21 completed, 9 terminated, 1 recruiting, 1 withdrawn. 19 Phase 2, 10 Phase 3, 2 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 12, Terminated 5, Recruiting 1, Withdrawn 1 |
| Phase 3 | 10 | Completed 6, Terminated 4 |
| Phase 1 | 2 | Completed 1, Recruiting 1 |
| Phase 4 | 2 | Completed 2 |
Follow ataluren: new trials by email Literature Review of ataluren trials Research Report on ataluren
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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety and Pharmacokinetics of Ataluren in Participants From ≥6 Months to <2 Years of Age With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Ataluren - Nonsene Mutation Duchenne Muscular Dystrophy | Phase 2 | Completed | PTC Therapeutics | 6 | 2021-12-29 | 2024-04-01 |
| Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study Ataluren + Pembrolizumab - Colorectal Cancer, Endometrium Cancer | Phase 1 / Phase 2 | Recruiting | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 47 | 2019-08-01 | 2023-02-01 |
| A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have Been Treated With Ataluren Ataluren - Duchenne Muscular Dystrophy | Phase 2 | Completed | PTC Therapeutics | 6 | 2019-04-11 | 2022-04-05 |
| A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia Ataluren - Aniridia | Phase 2 | Withdrawn | PTC Therapeutics | 2018-12-31 | 2019-10-07 | |
| A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Ataluren - Duchenne Muscular Dystrophy | Phase 2 | Completed | PTC Therapeutics | 20 | 2018-12-21 | 2022-04-05 |
| Long-Term Outcomes of Ataluren in Duchenne Muscular Dystrophy Ataluren, PLACEBO - Muscular Dystrophy, Duchenne, Muscular Dystrophies | Phase 3 | Completed | PTC Therapeutics | 360 | 2017-07-06 | 2026-03-10 |
| Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense Mutations Ivacaftor/Ataluren - Cystic Fibrosis | Phase 4 | Completed | University of Alabama at Birmingham | 1 | 2017-03-17 | 2019-07-19 |
| PTC Study to Evaluate Ataluren in Combination With Ivacaftor Ataluren - Cystic Fibrosis | Phase 4 | Completed | University of Alabama at Birmingham | 1 | 2017-01-27 | 2020-03-26 |
| Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome ataluren, Placebo - Epilepsy | Phase 2 | Completed | NYU Langone Health | 15 | 2016-11-01 | 2023-02-16 |
| Study of Ataluren in ≥2 to <5 Year-Old Male Participants With Duchenne Muscular Dystrophy Ataluren - Duchenne Muscular Dystrophy | Phase 2 | Completed | PTC Therapeutics | 14 | 2016-06-09 | 2020-08-28 |
| Study of Ataluren in Participants With Nonsense Mutation Aniridia Ataluren, Placebo - Aniridia | Phase 2 | Completed | PTC Therapeutics | 39 | 2016-01-31 | 2022-05-27 |
| Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis Ataluren - Cystic Fibrosis | Phase 3 | Terminated | PTC Therapeutics | 246 | 2015-08-31 | 2020-04-27 |
| Effects of Rifampin on the Pharmacokinetics of Ataluren Ataluren, Rifampin - Healthy | Phase 1 | Completed | PTC Therapeutics | 15 | 2015-02-01 | 2017-12-22 |
| Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF) Ataluren (PTC124®), Placebo - Cystic Fibrosis | Phase 3 | Completed | PTC Therapeutics | 279 | 2014-08-01 | 2020-05-14 |
| Study of Ataluren (PTC124) in Cystic Fibrosis Ataluren - Cystic Fibrosis | Phase 3 | Terminated | PTC Therapeutics | 61 | 2014-05-23 | 2020-03-25 |
| An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy Ataluren - Muscular Dystrophy, Duchenne, Muscular Dystrophies | Phase 3 | Terminated | PTC Therapeutics | 219 | 2014-03-20 | 2020-08-11 |
| Phase 3 Study of Ataluren in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Ataluren, Placebo - Muscular Dystrophy, Duchenne, Muscular Dystrophies | Phase 3 | Completed | PTC Therapeutics | 230 | 2013-03-26 | 2020-08-04 |
| Study of Ataluren for Previously Treated Participants With Nonsense Mutation Duchenne/Becker Muscular Dystrophy (nmDBMD) in Europe, Israel, Australia, and Canada Ataluren - Duchenne Muscular Dystrophy, Becker Muscular Dystrophy | Phase 3 | Completed | PTC Therapeutics | 94 | 2012-05-20 | 2020-11-25 |
| Study of Ataluren in Previously Treated Participants With Nonsense Mutation Dystrophinopathy (nmDBMD) Ataluren - Duchenne Muscular Dystrophy | Phase 3 | Terminated | PTC Therapeutics | 265 | 2010-11-22 | 2026-10-08 |
| Extension Study of Ataluren (PTC124) in Cystic Fibrosis Ataluren - Cystic Fibrosis | Phase 3 | Completed | PTC Therapeutics | 191 | 2010-08-12 | 2020-10-19 |
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Muscular Dystrophy, Duchenne (13) · Cystic Fibrosis (11) · Genetic Diseases, Inborn (3) · Genetic Diseases, X-Linked (3) · Muscular Diseases (3) · Muscular Disorders, Atrophic (3) · Muscular Dystrophies (3) · Musculoskeletal Diseases (3) · Nervous System Diseases (3) · Neuromuscular Diseases (3) · Aniridia (2) · Amino Acid Metabolism, Inborn Errors (1) · Colorectal Neoplasms (1) · Endometrial Neoplasms (1) · Epilepsy (1)
PTC Therapeutics (28) · University of Alabama at Birmingham (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · NYU Langone Health (1)
United States (24) · Canada (14) · France (13) · Belgium (12) · Israel (12) · Italy (12) · United Kingdom (11) · Germany (10) · Spain (10) · Australia (8) · Sweden (8) · Brazil (5) · Netherlands (5) · Poland (5) · Bulgaria (4)
Francesco Bibbiani, MD (3) · Joseph McIntosh, MD (3) · Jay Barth, MD (2) · Leone Atkinson, MD, PhD (2) · Steven M Rowe, MD (2) · Temitayo Ajayi, MD (2) · Vinay Penematsa, MD (2) · Adriaan D Bins, MD PhD (1) · Edward O'Mara, MD (1) · Eitan Kerem, MD (1) · Eiten Kerem, MD (1) · Francesco Bibbiani, M.D. (1) · Isabelle Sermet-Gaudelus, MD (1) · John P Clancy, MD (1) · Leone Atkinson (1)
PMID 36866921, PMID 32851872, PMID 34693725, PMID 17389552, PMID 17450125, PMID 18722008, PMID 20622033, PMID 21233271, PMID 24349052, PMID 24836205, PMID 28728956, PMID 30135256, PMID 31983658, PMID 32682670, PMID 33538404, PMID 34383312, PMID 34791888, PMID 37236246, PMID 40983668, PMID 41879641
2019 (2), 2008 (1), 2009 (1), 2017 (1)