title":"A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment","status":"RECRUITING","sponsor":"Daiichi Sankyo","startDate":"2021-01-07","conditions":["Hepatotoxicity","Tenosynovial Giant Cell Tumor"],"enrollment":30,"completionDate":"2036-06-01"},{"nctId":"NCT04488822","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT","status":"ACTIVE_NOT_RECRUITING","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2020-09-25","conditions":["Tenosynovial Giant Cell Tumor"],"enrollment":40,"completionDate":"2026-02-28"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Daiichi Sankyo","relationship":"Original Developer"}],"publicationCount":18,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"originalDeveloper":"Daiichi Sankyo","recentPublications":[{"date":"2025 Aug","pmid":"40616288","title":"Real-world experience of patients newly initiated on pexidartinib for tenosynovial giant cell tumor.","journal":"Future oncology (London, England)"},{"date":"2025 Nov 15","pmid":"40554835","title":"Characterizing the metabolites of the tyrosine-kinase inhibitor pexidartinib in mouse feces, urine, plasma, and liver.","journal":"Journal of pharmaceutical and biomedical analysis"},{"date":"2025 Jun","pmid":"40438996","title":"TURALIO® Risk Evaluation and Mitigation Strategy (tREMS) program: 5-year retrospective hepatic safety assessment.","journal":"Future oncology (London, England)"},{"date":"2025 Jan 6","pmid":"40254734","title":"Vimseltinib (Romvimza) for tenosynovial giant cell tumor.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2025 Mar 10","pmid":"40163687","title":"Patient-reported continued benefits of pexidartinib for tenosynovial giant cell tumor based on a real-world study in the United States.","journal":"The oncologist"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"TURALIO™","companyName":"Daiichi Sankyo","companyId":"daiichi-sankyo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Turalio is a small molecule drug developed by Daiichi Sankyo, but its target, drug class, and approved indications are unknown. As a small molecule, it is a type of medication that can be taken orally and is designed to interact with specific biological pathways. The commercial status of Turalio is unclear, and it is not known whether it is patented or has generic manufacturers. Further information on its safety considerations and pharmacological properties is also unavailable. As a result, Turalio remains a relatively unknown entity in the pharmaceutical industry.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}