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Metabolic & Lysosomal

Metachromatic Leukodystrophy (MLD) Clinical Trials

Also called MLD, Arylsulfatase A Deficiency, ASPA Deficiency

Metachromatic Leukodystrophy results from mutations in the ARSA gene encoding arylsulfatase A or in the PSAP gene encoding prosaposin, a required sulfatide activator protein. ARSA deficiency prevents breakdown of sulfatides, resulting in accumulation of these myelin components in oligodendrocytes, neurons, and peripheral tissues.

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About Metachromatic Leukodystrophy

Metachromatic Leukodystrophy results from mutations in the ARSA gene encoding arylsulfatase A or in the PSAP gene encoding prosaposin, a required sulfatide activator protein. ARSA deficiency prevents breakdown of sulfatides, resulting in accumulation of these myelin components in oligodendrocytes, neurons, and peripheral tissues. Sulfatide accumulation triggers demyelination, neuronal dysfunction, and neuroinflammation. The pattern of sulfatide deposits creates characteristic metachromatic staining under microscopy, which is diagnostic. Disease severity correlates with residual ARSA activity: infantile forms have minimal or absent activity, late-infantile forms have very low activity, and juvenile forms have slightly higher residual activity.

The infantile form is most severe, presenting with loss of previously acquired developmental milestones, progressive loss of motor function, spasticity, and cognitive decline. Without treatment, children become severely disabled by age 3-4 years and die in early childhood. Late-infantile forms progress similarly but with a slightly later onset. Juvenile forms progress more slowly over years to decades. Adult-onset forms may present with psychiatric symptoms, cognitive decline, or progressive motor symptoms and can remain relatively stable for extended periods. MRI shows progressive white matter demyelination and atrophy. Urine analysis may show elevated sulfatides. The first FDA-approved treatment for MLD, the gene therapy Lenmeldy (atidarsagene autotemcel), was approved in March 2024. Donor stem cell transplant has been used mainly for early juvenile MLD, though the FDA's review of Lenmeldy noted it is not considered standard of care.

Common Symptoms of Metachromatic Leukodystrophy

Recognizing the signs of Metachromatic Leukodystrophy early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Infantile form: loss of developmental milestones starting 6-24 months
  • Progressive loss of motor function and muscle tone
  • Loss of vision and hearing
  • Behavioral and cognitive decline
  • Seizures and spasticity
  • Inability to walk or stand in later stages

Who Metachromatic Leukodystrophy Affects

Infantile-onset form (most common, 50% of cases) presents before age 2 years. Late-infantile form presents between 2-4 years. Juvenile form presents between 4 years and adolescence. Adult form (rare) presents after age 16 with slower progression. Autosomal recessive inheritance. Affects males and females equally. Occurs across all populations.

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FDA-Approved Treatments for Metachromatic Leukodystrophy

There is currently 1 FDA-approved medication for Metachromatic Leukodystrophy. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials.

atidarsagene autotemcel
Orchard Therapeutics (a Kyowa Kirin company)
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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Help Paying for Metachromatic Leukodystrophy Treatment

Charity funds and drugmaker programs for Metachromatic Leukodystrophy, checked at the source. Pick your insurance to see what fits.

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Charity funds
  • From a charity · United Leukodystrophy Foundation
    Hultman Memorial Fund fund
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    Pays for: Expenses directly related to the affected family member, based on demonstrated hardship (per 12 months), up to $500 per year.

    The foundation says: “Applications are reviewed on a rolling basis as funding is available.”
Status as each foundation showed it on September 28, 2026.
Drugmaker programs
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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Genetic Testing

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Metachromatic Leukodystrophy Resources

Reputable organizations and medical references for learning more about Metachromatic Leukodystrophy, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Metachromatic Leukodystrophy

Use this Metachromatic Leukodystrophy clinical trial finder to see the 7 studies recruiting patients and 2 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for metabolic & lysosomal conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

9 active trials worldwide
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RECRUITINGPHASE1Recently updatedNCT02254863

UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells

Intervention: DUOC-01

Sponsor: Joanne Kurtzberg, MD

The primary objective of the study is to determine the safety and feasibility of intrathecal administration of DUOC-01 in patients who are undergoing standard treatment with umbilical cord blood transplant (UCBT) for inborn errors of metabolism and who have evidence of early demy...

Ages 1 Week – 22 Years1 location
Started Sep 2014Updated 3 weeks agoEst. Oct 2027 (~1y 1m)
NOT YET RECRUITINGNARecently updatedNCT07046338

Lentiviral Hematopoietic Stem Cell Gene Therapy for MLD

Intervention: Lentiviral TYF-ARSA correction of patient's autologous HSCs

Sponsor: Shenzhen Geno-Immune Medical Institute

This is a Phase I/II clinical trial of gene therapy for treating Metachromatic leukodystrophy (MLD) using a safety and efficacy improved self-inactivating lentiviral vector TYF-ARSA to transduce patient-derived hematopoietic stem cells (HSCs), with the goal of achieving therapeut...

Ages 1 Month – 50 Years1 location
Started Jun 2027Updated 4 weeks agoEst. May 2028 (~1y 8m)
NOT YET RECRUITINGNARecently updatedNCT03725670

Direct Lentiviral Injection Gene Therapy for MLD

Intervention: Intrathecal and intravenous LV gene therapy

Sponsor: Shenzhen Geno-Immune Medical Institute

This is a Phase I/II clinical trial of gene therapy for treating Metachromatic leukodystrophy (MLD) using a safety and efficacy improved self-inactivating lentiviral vector TYF-ARSA to functionally correct the genetic defect. The primary objectives are to evaluate the safety and ...

Ages 1 Month – 50 Years1 location
Started May 2027Updated 4 weeks agoEst. Jun 2028 (~1y 8m)
RECRUITINGNo updates in a whileNCT04528355

Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC

Intervention: data collection

Sponsor: Paul Szabolcs

This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft failure and to aid in immune reconstitution follow...

Ages 2 Months – 60 Years1 location
Started Aug 2020Updated 8 months agoEst. Dec 2027 (~1y 3m)
RECRUITINGPHASE2No updates in a whileNCT01962415

Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT

Intervention: Hydroxyurea, Alemtuzumab, Fludarabine, Melphalan, Thiotepa

Sponsor: Paul Szabolcs

The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) ...

Ages 2 Months – 55 Years1 location
Started Feb 2014Updated 9 months agoEst. Nov 2026 (~2 months)
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Active trial locations23 cities in the US
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Patient Communities

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Related Metabolic & Lysosomal Conditions

Other rare diseases in the metabolic & lysosomal category. Patients with Metachromatic Leukodystrophy may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Metachromatic Leukodystrophy Treatments

2 pharmaceutical companies have Metachromatic Leukodystrophy in their rare disease portfolio

Frequently Asked Questions About Metachromatic Leukodystrophy