100 completed, 6 recruiting, 6 terminated, 4 active not recruiting. 56 Phase 3, 28 Phase 2, 20 Phase 1, 6 Phase 4, 3 Early Phase 1.
Follow ivacaftor: new trials by email Literature Review of ivacaftor trials Research Report on ivacaftor
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Elexacaftor, Tezacaftor, Ivacaftor, Ivacaftor (VX-770) - Cystic Fibrosis (CF) | Phase 4 | Recruiting | Istituto Giannina Gaslini | 50 | 2026-09-18 | 2026-10-14 |
| Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis VX-581, Placebo, D-IVA - Cystic Fibrosis | Phase 1 | Recruiting | Vertex Pharmaceuticals Incorporated | 152 | 2025-12-09 | 2026-10-19 |
| 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. Ivacaftor 150 MG (milligrams) - Chronic Pancreatitis | Active not recruiting | Mission: Cure | 1 | 2025-05-06 | 2025-06-15 | |
| Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Active not recruiting | Vertex Pharmaceuticals Incorporated | 50 | 2024-11-21 | 2026-06-05 |
| A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF RCT2100, Placebo, Ivacaftor - Cystic Fibrosis | Phase 2 | Active not recruiting | ReCode Therapeutics | 128 | 2024-02-01 | 2026-08-19 |
| Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation - Healthy Volunteer | Phase 1 | Completed | Qanatpharma Canada LTD | 39 | 2023-11-17 | 2023-12-26 |
| Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 67 | 2023-06-27 | 2026-10-15 |
| Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis Trikafta - Non-cystic Fibrosis Bronchiectasis | Phase 4 | Completed | Emory University | 32 | 2023-04-18 | 2026-02-09 |
| Sinus Disease in Young Children With Cystic Fibrosis Ivacaftor or elexacaftor/tezacaftor/ivacaftor - Cystic Fibrosis in Children, Cystic Fibrosis | Recruiting | University of California, Los Angeles | 80 | 2023-04-12 | 2026-09-10 | |
| A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) VX-522 mRNA therapy, IVA - Cystic Fibrosis | Phase 1 / Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 26 | 2023-02-27 | 2026-10-09 |
| Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Active not recruiting | Vertex Pharmaceuticals Incorporated | 297 | 2022-11-23 | 2026-10-09 |
| Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis. Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening - Cystic Fibrosis | Unknown | CHC Montlegia | 20 | 2022-09-01 | 2022-10-31 | |
| Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation ELX/TEZ/IVA, IVA, Placebo (matched to ELX/TEZ/IVA) - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 307 | 2022-05-09 | 2024-08-01 |
| Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 71 | 2022-01-17 | 2026-03-03 |
| A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 86 | 2022-01-14 | 2023-07-11 |
| The Multicenter Topic Trial Ivacaftor - Chronic Obstructive Pulmonary Disease | Phase 2 | Withdrawn | University of Alabama at Birmingham | 2021-12-01 | 2022-01-27 | |
| 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 VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 597 | 2021-10-27 | 2024-06-13 |
| A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF) ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 82 | 2021-10-12 | 2025-09-24 |
| 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) VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 435 | 2021-09-14 | 2024-10-03 |
| Mutation-specific Therapy for the Long QT Syndrome Lumacaftor / Ivacaftor, Orkambi® Oral Tablet - Long QT Syndrome | Phase 2 | Completed | Istituto Auxologico Italiano | 16 | 2021-06-15 | 2025-04-25 |
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Cystic Fibrosis (108) · Fibrosis (4) · Genetic Diseases, Inborn (4) · Infant, Newborn, Diseases (4) · Lung Diseases (4) · Pancreatic Diseases (4) · Pathologic Processes (4) · Respiratory Tract Diseases (4) · Digestive System Diseases (3) · Pulmonary Disease, Chronic Obstructive (3) · Bronchitis, Chronic (2) · Disease (2) · Channelopathies (1) · Ciliary Motility Disorders (1) · Death, Sudden, Cardiac (1)
Vertex Pharmaceuticals Incorporated (92) · University of Alabama at Birmingham (7) · Concert Pharmaceuticals (2) · Eloxx Pharmaceuticals, Inc. (2) · Emory University (2) · Assistance Publique - Hôpitaux de Paris (1) · CHC Montlegia (1) · Children's Hospital of Philadelphia (1) · George Solomon (1) · Hannover Medical School (1) · Istituto Auxologico Italiano (1) · Istituto Giannina Gaslini (1) · Medical University of South Carolina (1) · Mission: Cure (1) · Nottingham University Hospitals NHS Trust (1)
United States (83) · United Kingdom (56) · Australia (49) · Canada (49) · Germany (45) · France (30) · Belgium (29) · Netherlands (27) · Ireland (24) · Spain (20) · Denmark (19) · Italy (19) · Switzerland (15) · Israel (14) · Czechia (13)
H. Frank Farmer, MD (3) · Eric Sorscher, MD (2) · Lana Pilja (2) · Patrick A Flume, MD (2) · Adebayo Lawal, M.D. (1) · Alan Smyth, Prof (1) · Bonnie Ramsey, MD (1) · Bonnie W. Ramsey, MD (1) · Bradford Woodworth, MD (1) · Christine De Boeck, MD, PhD (1) · Daniel M Beswick, MD (1) · Dennis W Nielson, MD, PhD (1) · Dominique Hubert, MD (1)
PMID 37983082, PMID 33331662, PMID 36509366, PMID 25981758, PMID 26070913, PMID 27298017, PMID 30146268, PMID 30334693, PMID 30587335, PMID 36842446, PMID 39756424, PMID 21083385, PMID 22383668, PMID 23590265, PMID 24461666, PMID 24660233, PMID 24973281, PMID 25311995, PMID 26135562, PMID 26803277, PMID 27097977, PMID 27805836, PMID 27898234, PMID 28011037, PMID 28068001, PMID 28132845, PMID 28606620, PMID 28611235, PMID 28651844, PMID 28711222, PMID 29099333, PMID 29099344, PMID 29126871, PMID 29327948, PMID 29886024, PMID 30334692, PMID 31053538, PMID 31253540, PMID 31679946, PMID 31697873, PMID 31784217, PMID 32546431, PMID 32965659, PMID 33023304, PMID 33095038, PMID 33339768, PMID 33581080, PMID 33600745, PMID 33734030, PMID 34437784
2017 (10), 2018 (9), 2016 (5), 2019 (5), 2014 (4), 2015 (3), 2023 (3), 2009 (1), P30DK072482 (1), R01HL133006 (1), R01HL139876 (1), R34HL127166 (1)