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Metabolic & Lysosomal

Sanfilippo Syndrome Clinical Trials and Treatments

Also called MPS III, Mucopolysaccharidosis Type III, Mucopolysaccharidosis III, Sanfilippo Disease, MPS IIIA, Sanfilippo Syndrome Type A, MPS IIIB, Sanfilippo Syndrome Type B

Sanfilippo syndrome is the name families and clinicians use for mucopolysaccharidosis type III. It comes in four subtypes, A through D, each caused by the loss of a different enzyme in the chain that breaks down heparan sulfate: heparan sulfamidase in type A, alpha-N-acetylglucosaminidase in type B, acetyl-CoA alpha-glucosaminide N-acetyltransferase in type C, and N-acetylglucosamine-6-sulfatase in type D.

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About Sanfilippo Syndrome

Sanfilippo syndrome is the name families and clinicians use for mucopolysaccharidosis type III. It comes in four subtypes, A through D, each caused by the loss of a different enzyme in the chain that breaks down heparan sulfate: heparan sulfamidase in type A, alpha-N-acetylglucosaminidase in type B, acetyl-CoA alpha-glucosaminide N-acetyltransferase in type C, and N-acetylglucosamine-6-sulfatase in type D. Whichever enzyme is missing, the result is the same: heparan sulfate accumulates inside cells, above all in the brain, where partially broken-down fragments are toxic to nerve cells and set off inflammation and cell death.

What makes Sanfilippo different from the other MPS disorders is where it strikes. The physical signs that mark Hurler or Hunter syndrome are mild here, limited to slightly coarse features, an enlarged liver and spleen, and some skeletal changes. The brain takes the full weight of the disease. Children appear healthy at birth and through infancy, and the first signs, usually between ages 2 and 6, look like a behavioral or developmental problem: hyperactivity, a plateau in development, delayed speech. What follows is a relentless childhood dementia. Words already learned disappear, skills already mastered unwind, and behavior deteriorates into severe intellectual disability. Movement goes next, with loss of coordination, an unsteady gait and eventually the inability to walk. Sleep disturbance is common and severe, particularly in type A, and seizures develop in about 3 of every 4 children in the later stages. Type A progresses fastest and type C somewhat slower, but every form leads to profound disability.

Common Symptoms of Sanfilippo Syndrome

Recognizing the signs of Sanfilippo Syndrome 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.

  • Behavioral problems and psychiatric symptoms starting in childhood
  • Progressive intellectual disability and cognitive decline
  • Loss of speech and language abilities
  • Progressive motor deterioration and movement disorders
  • Sleep disturbances and hyperactivity
  • Seizures in later stages

Who Sanfilippo Syndrome Affects

Sanfilippo syndrome typically shows itself between ages 2 and 6, usually as behavioral change or a stall in development, with progressive neurological decline following. There are 4 genetic subtypes, A through D, with different rates of progression; type A is the most common and the fastest. It affects boys and girls equally and is inherited in an autosomal recessive pattern, meaning both parents carry a copy without symptoms. It is most frequent in Scandinavian and Aboriginal Australian populations.

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FDA-Approved Treatments for Sanfilippo Syndrome

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

rebisufligene etisparvovec
Ultragenyx
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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 Sanfilippo Syndrome Treatment

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

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Charity funds
  • From a charity · TotalAssist (formerly PAN Foundation)
    Mucopolysaccharidosis Type III (Sanfilippo) fund
    Open

    Pays for: Out-of-pocket costs for approved medications, up to $2,500 per year. Requires health insurance (any kind).

  • From a charity · National MPS Society
    Family Assistance Program fund
    Apply directly

    Pays for: Specialized equipment and medical aids not covered by insurance (requires insurance denial and 10% family copay), up to $3,000 per year.

    The foundation says: “Status not shown on page”
  • From a charity · National MPS Society
    Medical Travel Assistance Program fund
    Apply directly

    Pays for: Travel to out-of-town medical appointments more than 125 miles away (per year), up to $550 per year.

    The foundation says: “Status not shown on page”
  • From a charity · National MPS Society
    Journey Assistance Program fund
    Apply directly

    Pays for: Items that ease daily life (40% of purchase price), up to $500 per year.

    The foundation says: “Status not shown on page”
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 Sanfilippo Syndrome Resources

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

Active Clinical Trials for Sanfilippo Syndrome

Use this Sanfilippo Syndrome clinical trial finder to see the 8 studies recruiting patients and 3 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.

11 active trials worldwide
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RECRUITINGPHASE2, PHASE3Recently updatedNCT02716246

Phase I/II/III Gene Transfer Clinical Trial of scAAV9.U1a.hSGSH

Intervention: UX111, Prophylactic Immunomodulatory (IM) Therapy, Optimized Prophylactic IM Therapy, Adjuvant IM Therapy

Sponsor: Ultragenyx Pharmaceutical Inc · Abeona Therapeutics, Inc

The main objective of this study is to evaluate the efficacy and safety of UX111 for the treatment of MPS IIIA.

Ages not specified5 locations
Started Apr 2016Updated 1 week agoEst. Mar 2029 (~2y 6m)
NOT YET RECRUITINGPHASE3Recently updatedNCT07579910

Intracerebroventricular Tralesinidase Alfa in Participants With MPS IIIB (Sanfilippo Syndrome Type B)

Intervention: Tralesinidase alfa (TA)

Sponsor: Spruce Biosciences

The primary objectives of this study are to evaluate the effects of Tralesinidase Alfa (TA) on cognition

Ages 1 Year – 5 Years
Started Dec 2026Updated 1 week agoEst. Aug 2033 (~6y 11m)
RECRUITINGPHASE2, PHASE3Recently updatedNCT06333041

Study of Cannabidiol in Sanfilippo Syndrome

Intervention: Epidiolex, Placebo

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.

Ages 4 Years+1 location
Started Apr 2026Updated 2 weeks agoEst. Apr 2027 (~7 months)
NOT YET RECRUITINGPHASE1, PHASE2Recently updatedNCT07818759

Single Injection of rAAV9-CMV-hNAGLUop Gene for Patients With Mucopolysaccharidosis (MPS) IIIB

Intervention: rAAV9-CMV-hNAGLUop

Sponsor: NeuroGT

The goal of this clinical trial is to learn if one infusion of rAAV9-CMV-hNAGLUop can treat patients with Sanfilippo syndrome (MPS III) 6 months or older. The main questions it aims to answer are:

* Is the treatment safe?

* Is there a change in enzyme activities,?

Ages 6 Months+1 location
Started Jan 2027Updated 2 weeks agoEst. Dec 2028 (~2y 3m)
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)
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Active trial locations7 cities in the US

Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Patient Communities

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Related Metabolic & Lysosomal Conditions

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

Sanfilippo Syndrome News and Analysis

Trial Friend articles about Sanfilippo Syndrome, newest first

Companies Developing Sanfilippo Syndrome Treatments

6 pharmaceutical companies have Sanfilippo Syndrome in their rare disease portfolio

Frequently Asked Questions About Sanfilippo Syndrome