10 completed, 4 active not recruiting, 2 terminated. 8 Phase 1, 5 Phase 2, 4 Phase 3.
By phase and status
Follow venglustat: new trials by email Literature Review of venglustat trials Research Report on venglustat
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 in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function Venglustat (GZ402671) - Hepatic Function Abnormal | Phase 1 | Completed | 26 | 2023-01-18 | 2025-09-15 |
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease Venglustat (GZ402671), Agalsidase alfa, Agalsidase beta (GZ419828) - Fabry Disease | Phase 3 | Active not recruiting | 104 | 2022-05-03 | 2026-06-24 |
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3 Venglustat, imiglucerase - Gaucher's Disease Type III | Phase 3 | Active not recruiting | 43 | 2022-04-18 | 2026-07-13 |
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease Venglustat (GZ402671), Placebo - Fabry Disease | Phase 3 | Active not recruiting | 122 | 2022-03-11 | 2026-10-13 |
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants Venglustat - Healthy Volunteers | Phase 1 | Completed | 65 | 2020-06-23 | 2024-05-17 |
A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants Venglustat - Healthy Volunteers | Phase 1 | Completed | 9 | 2020-06-18 | 2024-05-17 |
Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects venglustat - Disorders of Sphingolipid Metabolism, Healthy Volunteers | Phase 1 | Completed | 6 | 2020-05-26 | 2025-09-17 |
Effect of Venglustat in Patients With Renal Impairment Venglustat GZ/SAR402671 - Healthy Volunteers, Polycystic Kidney, Autosomal Dominant | Phase 1 | Completed | 24 | 2018-10-05 | 2022-04-25 |
A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients Venglustat, Placebo - Polycystic Kidney, Autosomal Dominant | Phase 2 / Phase 3 | Terminated | 478 | 2018-10-04 | 2023-02-03 |
A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants Venglustat, Itraconazole - Healthy Volunteers | Phase 1 | Completed | 8 | 2018-08-16 | 2024-05-20 |
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension venglustat (GZ402671), imiglucerase - Gaucher Disease Type 1, Gaucher Disease Type 3 | Phase 2 | Active not recruiting | 12 | 2017-01-04 | 2026-07-10 |
A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation venglustat GZ/SAR402671, Placebo - Parkinson's Disease | Phase 2 | Terminated | 273 | 2016-12-15 | 2022-05-24 |
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease GZ/SAR402671 - Fabry Disease | Phase 2 | Completed | 8 | 2015-07-07 | 2021-03-23 |
Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease GZ/SAR402671 - Fabry Disease | Phase 2 | Completed | 11 | 2014-11-01 | 2019-12-17 |
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers Genz-682452, Placebo - Healthy | Phase 1 | Completed | 36 | 2012-10-01 | 2014-03-19 |
Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men Genz-682452, Placebo - Healthy Volunteer | Phase 1 | Completed | 63 | 2012-08-01 | 2014-03-19 |
Conditions studied
Fabry Disease (4) · Gaucher Disease (2) · Polycystic Kidney, Autosomal Dominant (2) · Liver Diseases (1) · Parkinson Disease (1)
Sponsors
Genzyme, a Sanofi Company (10) · Sanofi (6)
Countries
United States (15) · United Kingdom (9) · France (7) · Germany (7) · Japan (6) · Canada (5) · Italy (5) · Poland (5) · Austria (4) · China (4) · Turkey (Türkiye) (4) · Argentina (3) · Denmark (3) · Greece (3) · Norway (3)
Results publications
PMID 32851809, PMID 36481125, PMID 34897099, PMID 36204243, PMID 36535535, PMID 37050861, PMID 37479372, PMID 38802634, PMID 39356039
NIH funding
2014 (3), 2023 (2), 2016 (1), 2017 (1), 2019 (1)