Fabry Disease

Rare Diseases
33
Pipeline Programs
8
Companies
50
Clinical Trials
4 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
3
8
0
11
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 46 programs with unclassified modality

On Market (2)

Approved therapies currently available

Sanofi
FABRAZYMEApproved
agalsidase beta
Sanofi
Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]intravenous2003
Amicus Therapeutics
GALAFOLDApproved
migalastat hydrochloride
Amicus Therapeutics
oral2018

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Amicus Therapeutics
Amicus TherapeuticsPA - Philadelphia
28 programs
5
6
8
1
Migalastat HCl 150 mgPhase 31 trial
Migalastat HCl 20 mgPhase 31 trial
migalastat HCl 150 mgPhase 31 trial
migalastat HCl 150 mgPhase 31 trial
migalastat HCl 150 mgPhase 31 trial
+23 more programs
Active Trials
NCT03838237CompletedEst. Jan 2021
NCT04281537CompletedEst. May 2022
NCT04602364CompletedEst. Jun 2023
+25 more trials
Sanofi
SanofiPARIS, France
9 programs
1
1
1
1
Agalsidase betaPhase 41 trial
Agalsidase betaPhase 35 trials
GZ/SAR402671Phase 23 trials
IohexolPhase 11 trial
26 common Fabry mutation types in TaiwanN/A1 trial
+4 more programs
Active Trials
NCT02859363Unknown700Est. Aug 2017
NCT00196742Recruiting9,000Est. Jan 2034
NCT06325488Recruiting60Est. Jun 2026
+12 more trials
Takeda
TakedaTOKYO, Japan
4 programs
1
2
1
ReplagalPhase 41 trial
REPLAGALPhase 31 trial
agalsidase alfaPhase 31 trial
ReplagalPhase 25 trials
Active Trials
NCT01031173No Longer Available
NCT04974749Completed20Est. Jan 2024
NCT01304277Completed17Est. Dec 2012
+5 more trials
4D Molecular Therapeutics
2 programs
2
4D-310Phase 1/21 trial
4D-310Phase 1/21 trial
Active Trials
NCT05629559Recruiting18Est. Jun 2030
NCT04519749Active Not Recruiting18Est. Jun 2030
R
ResVerlogiXAB - Calgary
1 program
1
RVX000222Phase 1/21 trial
Active Trials
NCT03228940Withdrawn0Est. Nov 2022
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
GC1119Phase 11 trial
Active Trials
NCT01653444CompletedEst. Oct 2015
Alliance Pharmaceuticals
2 programs
Implantable Loop RecorderN/A1 trial
MigalastatN/ASmall Molecule1 trial
Active Trials
NCT03305250Active Not Recruiting169Est. Jul 2027
NCT03949920Unknown21Est. Dec 2023
C
CENTOGENEGermany - Rostock
1 program
The Efficacy and Safety of Switch Between Agalsidase Beta to Agalsidase Alfa for Enzyme Replacement N/A1 trial
Active Trials
NCT01268241Completed200Est. Apr 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
TakedaReplagal
SanofiAgalsidase beta
SanofiAgalsidase beta
SanofiAgalsidase beta
SanofiAgalsidase beta
SanofiAgalsidase beta
Amicus TherapeuticsMigalastat HCl 20 mg
Amicus Therapeuticsmigalastat HCl 150 mg
SanofiAgalsidase beta
TakedaReplagal
TakedaREPLAGAL
Amicus Therapeuticsmigalastat HCl 150 mg
Amicus TherapeuticsMigalastat HCl 150 mg
Amicus Therapeuticsmigalastat HCl 150 mg
Amicus Therapeuticsmigalastat hydrochloride

Showing 15 of 48 trials with date data

Clinical Trials (50)

Total enrollment: 871 patients across 50 trials

A Study of Replagal in Children and Adults With Fabry Disease in India

Start: Nov 2022Est. completion: Nov 20265 patients
Phase 4Recruiting
NCT00230607SanofiAgalsidase beta

Study of the Effects of Fabrazyme Treatment on Lactation and Infants

Start: May 2006Est. completion: Feb 20247 patients
Phase 4Terminated
NCT00312767SanofiAgalsidase beta

A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.

Start: Apr 20060
Phase 4Withdrawn
NCT00140621SanofiAgalsidase beta

A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease

Start: Jul 2005Est. completion: Aug 20126 patients
Phase 4Completed
NCT00081497SanofiAgalsidase beta

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Start: Jan 2004Est. completion: Sep 200567 patients
Phase 4Completed
NCT00074984SanofiAgalsidase beta

A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease

Start: Feb 2001Est. completion: Jan 200482 patients
Phase 4Completed
NCT06904261Amicus TherapeuticsMigalastat HCl 20 mg

A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants

Start: Jan 2026Est. completion: Dec 2028
Phase 3Recruiting
NCT04020055Amicus Therapeuticsmigalastat HCl 150 mg

A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease

Start: Oct 2022Est. completion: Dec 2026
Phase 3Active Not Recruiting
NCT05280548SanofiAgalsidase beta

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

Start: May 2022Est. completion: Dec 2027104 patients
Phase 3Active Not Recruiting

