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Trikafta FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 13, 2023.

FDA Approved: Yes (First approved October 21, 2019)
Brand name: Trikafta
Generic name: elexacaftor/tezacaftor/ivacaftor and ivacaftor
Dosage form: Tablets and Oral Granules
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

Development timeline for Trikafta

Apr 26, 2023Approval Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations
Jun  9, 2021Approval Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
Dec 21, 2020Approval Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations
Oct 21, 2019Approval FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation
Aug 20, 2019FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
Jul 22, 2019Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
May 30, 2019Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis

Further information

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