{"id":"osimertinib-osi","safety":{"commonSideEffects":[{"rate":"55","effect":"Diarrhea"},{"rate":"35","effect":"Rash"},{"rate":"25","effect":"Dry skin"},{"rate":"20","effect":"Nausea"},{"rate":"15","effect":"Stomatitis"},{"rate":"10","effect":"Paronychia"},{"rate":"5","effect":"QTc prolongation"},{"rate":"2","effect":"Interstitial lung disease"}]},"_chembl":null,"_dailymed":{"setId":"5e81b4a7-b971-45e1-9c31-29cea8c87ce7","title":"TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Osimertinib selectively targets activating EGFR mutations (exon 19 deletions and L858R) and the T790M resistance mutation that emerges during first- or second-generation EGFR inhibitor treatment. By covalently binding to the ATP-binding pocket of mutant EGFR, it prevents autophosphorylation and downstream proliferation signals, while showing reduced activity against wild-type EGFR, thereby improving tolerability. This mechanism makes it effective in both treatment-naïve and resistant EGFR-mutant non-small cell lung cancers.","oneSentence":"Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations, blocking downstream signaling in cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:13:15.069Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations (first-line)"},{"name":"Metastatic non-small cell lung cancer with EGFR T790M mutation (second-line, after progression on first- or second-generation EGFR inhibitors)"},{"name":"Adjuvant treatment of stage IB-IIIA EGFR-mutant non-small cell lung cancer after resection"}]},"trialDetails":[{"nctId":"NCT07005102","phase":"PHASE2, PHASE3","title":"A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-08-03","conditions":"Non-Squamous Non-Small Cell Lung Cancer","enrollment":854},{"nctId":"NCT04141644","phase":"PHASE1","title":"Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Utah","startDate":"2020-08-20","conditions":"Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)","enrollment":24},{"nctId":"NCT03543683","phase":"PHASE2","title":"Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC","status":"COMPLETED","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","startDate":"2018-01-01","conditions":"Non-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, EGFR T790M","enrollment":115},{"nctId":"NCT06018688","phase":"PHASE2","title":"Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.","status":"NOT_YET_RECRUITING","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","startDate":"2023-09-15","conditions":"Non Small Cell Lung Cancer, EGFR Gene Mutation","enrollment":44},{"nctId":"NCT03989115","phase":"PHASE1, PHASE2","title":"Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC","status":"COMPLETED","sponsor":"Revolution Medicines, Inc.","startDate":"2019-07-02","conditions":"Solid Tumor","enrollment":113},{"nctId":"NCT03532698","phase":"","title":"Combination of Osimertinib and Aspirin to Treat Osimertinib Resistance Non-small Cell Lung Cancer ( NSCLC)","status":"UNKNOWN","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","startDate":"2020-08-01","conditions":"Non-Small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage IV, EGFR T790M","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Osimertinib (Osi)","genericName":"Osimertinib (Osi)","companyName":"AbbVie","companyId":"abbvie","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations, blocking downstream signaling in cancer cells. Used for Metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations (first-line), Metastatic non-small cell lung cancer with EGFR T790M mutation (second-line, after progression on first- or second-generation EGFR inhibitors), Adjuvant treatment of stage IB-IIIA EGFR-mutant non-small cell lung cancer after resection.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}