This is a new triple CFTR modulator administered once daily for the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del mutation, another agent-sensitive mutation in the CFTR gene (https://www.cff.org/news/2024-12/fda-approves-new-cftr-modulator accessed on 22 October 2025) (FDA criteria) or at least one non-class I mutation in the CFTR gene (EMA criteria). Here, CFTR is linked to cystic fibrosis.