22 completed, 4 terminated, 1 active not recruiting, 1 available. 13 Phase 2, 9 Phase 3, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 11, Terminated 2 |
| Phase 3 | 9 | Completed 5, Terminated 2, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 6 | Completed 6 |
Follow larazotide acetate: new trials by email Literature Review of larazotide acetate trials Research Report on larazotide acetate
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 of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants Migalastat HCl 20 mg - Fabry Disease | Phase 3 | Recruiting | Amicus Therapeutics | 8 | 2026-01-08 | 2026-10-22 |
| AT1001 for the Treatment of Long COVID Larazotide Acetate, Placebo - Long COVID, Long COVID-19 | Phase 2 | Completed | Massachusetts General Hospital | 107 | 2023-05-31 | 2026-08-18 |
| A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease migalastat HCl 150 mg - Fabry Disease | Phase 3 | Active not recruiting | Amicus Therapeutics | 14 | 2022-10-31 | 2026-07-06 |
| AT1001 for the Treatment of COVID-19 Related MIS-C Larazotide Acetate, Placebo - Covid19, Multisystem Inflammatory Syndrome in Children | Phase 2 | Terminated | Massachusetts General Hospital | 12 | 2021-10-01 | 2024-06-13 |
| Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease migalastat HCl 150 mg - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 16 | 2019-10-11 | 2026-02-05 |
| Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms Larazotide, Matching Placebo - Celiac Disease | Phase 3 | Terminated | 9 Meters Biopharma, Inc. | 307 | 2019-05-29 | 2022-07-26 |
| Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years) Migalastat HCl 150 mg - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 22 | 2018-09-27 | 2021-11-30 |
| Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease migalastat HCl 150 mg - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 84 | 2015-03-14 | 2020-12-21 |
| A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers IV migalastat HCl, IV placebo, oral migalastat HCl - Fabry Disease | Phase 1 | Completed | Amicus Therapeutics | 31 | 2014-03-01 | 2014-06-18 |
| A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease Larazotide Acetate, placebo - Celiac Disease | Phase 2 | Completed | 9 Meters Biopharma, Inc. | 342 | 2011-11-07 | 2017-09-20 |
| Open-Label Phase 3 Long-Term Safety Study of Migalastat migalastat hydrochloride - Fabry Disease | Phase 3 | Terminated | Amicus Therapeutics | 85 | 2011-10-14 | 2018-10-02 |
| Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease migalastat hydrochloride, agalsidase - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 68 | 2011-09-08 | 2018-11-01 |
| A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects GR181413A/AT1001 solution, GR181413A/AT1001 capsule, Potable water - Fabry Disease | Phase 1 | Completed | Amicus Therapeutics | 14 | 2011-09-01 | 2013-12-18 |
| A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014) [14C] AT1001 - Fabry Disease | Phase 1 | Completed | Amicus Therapeutics | 6 | 2011-08-01 | 2013-12-18 |
| Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function AT1001 150 mg - Fabry Disease | Phase 1 | Completed | Amicus Therapeutics | 32 | 2011-08-01 | 2017-08-03 |
| Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease Migalastat HCl, Agalsidase Beta, Agalsidase Alfa - Fabry Disease | Phase 2 | Completed | Amicus Therapeutics | 20 | 2011-02-02 | 2018-12-19 |
| Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease migalastat hydrochloride, Placebo - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 67 | 2009-10-23 | 2018-10-30 |
| Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease Larazotide acetate, Placebo, Gluten 900 mg - Celiac Disease | Phase 2 | Completed | 9 Meters Biopharma, Inc. | 42 | 2009-04-01 | 2017-09-20 |
| Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease larazotide acetate, placebo - Celiac Disease | Phase 2 | Completed | 9 Meters Biopharma, Inc. | 105 | 2008-02-01 | 2017-09-20 |
| Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study migalastat HCl - Fabry Disease | Phase 2 | Terminated | Amicus Therapeutics | 23 | 2007-09-17 | 2018-10-03 |
Showing 20 of 29. Sign in to see all of them.
Fabry Disease (19) · Celiac Disease (8) · Lysosomal Storage Diseases (2) · COVID-19 (1) · Kidney Diseases (1) · Kidney Failure, Chronic (1) · Motor Activity (1) · Post-Acute COVID-19 Syndrome (1) · Renal Insufficiency (1) · pediatric multisystem inflammatory disease, COVID-19 related (1)
Amicus Therapeutics (19) · 9 Meters Biopharma, Inc. (8) · Massachusetts General Hospital (2)
United States (23) · United Kingdom (11) · Australia (10) · Canada (9) · Brazil (7) · France (7) · Spain (6) · Belgium (5) · Denmark (4) · Italy (4) · Japan (4) · Argentina (3) · Egypt (3) · Turkey (Türkiye) (3) · Austria (2)
Blake Paterson, MD (2) · Francisco Leon, MD, Ph.D (1) · Francisco Leon, MD, Ph.D. (1) · Francisco Leon, MD, PhD (1) · Henrik Rasmussen, MD, PhD (1)
PMID 27657681, PMID 23176611, PMID 27509102, PMID 31889231, PMID 32994552, PMID 17697209, PMID 22825365, PMID 23163616, PMID 23474038, PMID 25683116, PMID 26252393, PMID 27136905, PMID 27536442, PMID 27834756, PMID 29703262, PMID 30723321, PMID 31934472, PMID 33012654, PMID 40737433
2009 (1), 2014 (1), 2017 (1), 2019 (1)