{"id":"vx-121-tez-d-iva","safety":{"commonSideEffects":[{"rate":"null","effect":"Upper respiratory tract infection"},{"rate":"null","effect":"Nausea"},{"rate":"null","effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This triple combination aims to improve CFTR function by correcting misfolded CFTR proteins, potentiating the activity of residual CFTR proteins, and amplifying the activity of CFTR proteins. This approach has the potential to improve lung function and reduce pulmonary exacerbations in patients with cystic fibrosis.","oneSentence":"VX-121/TEZ/D-IVA is a triple combination of a cystic fibrosis transmembrane conductance regulator (CFTR) corrector (VX-121), a CFTR potentiator (tezacaftor), and a CFTR amplifier (ivacaftor).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:54:56.030Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cystic fibrosis in patients with one or two Phe508del alleles"},{"name":"Cystic fibrosis in patients with one F508del allele and one minimal function mutation"}]},"trialDetails":[{"nctId":"NCT07349394","phase":"PHASE1","title":"Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2026-01-12","conditions":"Cystic Fibrosis","enrollment":18},{"nctId":"NCT05844449","phase":"PHASE3","title":"Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older","status":"ENROLLING_BY_INVITATION","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2023-08-11","conditions":"Cystic Fibrosis","enrollment":174},{"nctId":"NCT05422222","phase":"PHASE3","title":"Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age","status":"RECRUITING","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2022-06-21","conditions":"Cystic Fibrosis","enrollment":210},{"nctId":"NCT06299709","phase":"PHASE1","title":"A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2024-03-13","conditions":"Cystic Fibrosis","enrollment":34},{"nctId":"NCT05444257","phase":"PHASE3","title":"A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2022-11-08","conditions":"Cystic Fibrosis","enrollment":822},{"nctId":"NCT05033080","phase":"PHASE3","title":"A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2021-09-14","conditions":"Cystic Fibrosis","enrollment":435},{"nctId":"NCT05076149","phase":"PHASE3","title":"A Study of VX-121 Combination Therapy in Participants 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":"NCT06299696","phase":"PHASE1","title":"A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2024-03-26","conditions":"Cystic Fibrosis","enrollment":10},{"nctId":"NCT03912233","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2019-04-30","conditions":"Cystic Fibrosis","enrollment":87},{"nctId":"NCT05437120","phase":"PHASE1","title":"Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2022-07-22","conditions":"Cystic Fibrosis","enrollment":16},{"nctId":"NCT05535959","phase":"PHASE1","title":"A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2022-09-15","conditions":"Cystic Fibrosis","enrollment":16},{"nctId":"NCT03768089","phase":"PHASE1, PHASE2","title":"Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis","status":"COMPLETED","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2018-03-20","conditions":"Cystic Fibrosis","enrollment":115}],"_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":["VX-121/VX-661/CTP-656","VX-121/VX-661/VX-561","VX-121/tezacaftor/deutivacaftor"],"phase":"phase_3","status":"active","brandName":"VX-121/TEZ/D-IVA","genericName":"VX-121/TEZ/D-IVA","companyName":"Vertex Pharmaceuticals Incorporated","companyId":"vertex-pharmaceuticals-incorporated","modality":"Small molecule","firstApprovalDate":"","aiSummary":"VX-121/TEZ/D-IVA is a triple combination of a cystic fibrosis transmembrane conductance regulator (CFTR) corrector (VX-121), a CFTR potentiator (tezacaftor), and a CFTR amplifier (ivacaftor). Used for Cystic fibrosis in patients with one or two Phe508del alleles, Cystic fibrosis in patients with one F508del allele and one minimal function mutation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}