A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease

Start: May 2022Est. completion: Jan 202420 patients
Phase 3Completed

A Study of Replagal in Treatment-naïve Adults With Fabry Disease

Start: Dec 2021Est. completion: Dec 202217 patients
Phase 3Terminated
NCT04049760Amicus Therapeuticsmigalastat HCl 150 mg

Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease

Start: Oct 2019Est. completion: Nov 2024
Phase 3Completed
NCT03500094Amicus TherapeuticsMigalastat HCl 150 mg

Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)

Start: Sep 2018Est. completion: Feb 2021
Phase 3Completed
NCT02194985Amicus Therapeuticsmigalastat HCl 150 mg

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

Start: Mar 2015Est. completion: Oct 2019
Phase 3Completed
NCT01458119Amicus Therapeuticsmigalastat hydrochloride

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

Start: Oct 2011Est. completion: Feb 2016
Phase 3Terminated
NCT01218659Amicus Therapeuticsmigalastat hydrochloride

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

Start: Sep 2011Est. completion: May 2015
Phase 3Completed
NCT01298141Takedaagalsidase alfa

A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

Start: Aug 2011Est. completion: Sep 2017171 patients
Phase 3Completed

Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease

Start: Apr 2010Est. completion: Jul 201335 patients
Phase 3Completed
NCT00925301Amicus Therapeuticsmigalastat hydrochloride

Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease

Start: Oct 2009Est. completion: Jan 2014
Phase 3Completed

Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

Start: Dec 2008Est. completion: Jul 201244 patients
Phase 3Completed
NCT00701415SanofiAgalsidase beta

A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms

Start: Sep 2008Est. completion: Jun 201531 patients
Phase 3Completed
NCT00074971SanofiAgalsidase beta

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Start: Oct 1999Est. completion: Dec 200458 patients
Phase 3Completed
NCT02489344SanofiGZ/SAR402671

Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease

Start: Jul 2015Est. completion: Nov 20188 patients
Phase 2Completed
NCT02228460SanofiGZ/SAR402671

Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease

Start: Nov 2014Est. completion: Sep 201611 patients
Phase 2Completed

This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.

Start: Nov 2011Est. completion: Dec 201217 patients
Phase 2Completed

Safety Study of Replagal® Therapy in Children With Fabry Disease

Start: May 2011Est. completion: Apr 201315 patients
Phase 2Completed

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

Start: Feb 2011Est. completion: Oct 2012
Phase 2Completed

Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study

Start: Sep 2007Est. completion: Sep 2012
Phase 2Terminated

A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease

Start: Sep 2006Est. completion: May 2008
Phase 2Completed

A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Start: Jun 2006Est. completion: May 2008
Phase 2Completed

A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Start: May 2006Est. completion: Mar 2008
Phase 2Completed

A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Start: Jan 2006Est. completion: Jan 2008
Phase 2Completed

Replagal Enzyme Replacement Therapy for Children With Fabry Disease

Start: Jun 2004Est. completion: Jun 201117 patients
Phase 2Completed
NCT00196716SanofiAgalsidase beta

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Start: Jun 2003Est. completion: Mar 200721 patients
Phase 2Completed
NCT00837824SanofiAgalsidase beta

Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme

Start: Dec 2002Est. completion: Aug 200320 patients
Phase 2Terminated
NCT00074958SanofiAgalsidase beta

A Study of Fabrazyme in Pediatric Patients With Fabry Disease

Start: Oct 2002Est. completion: Jul 200516 patients
Phase 2Completed

Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease

Start: Nov 2022Est. completion: Nov 20220
Phase 1/2Withdrawn

4D-310 in Adults With Fabry Disease and Cardiac Involvement

Start: Oct 2022Est. completion: Jun 203018 patients
Phase 1/2Recruiting

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease

Start: Sep 2020Est. completion: Jun 203018 patients
Phase 1/2Active Not Recruiting
NCT03687554SanofiGZ/SAR402671

Effect of Venglustat in Patients With Renal Impairment

Start: Oct 2018Est. completion: Feb 201924 patients
Phase 1Completed

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

Start: Mar 2014Est. completion: Jun 2014
Phase 1Completed

A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

Start: May 2013Est. completion: Sep 201639 patients
Phase 1Terminated

Evaluate the Safety and Exploratory Efficacy of GC1119

Start: Nov 2012Est. completion: Oct 2015
Phase 1Completed

Migalastat Food Effect Study

Start: Oct 2011Est. completion: Dec 2011
Phase 1Completed
NCT01853852Amicus TherapeuticsGR181413A/AT1001 solution

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

Start: Sep 2011Est. completion: Dec 2011
Phase 1Completed

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

Start: Aug 2011Est. completion: Apr 2012
Phase 1Completed

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

Start: Aug 2011Est. completion: Sep 2011
Phase 1Completed

Treatment Protocol of Replagal for Patients With Fabry Disease

N/ANo Longer Available
NCT01476163Amicus Therapeuticsmigalastat HCl 150 mg

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

N/AAvailable

A Study of Patients With Fabry Disease (US Specific)

Start: Feb 2026Est. completion: Jun 2032
N/ARecruiting

Related Jobs in Rare Diseases

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

11 late-stage (Phase 3) programs — potential near-term approvals
4 actively recruiting trials targeting 871 patients
8 companies competing in this space