{"id":"nirogacestat-oral-tablet","safety":{"commonSideEffects":[{"rate":"40–50","effect":"Diarrhea"},{"rate":"30–40","effect":"Nausea"},{"rate":"20–30","effect":"Fatigue"},{"rate":"15–25","effect":"Vomiting"},{"rate":"15–20","effect":"Abdominal pain"},{"rate":"10–20","effect":"Decreased appetite"}]},"_chembl":{"chemblId":"CHEMBL4298153","moleculeType":"Small molecule","molecularWeight":"651.48"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gamma-secretase is an intramembrane protease complex that cleaves Notch receptors and other substrates. In desmoid tumors, aberrant Notch signaling promotes fibroblast proliferation and tumor growth. By blocking gamma-secretase activity, nirogacestat suppresses Notch-driven proliferation and induces tumor regression or stabilization. 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Therapies","status":"TERMINATED","sponsor":"Pfizer","startDate":"2014-09-03","conditions":"Metastatic Cancer Pancreas","enrollment":3},{"nctId":"NCT02299635","phase":"PHASE2","title":"A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations","status":"TERMINATED","sponsor":"Pfizer","startDate":"2015-02-03","conditions":"Triple Negative Breast Neoplasms","enrollment":19},{"nctId":"NCT02462707","phase":"PHASE1","title":"A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors","status":"WITHDRAWN","sponsor":"Pfizer","startDate":"2015-07","conditions":"Advanced Solid Tumors","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["PF-03084014","Ogsiveo"],"phase":"phase_3","status":"active","brandName":"Nirogacestat oral tablet","genericName":"Nirogacestat oral tablet","companyName":"SpringWorks Therapeutics, Inc.","companyId":"springworks-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nirogacestat inhibits gamma-secretase, reducing the production of Notch intracellular domain and downstream signaling that drives abnormal cell proliferation in desmoid tumors. Used for Desmoid tumors (aggressive fibromatosis).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}