9 completed, 2 active not recruiting, 2 withdrawn, 1 not yet recruiting. 8 Phase 3, 3 Phase 4, 2 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 4, Withdrawn 2, Active not recruiting 1, Not yet recruiting 1 |
| Phase 4 | 3 | Completed 3 |
| Phase 2 | 2 | Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 1 | Completed 1 |
Follow imiglucerase: new trials by email Literature Review of imiglucerase trials Research Report on imiglucerase
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 |
|---|---|---|---|---|---|---|
| The Efficacy and Safety of Venglustat Compared With Cerezyme in Pediatric Participants 2 to 11 Years of Age With Gaucher Disease Type 3 (GD3) Venglustat, Imiglucerase - Gaucher's Disease Type III | Phase 3 | Not yet recruiting | Sanofi | 18 | 2026-12-11 | 2026-11-10 |
| An Efficacy and Safety Study of AVR-RD-02 Compared to Enzyme Replacement Therapy for Treatment of Gaucher Disease Type 3 Gene therapy, Enzyme Replacement Agent - Gaucher Disease, Type 3 | Phase 2 / Phase 3 | Withdrawn | AVROBIO | 2023-10-01 | 2023-08-09 | |
| 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 | Sanofi | 43 | 2022-04-18 | 2026-07-13 |
| Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ Cerezyme® / Imiglucerase - Gaucher's Disease | Phase 4 | Completed | Sanofi | 12 | 2021-03-02 | 2025-09-15 |
| A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers Abcertin, EU-sourced Cerezyme - Gaucher Disease | Phase 1 | Completed | ISU Abxis Co., Ltd. | 42 | 2020-01-29 | 2021-04-05 |
| Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3 Eliglustat GZ385660, Imiglucerase GZ437843 - Gaucher's Disease Type I, Gaucher's Disease Type III | Phase 3 | Completed | Sanofi | 57 | 2018-04-11 | 2026-06-16 |
| 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 | Genzyme, a Sanofi Company | 12 | 2017-01-04 | 2026-07-10 |
| Phase III Study of ISU302 in Patients With Type 1 Gaucher Disease ISU302 - Gaucher Disease, Type 1 | Phase 3 | Completed | ISU Abxis Co., Ltd. | 8 | 2011-09-01 | 2017-07-12 |
| The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease Cerezyme®, ISU302 - Gaucher Disease | Phase 3 | Withdrawn | ISU Abxis Co., Ltd. | 2011-01-01 | 2016-08-23 | |
| Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1) Imiglucerase - Gaucher Disease | Completed | University Research Foundation for Lysosomal Storage Diseases, Inc. | 173 | 2010-04-01 | 2015-06-01 | |
| A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE) Eliglustat tartrate, Imiglucerase - Gaucher Disease, Type 1 | Phase 3 | Completed | Genzyme, a Sanofi Company | 160 | 2009-09-01 | 2016-11-25 |
| Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease velaglucerase alfa, imiglucerase - Gaucher Disease, Type 1 | Phase 3 | Completed | Shire | 34 | 2008-01-29 | 2021-06-08 |
| Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease Cerezyme - Gaucher Disease, Type 1, Cerebroside Lipidosis Syndrome | Phase 4 | Completed | Genzyme, a Sanofi Company | 95 | 2001-12-01 | 2015-04-03 |
| A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease. Cerezyme (imiglucerase for injection) - Gaucher Disease Type I, Cerebroside Lipidosis Syndrome | Phase 4 | Completed | Genzyme, a Sanofi Company | 40 | 1997-12-01 | 2015-03-05 |
Gaucher Disease (14)
Genzyme, a Sanofi Company (4) · Sanofi (4) · ISU Abxis Co., Ltd. (3) · AVROBIO (1) · Shire (1) · University Research Foundation for Lysosomal Storage Diseases, Inc. (1)
United States (7) · United Kingdom (6) · Argentina (4) · Canada (4) · Italy (4) · Spain (4) · France (3) · Germany (3) · Japan (3) · Russia (3) · Australia (2) · Brazil (2) · China (2) · Turkey (Türkiye) (2) · Egypt (1)
Amel El Beshlawy, Prof. (1) · Charlotte Lemech, MD (1) · Edward Kaye, M.D. (1) · Milena Veselinovic, MD, PhD (1) · Neal J Weinreb, MD (1)
PMID 25819691, PMID 25994334, PMID 27839979, PMID 28167660, PMID 28219443, PMID 38802634
2008 (1), 2014 (1), 2016 (1), 2023 (1)