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ClinicalTrials.gov 9 recruiting now full pipeline

Fabry Disease: full-pipeline trial registry

9 of 33 indexed Fabry Disease trials are currently recruiting.

Corpus placement: #463 of 28,707 conditions by registered trial count.

33 US clinical trials · 9 currently recruiting · #463 of 28,707 conditions by registered trial count

Fabry Disease: 33 US clinical trials tracked, 9 recruiting.

Fabry Disease is the subject of 33 registered US clinical trials on ClinicalTrials.gov, 9 of them currently open to new participants. 11 are in Phase 3-4 (later-stage) and 10 in Phase 1-2 (earlier-stage). The most active sponsor is Amicus Therapeutics, running 8 of these trials.

Enrollment posture brief

Registry condition fabry-disease

OPEN 9 | RECR 27% | LATE 11 | EARLY 10 | RANK #463 | SPON 8

Nearest open-share peer: Atherosclerotic Cardiovascular Disease (27% recruiting · 22 trials)

Barrett Esophagus54.5%Clinical Stage IV Cutaneous 45.5%Child Development39.4%Fabry Disease (this)27%Anatomic Stage IIB Breast Ca24.2%
Open-enrollment share among volume-matched conditions near Fabry Disease

Fabry Disease lists 9 open slots (27% of 33 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →

Key findings

What ClinicalTrials.gov does not surface for Fabry Disease on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.

  1. Fabry Disease is recruiting below its size-band peers.

    9 of 33 indexed trials (27.3%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.

  2. One sponsor concentrates Fabry Disease research.

    Amicus Therapeutics accounts for 8 of 33 trials (24.2%). 14 distinct sponsors appear on at least one study for this condition label.

  3. Most Fabry Disease trials plan to enrol fewer than 100 people.

    Median target enrolment is 29 among the 33 trials that report a genuine target (sentinel values excluded). 24 of those (72.7%) plan for fewer than 100 participants.

  4. Fabry Disease splits between interventional and observational designs.

    22 interventional and 11 observational studies make up this index (66.7% interventional). Study type is sponsor-reported on ClinicalTrials.gov.

Phase 13Phase 27Phase 310Phase 41

Open and recent trials

33 total, page 1 of 1

RECRUITING 9,000 participants

Fabry Disease Registry & Pregnancy Sub-registry

Genzyme, a Sanofi Company

NCT00196742

RECRUITING 450 participants

A Study of Patients With Fabry Disease (US Specific)

Amicus Therapeutics

NCT06906367

RECRUITING 100 participants

A Multi-Country Observational Study of Safety and Effectiveness of Elfabrio® in Fabry Patients

Chiesi Farmaceutici S.p.A.

NCT06663358

RECRUITING 50 participants

Natural History and Structural Functional Relationships in Fabry Renal Disease Treatment Outcomes(Changes)in Fabry Renal Disease Study

University of Minnesota

NCT01581424

RECRUITING Phase 2 22 participants

A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease

Chiesi Farmaceutici S.p.A.

NCT06328608

RECRUITING 20 participants

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Amicus Therapeutics

NCT04252066

RECRUITING Phase 1 12 participants

Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease

UniQure Biopharma B.V.

NCT06270316

RECRUITING 10 participants

Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Chiesi Farmaceutici S.p.A.

NCT06941025

RECRUITING Phase 3 8 participants

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

Amicus Therapeutics

NCT06904261

ACTIVE NOT RECRUITING Phase 3 122 participants

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

Sanofi

NCT05206773

ACTIVE NOT RECRUITING Phase 3 107 participants

A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease

Idorsia Pharmaceuticals

NCT03737214

ACTIVE NOT RECRUITING Phase 3 104 participants

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

Sanofi

NCT05280548

ACTIVE NOT RECRUITING Phase 3 29 participants

Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

Chiesi Farmaceutici S.p.A.

NCT03614234

ACTIVE NOT RECRUITING Phase 1 18 participants

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

4D Molecular Therapeutics

NCT04519749

ACTIVE NOT RECRUITING Phase 3 14 participants

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

Amicus Therapeutics

NCT04020055

COMPLETED 4,000 participants

Fabry Outcome Survey (FOS)

Shire

NCT03289065

COMPLETED 2,724 participants

Fabry Screening Study

Baylor Research Institute

NCT01019629

COMPLETED NA 102 participants

Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan

Massachusetts General Hospital

NCT02985710

COMPLETED Phase 3 78 participants

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

Protalix

NCT02795676

COMPLETED Phase 3 68 participants

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

Amicus Therapeutics

NCT01218659

COMPLETED Phase 3 67 participants

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

Amicus Therapeutics

NCT00925301

COMPLETED 36 participants

The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study

University of Alabama at Birmingham

NCT00446862

COMPLETED Phase 3 35 participants

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

Shire

NCT01124643

COMPLETED Phase 1 32 participants

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

Amicus Therapeutics

NCT01730469

COMPLETED Phase 2 25 participants

Alternative Dosing and Regimen of Replagal to Treat Fabry Disease

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00075244

COMPLETED Phase 2 25 participants

An Open-Label Clinical Trial of Replagal Enzyme Therapy in Children Ages 7-17 Years With Fabry Disease

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00071877

COMPLETED Phase 4 25 participants

Replagal Enzyme Replacement Therapy for Adults With Fabry Disease

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00097890

COMPLETED 24 participants

PET Scans in Normal Volunteers and Patients With Fabry Disease

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00005111

COMPLETED Phase 2 20 participants

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

Amicus Therapeutics

NCT01196871

COMPLETED Phase 2 15 participants

Safety Study of Replagal® Therapy in Children With Fabry Disease

Shire

NCT01363492

COMPLETED Phase 2 13 participants

Dosing Study of Replagal in Patients With Fabry Disease

Baylor Research Institute

NCT00068107

COMPLETED 12 participants

Antiproteinuric Agents and Fabry Disease

University of Alabama at Birmingham

NCT00343577

COMPLETED Phase 2 3 participants

Alpha-Galactosidase A Replacement Therapy for Fabry Disease

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00048906

Phase Distribution

PhaseTrial count
Phase 1 3
Phase 2 7
Phase 3 10
Phase 4 1

Named interventions

Most-linked intervention names on Fabry Disease records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.

Replagal Drug
4 trials
migalastat hydrochloride Drug
2 trials
Venglustat (GZ402671) Drug
2 trials
Placebo Drug
2 trials
AT1001 150 mg Drug
1 trials
Replagal (Agalsidase Alfa) Drug
1 trials
DRX005B Drug
1 trials
enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers Drug
1 trials

US sites by state

Facility locations filed on Fabry Disease trials. A trial with sites in several states counts in each.

Virginia 17 trials
Georgia 16 trials
Alabama 12 trials
Pennsylvania 10 trials
Utah 9 trials
Texas 9 trials
California 9 trials
Iowa 8 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

What to do with this Fabry Disease page

33 registered trials, 9 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This Fabry Disease condition card totals 33 registered trials; most-linked intervention Replagal; top US site state Virginia. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.