Amicus Therapeutics

Amicus Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2002-01-01
Employees
517
Market Cap
$3.3B
Website
http://www.amicusrx.com
Introduction

Amicus Therapeutics, Inc. operates as a biotechnology company. The firm focuses on discovering, developing and delivering medicines for people living with metabolic diseases. Its product portfolio includes first and only approved oral precision medicine for people living with Fabry disease who have amenable genetic variants, a novel, clinical-stage, treatment paradigm for Pompe disease and a rare disease gene therapy portfolio. The company was founded by John Francis Crowley on February 4, 2002 and is headquartered in Princeton, NJ.

Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-07-21
Last Posted Date
2020-12-21
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
84
Registration Number
NCT02194985
Locations
🇬🇧

Clinical Study Site, London, United Kingdom

A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers

First Posted Date
2014-03-10
Last Posted Date
2014-06-18
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
31
Registration Number
NCT02082327
Locations
🇳🇱

PRA International, Groningen, Netherlands

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

First Posted Date
2013-05-15
Last Posted Date
2013-12-18
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
14
Registration Number
NCT01853852
Locations
🇦🇺

GSK Investigational Site, Randwick, New South Wales, Australia

A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-11-21
Last Posted Date
2013-12-18
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
6
Registration Number
NCT01730482

Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-11-21
Last Posted Date
2017-08-03
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
32
Registration Number
NCT01730469
Locations
🇺🇸

GSK Investigational Site, Orlando, Florida, United States

Migalastat Food Effect Study

First Posted Date
2011-12-12
Last Posted Date
2013-12-18
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
20
Registration Number
NCT01489995
Locations
🇺🇸

GSK Investigational Site, Austin, Texas, United States

Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

Conditions
First Posted Date
2011-11-22
Last Posted Date
2019-01-23
Lead Sponsor
Amicus Therapeutics
Registration Number
NCT01476163
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

CHOC Children's Hospital Division of Metabolic Disease, Orange, California, United States

🇦🇺

Royal Melbourne Hospital, Parkville, Victoria, Australia

and more 2 locations

Open-Label Phase 3 Long-Term Safety Study of Migalastat

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2011-10-24
Last Posted Date
2018-10-02
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
85
Registration Number
NCT01458119

Drug-drug Interaction Study

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-06-27
Last Posted Date
2024-07-31
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
25
Registration Number
NCT01380743

Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease

First Posted Date
2010-10-11
Last Posted Date
2018-11-01
Lead Sponsor
Amicus Therapeutics
Target Recruit Count
68
Registration Number
NCT01218659
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