{"id":"elx-tez-iva","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Headache"},{"rate":"10-20","effect":"Nausea"},{"rate":"10-20","effect":"Diarrhea"},{"rate":"5-15","effect":"Rash"},{"rate":"5-10","effect":"Elevated transaminases"}]},"_chembl":{"chemblId":"CHEMBL4297744","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Elexacaftor (ELX) is a CFTR corrector that helps the protein fold properly and traffic to the cell surface. Tezacaftor (TEZ) is another corrector that enhances this effect. Ivacaftor (IVA) is a potentiator that increases the open probability of the CFTR channel once it reaches the cell membrane. Together, these three agents address multiple defects in CFTR function caused by F508del and other mutations.","oneSentence":"ELX/TEZ/IVA is a triple combination of CFTR modulators that work together to restore function of the cystic fibrosis transmembrane conductance regulator protein.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:11.560Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cystic fibrosis in patients aged 6 years and older with at least one F508del-CFTR mutation"},{"name":"Cystic fibrosis in patients with other CFTR mutations responsive to CFTR modulation"}]},"trialDetails":[{"nctId":"NCT05153317","phase":"PHASE3","title":"Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2022-01-17","conditions":"Cystic 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With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2021-10-27","conditions":"Cystic Fibrosis","enrollment":597},{"nctId":"NCT04545515","phase":"PHASE3","title":"A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2021-01-11","conditions":"Cystic Fibrosis","enrollment":120},{"nctId":"NCT04058366","phase":"PHASE3","title":"Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2019-12-05","conditions":"Cystic 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It is classified as a 80S Ribosome modulator, a type of MODULATOR drug.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}