Tezacaftor
- Generic Name
- Tezacaftor
- Brand Names
- Symdeko, Trikafta (100 Mg / 50 Mg / 75 Mg; 150 Mg)
- Drug Type
- Small Molecule
- Chemical Formula
- C26H27F3N2O6
- CAS Number
- 1152311-62-0
- Unique Ingredient Identifier
- 8RW88Y506K
- Background
Tezacaftor is a drug of the cystic fibrosis transmembrane conductance regulator (CFTR) potentiator class. It was developed by Vertex Pharmaceuticals and FDA approved in combination with ivacaftor to manage cystic fibrosis. This drug was approved by the FDA on February 12, 2018.
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- Indication
Tezacaftor is combined with ivacaftor in one product for the treatment of cystic fibrosis (CF) in patients aged 12 years or older with two copies of the F508del gene mutation or at least one mutation in the CFTR gene that is responsive to this drug.
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- Associated Conditions
- Cystic Fibrosis (CF)
- Associated Therapies
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FDA approves Alyftrek once-daily oral combination for cystic fibrosis
The FDA approved Alyftrek, a once-daily oral combination for cystic fibrosis in adults and children aged 6 and older. It is Vertex Pharmaceuticals' fifth CFTR modulator, offering efficacy in 31 additional mutations and lower sweat chloride levels than TRIKAFTA. The approval is based on a comprehensive Phase 3 program involving over 1,000 patients globally, demonstrating non-inferiority to TRIKAFTA and significant improvements in sweat chloride levels.
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor
Vertex announces FDA approval for TRIKAFTA to include 94 additional non-F508del CFTR mutations, expanding eligibility to 300 more U.S. cystic fibrosis patients for the first time.
Can We Pick Winners With Causal Human Biology? Vertex Makes the Case
Vertex Pharmaceuticals developed a therapy for cystic fibrosis, challenging low drug development odds. Their R&D strategy focuses on causal human biology, using human genomics and modality agnosticism to improve success rates, exemplified by FDA approvals for CF, sickle cell disease, and beta thalassemia treatments.
The impact of the COVID-19 pandemic and the changing landscape of CF on the cASPerCF trial
Studies on cystic fibrosis (CF) treatments, including triple therapy for Phe508del-gating and -residual function genotypes, efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor combination regimen, and factors influencing clinical trial participation for CF patients.
Vertex Highlights First Oral Presentation of Phase 3 Clinical Data of the Vanzacaftor Triple Combination
Vertex Pharmaceuticals announced Phase 3 data on the investigational vanzacaftor triple combination, demonstrating noninferiority to TRIKAFTA® in ppFEV1 and improved CFTR function. Presentations at the North American Cystic Fibrosis Conference (NACFC) also highlighted long-term benefits of TRIKAFTA®, including pancreatic function improvement in young patients. The vanzacaftor triple combination has been submitted for regulatory approval in multiple countries.
Vertex Announces Health Canada Acceptance of New Drug Submission for Vanzacaftor
Vertex Pharmaceuticals announced Health Canada's review of its NDS for vanzacaftor/tezacaftor/deutivacaftor, a once-daily triple combination therapy for CF patients aged 6+ with at least one F508del mutation or another responsive mutation in the CFTR gene.
Drug Development Updates
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