KALYDECO

Peak

ivacaftor

NDAORALTABLETPriority Review
Approved
Jan 2012
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
21

Mechanism of Action

Chloride Channel Activation Potentiators

Pharmacologic Class:

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator

Clinical Trials (5)

NCT07349394Phase 1Active Not Recruiting

Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants

Started Jan 2026
18 enrolled
Cystic Fibrosis
NCT07022327N/AActive Not Recruiting

Ivacaftor Impact in an Adolescent Without a Cystic Fibrosis-Associated CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Mutation for Chronic Pancreatitis: Single-Patient Study Tracking Flare Frequency and Health Data Compared to Historical Records.

Started May 2025
1 enrolled
Chronic Pancreatitis
NCT06299696Phase 1Completed

A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists

Started Mar 2024
10 enrolled
Cystic Fibrosis
NCT06299709Phase 1Completed

A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)

Started Mar 2024
34 enrolled
Cystic Fibrosis
NCT05844449Phase 3Enrolling By Invitation

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

Started Aug 2023
174 enrolled
Cystic Fibrosis

Loss of Exclusivity

LOE Date
Feb 13, 2030
48 months away
Patent Expiry
Feb 13, 2030
Exclusivity Expiry
Jun 21, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
8354427
Jul 6, 2026
U-1311
8754224
Dec 28, 2026
SubstanceProduct
9670163
Dec 28, 2026
Product
U-1311
8410274
Dec 28, 2026
Product
8354427*PED
Jan 6, 2027