Last reviewed 2026-05-31 · How we verify

Naglazyme®

Masonic Cancer Center, University of Minnesota · FDA-approved active Small molecule Under review Quality 0/100

Naglazyme® is a Enzyme replacement therapy Small molecule drug developed by Masonic Cancer Center, University of Minnesota. It is currently FDA-approved for Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). Also known as: recombinant human N-acetylgalactosamine 4-sulfatase, rh-arylsulfatase B, rhASB.

Naglazyme is a recombinant human arylsulfatase B enzyme that breaks down glycosaminoglycans accumulated in mucopolysaccharidosis VI (MPS VI).

Naglazyme is a hydrolytic enzyme used to treat Maroteaux-Lamy Syndrome, a condition caused by a deficiency in the enzyme that breaks down dermatan sulfate. It works by hydrolyzing dermatan sulfate, a type of glycosaminoglycan that accumulates in the bodies of individuals with Maroteaux-Lamy Syndrome.

At a glance

Generic name	Naglazyme®
Also known as	recombinant human N-acetylgalactosamine 4-sulfatase, rh-arylsulfatase B, rhASB
Sponsor	Masonic Cancer Center, University of Minnesota
Drug class	Enzyme replacement therapy
Target	Arylsulfatase B (ARSB)
Modality	Small molecule
Therapeutic area	Rare genetic disease / Lysosomal storage disorder
Phase	FDA-approved

Mechanism of action

Naglazyme replaces the deficient or absent arylsulfatase B enzyme in patients with MPS VI, enabling the degradation of dermatan sulfate and other glycosaminoglycans that accumulate in tissues and organs. By restoring enzymatic activity, the drug reduces pathological substrate accumulation and slows disease progression. This is an enzyme replacement therapy (ERT) approach to treating a lysosomal storage disorder.

Approved indications

Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome)

Common side effects

Infusion-related reactions
Antibody formation
Pyrexia
Headache
Chills

Key clinical trials

Naglazyme After Allo Transplant for Maroteaux-Lamy Syndrome (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Naglazyme® CI brief — competitive landscape report
Naglazyme® updates RSS · CI watch RSS
Masonic Cancer Center, University of Minnesota portfolio CI

Frequently asked questions about Naglazyme®

What is Naglazyme®?

Naglazyme® is a Enzyme replacement therapy drug developed by Masonic Cancer Center, University of Minnesota, indicated for Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).

How does Naglazyme® work?

Naglazyme is a recombinant human arylsulfatase B enzyme that breaks down glycosaminoglycans accumulated in mucopolysaccharidosis VI (MPS VI).

What is Naglazyme® used for?

Naglazyme® is indicated for Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).

Who makes Naglazyme®?

Naglazyme® is developed and marketed by Masonic Cancer Center, University of Minnesota (see full Masonic Cancer Center, University of Minnesota pipeline at /company/masonic-cancer-center-university-of-minnesota).

Is Naglazyme® also known as anything else?

Naglazyme® is also known as recombinant human N-acetylgalactosamine 4-sulfatase, rh-arylsulfatase B, rhASB.

What drug class is Naglazyme® in?

Naglazyme® belongs to the Enzyme replacement therapy class. See all Enzyme replacement therapy drugs at /class/enzyme-replacement-therapy.

What development phase is Naglazyme® in?

Naglazyme® is FDA-approved (marketed).

What are the side effects of Naglazyme®?

Common side effects of Naglazyme® include Infusion-related reactions, Antibody formation, Pyrexia, Headache, Chills.

What does Naglazyme® target?

Naglazyme® targets Arylsulfatase B (ARSB) and is a Enzyme replacement therapy.

Drug class: All Enzyme replacement therapy drugs
Target: All drugs targeting Arylsulfatase B (ARSB)
Manufacturer: Masonic Cancer Center, University of Minnesota — full pipeline
Therapeutic area: All drugs in Rare genetic disease / Lysosomal storage disorder
Indication: Drugs for Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome)
Also known as: recombinant human N-acetylgalactosamine 4-sulfatase, rh-arylsulfatase B, rhASB

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing