Glycogen storage disease due to acid maltase deficiency

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ORPHA:365OMIM:232300E74.0
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4FDA treatments26Active trials29Specialists8Treatment centers1Financial resources

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Glycogen storage disease due to acid maltase deficiency, also known as Pompe disease or glycogen storage disease type II (GSD II), is a rare inherited metabolic disorder caused by mutations in the GAA gene, which encodes the lysosomal enzyme acid alpha-glucosidase (acid maltase). This enzyme is responsible for breaking down glycogen within lysosomes. When the enzyme is deficient or absent, glycogen accumulates progressively in cells throughout the body, particularly in skeletal muscle, cardiac muscle, and smooth muscle, leading to cellular damage and organ dysfunction. Pompe disease presents as a clinical spectrum ranging from a severe infantile-onset form to milder late-onset forms. The classic infantile form typically manifests within the first few months of life with profound hypotonia (floppy baby), severe hypertrophic cardiomyopathy, feeding difficulties, respiratory distress, failure to thrive, and hepatomegaly. Without treatment, infantile-onset Pompe disease is usually fatal within the first year of life due to cardiorespiratory failure. The late-onset form (childhood, juvenile, or adult onset) is characterized by progressive proximal muscle weakness, particularly affecting the limb-girdle and respiratory muscles, without significant cardiac involvement. Patients often develop respiratory insufficiency, which may be the presenting symptom, along with difficulty walking, climbing stairs, and performing daily activities. The primary treatment for Pompe disease is enzyme replacement therapy (ERT) with recombinant human acid alpha-glucosidase (alglucosidase alfa, marketed as Myozyme/Lumizyme, and the next-generation avalglucosidase alfa, marketed as Nexviazyme). ERT has significantly improved survival and cardiac outcomes in infantile-onset patients and has been shown to stabilize or slow disease progression in late-onset patients. Supportive care includes respiratory support (including ventilatory assistance), physical therapy, occupational therapy, nutritional management, and regular monitoring of cardiac and pulmonary function. Gene therapy approaches are currently under investigation in clinical trials.

Also known as:

Clinical phenotype terms— hover any for plain English:

Abnormal internal carotid artery morphologyHP:3000062Motor axonal neuropathyHP:0007002AtelectasisHP:0100750Progressive proximal muscle weaknessHP:0009073OligosacchariduriaHP:0010471Decreased circulating acid maltase activityHP:0034932Tongue fasciculationsHP:0001308
Inheritance

Autosomal recessive

Passed on when both parents carry the same gene change; often skips generations

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026BERKLEY AND JENSEN OMEPRAZOLE: New indication approved
FDAcompleted
Mar 2026Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease

University of Missouri-Columbia — NA

TrialRECRUITING
Mar 2026A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease

Denali Therapeutics Inc. — PHASE1

TrialNOT YET RECRUITING
Feb 2026A Study to Evaluate Safety, Tolerability, and Efficacy of AB-1009 Gene Therapy (GAA Gene) in Adult Participants With Late Onset Pompe Disease (PROGRESS-GT LOPD)

AskBio Inc — PHASE1, PHASE2

TrialRECRUITING
Oct 2025Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)

Shionogi — PHASE2

TrialRECRUITING
May 2025China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD

Genzyme, a Sanofi Company — PHASE4

TrialRECRUITING
Dec 2024Rare Glycogen Storage Diseases Natural History Study

Duke University

TrialRECRUITING
Nov 2024A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD

Oculox Technologies SA — NA

TrialRECRUITING
Oct 2024Treatment Frequency Reduction in Pompe Disease

Erasmus Medical Center — PHASE4

TrialNOT YET RECRUITING
Apr 2024Evaluation of the Safety and Efficacy of Late-onset Pompe Disease Gene Therapy Drug

GeneCradle Inc — PHASE1, PHASE2

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

4 available

Omeprazole

OMEPRAZOLE· PD-Rx Pharmaceuticals, Inc.

Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older

Pombiliti and Opfolda

cipaglucosidase alfa-atga and miglustat· Amicus Therapeutics, Inc.Orphan Drug
in combination with Pombiliti, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing greater than or equal to 40 kg and who are

in combination with Pombiliti, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing greater than or equal to 40 kg and who are not improving on their current enzyme replacement therapy (ERT)

Nexviazyme

AVALGLUCOSIDASE ALFA-NGPT· Genzyme Corporation■ Boxed WarningOrphan Drug

Treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency)

Myozyme

Recombinant human acid alpha-glucosidase; alglucosidase alfa· Genzyme CorporationOrphan Drug
Myozyme for use in patients with Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve ventilator-free survival in patients with infantile onset Pompe disease as compared to an

Myozyme for use in patients with Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve ventilator-free survival in patients with infantile onset Pompe disease as compared to an untreated historical control, whereas use of Alphaglucosidase in patients with other forms of Pompe disease has not been adequately studied to assure safety and efficacy.

Clinical Trials

20 recruitingView all trials with filters →
Phase 33 trials
A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18
Phase 3
Actively Recruiting
· Sites: Gainesville, Florida; Atlanta, Georgia +12 more · Age: 017 yrs
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD
Phase 3
Active
· Sites: Gainesville, Florida; Jacksonville, Florida +15 more · Age: 017 yrs
Clinical Study for Treatment-naïve IOPD Babies to Evaluate Efficacy and Safety of ERT With Avalglucosidase Alfa
Phase 3
Active
PI: Clinical Sciences & Operations (Sanofi) · Sites: Stanford, California; Minneapolis, Minnesota +14 more
Phase 42 trials
China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD
Phase 4
Actively Recruiting
PI: Trial Transparency email recommended (Toll free for US & Canada) · Sites: Shanghai · Age: 017 yrs
Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)
Phase 4
Active
PI: Clinical Sciences & Operations (Sanofi) · Sites: Bordeaux; Brest +9 more · Age: 699 yrs
Phase 22 trials
Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)
Phase 2
Actively Recruiting
· Sites: Irvine, California; Gainesville, Florida +26 more · Age: 1899 yrs
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
Phase 2
Active
PI: Clinical Sciences & Operations (Sanofi) · Sites: Valhalla, New York; Durham, North Carolina +10 more · Age: 017 yrs
Other10 trials
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
Actively Recruiting
PI: Priya S Kishnani, MD (Duke University) · Sites: Durham, North Carolina
Novel Metabolic Muscular Biomarkers in Pompe Disease - a Non-invasive Magnetic Resonance Exploratory Pilot Study.
Active
· Sites: Vienna, Vienna · Age: 1870 yrs
A Prospective Study to Observe & Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age With Infantile-onset Pompe Disease (IOPD)
Active
PI: Clinical Sciences & Operations (Sanofi) · Sites: Hawthorne, New York; Durham, North Carolina +13 more
Cognitive and Neurological Pathologies in Pompe Disease
Actively Recruiting
PI: Priya Kishnani, MD (Duke University) · Sites: Durham, North Carolina · Age: 018 yrs
Rare Glycogen Storage Diseases Natural History Study
Actively Recruiting
PI: Priya Kishnani, M.D. (Duke) · Sites: Durham, North Carolina · Age: 090 yrs
A Global Prospective Observational Registry of Patients With Pompe Disease
Actively Recruiting
· Sites: Little Rock, Arkansas; Irvine, California +39 more
Developing a Management Approach for Patients With "Late-Onset" Pompe Disease
Active
PI: Priya Kishnani, MD (Duke University) · Sites: Durham, North Carolina
Natural History of Pompe Disease
Actively Recruiting
PI: Helge Amthor, MD, PhD (Hôpital Raymond Poincaré) · Sites: Garches, Hauts-de-Seine · Age: 1880 yrs
A Long-term Study for the Outcome of Pompe Disease
Actively Recruiting
PI: Yin-Hsiu Chien (National Taiwan University Hospital) · Sites: Taipei
Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases
Active
· Sites: Copenhagen, Copenhange · Age: 1899 yrs

Specialists

Showing 25 of 29View all specialists →
YP
Yin-Hsiu Chien, MD, PhD
Specialist
PI on 2 active trials
TM
Tahseen Mozaffar, MD
ORANGE, CA
Specialist
PI on 3 active trials
JM
Joseph Rossano, MD
PHILADELPHIA, PA
Specialist
PI on 2 active trials
WP
Whu-Liang Hwu, MD, PhD
Specialist
PI on 3 active trials
OM
Ozlem Goker-Alpan, MD
Fairfax, Virginia
Specialist

Rare Disease Specialist

PI on 9 active trials
UC
Use Central Contact
Specialist
PI on 28 active trials
BP
Barry J Byrne, MD, PhD
GAINESVILLE, FL
Specialist
PI on 3 active trials
MP
Manuela Corti, PT, PhD
Specialist
PI on 2 active trials
BP
Barbara K Smith, PT, PhD
Specialist
PI on 3 active trials
HM
Hal Landy, MD
DOVER, MA
Specialist
PI on 5 active trials
KM
Karen L Madsen, MD
MILWAUKEE, WI
Specialist
PI on 3 active trials
IK
Irina Kline
WYOMISSING, PA
Specialist
PI on 1 active trial
PB
Paolo Banfi
Specialist
PI on 1 active trial
PD
Pieter A. van Doorn
Specialist
PI on 1 active trial
DK
Dwight D Koeberl
DURHAM, NC
Specialist
PI on 3 active trials
GY
Guang Yang
Specialist
PI on 1 active trial
DK
Dwight Koeberl
DURHAM, NC
Specialist
PI on 2 active trials
AS
Alfred E Slonim
Specialist
PI on 1 active trial
MP
Michael Przybylski
Specialist
PI on 1 active trial
SG
Serhat Gumrukcu
Specialist
PI on 1 active trial

Treatment Centers

8 centers
⚗️ Trial Site

UC Davis MIND Institute- Site Number : 840010

📍 Sacramento, California

⚗️ Trial Site

University of California at Irvine- Site Number : 840036

📍 Irvine, California

⚗️ Trial Site

University of Arizona- Site Number : 840015

📍 Tucson, Arizona

⚗️ Trial Site

Southern California Permanente Medical Group- Site Number : 840108

📍 Los Angeles, California

⚗️ Trial Site

University of California at San Diego- Site Number : 840007

📍 San Diego, California

⚗️ Trial Site

University of Arkansas for Medical Sciences- Site Number : 840113

📍 Little Rock, Arkansas

⚗️ Trial Site

Phoenix Children's Hospital- Site Number : 840003

📍 Phoenix, Arizona

⚗️ Trial Site

USC Health Sciences Center Dept of Genetics- Site Number : 840082

📍 Los Angeles, California

Financial Resources

1 resources
Pombiliti and Opfolda(cipaglucosidase alfa-atga and miglustat)Amicus Therapeutics, Inc.

Travel Grants

No travel grants are currently matched to Glycogen storage disease due to acid maltase deficiency.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Glycogen storage disease due to acid maltase deficiency

4 articles
AdvocacyRSSApr 22, 2026
Riding the Absa Cape Epic With Pompe Disease: The Decision to Take on the Impossible
Bruce Campbell, who has Pompe disease, is competing in the Absa Cape Epic, one of the world's toughest mountain biking races. Despite living with a rare muscle
NewsRSSApr 22, 2026
At 12, I Couldn’t Gain Weight With Pompe Disease, but at 35, I Struggle to Lose It
A person with Pompe disease shares how their weight challenges changed over time. As a child, they couldn't gain weight and stayed at 60 pounds. Now as an adult
ResearchPUBMEDApr 3, 2026
Artificial Intelligence, Connected Care, and Enabling Digital Health Technologies in Rare Diseases With a Focus on Lysosomal Storage Disorders: Scoping Review.
Researchers reviewed studies from the past 10 years about how artificial intelligence and connected care technologies can help patients with rare diseases, espe
NewsUNITERAREApr 3, 2026
Fund Update: PAN Foundation — Pompe disease Fund Pompe disease fund is currently closed
The PAN Foundation's financial assistance program for Pompe disease patients is currently closed and not accepting new applications. This program previously pro
See all news about Glycogen storage disease due to acid maltase deficiency

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Glycogen storage disease due to acid maltase deficiency

What is Glycogen storage disease due to acid maltase deficiency?

Glycogen storage disease due to acid maltase deficiency, also known as Pompe disease or glycogen storage disease type II (GSD II), is a rare inherited metabolic disorder caused by mutations in the GAA gene, which encodes the lysosomal enzyme acid alpha-glucosidase (acid maltase). This enzyme is responsible for breaking down glycogen within lysosomes. When the enzyme is deficient or absent, glycogen accumulates progressively in cells throughout the body, particularly in skeletal muscle, cardiac muscle, and smooth muscle, leading to cellular damage and organ dysfunction. Pompe disease presents

How is Glycogen storage disease due to acid maltase deficiency inherited?

Glycogen storage disease due to acid maltase deficiency follows a autosomal recessive inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

Are there clinical trials for Glycogen storage disease due to acid maltase deficiency?

Yes — 20 recruiting clinical trials are currently listed for Glycogen storage disease due to acid maltase deficiency on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Glycogen storage disease due to acid maltase deficiency?

25 specialists and care centers treating Glycogen storage disease due to acid maltase deficiency are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Glycogen storage disease due to acid maltase deficiency?

2 patient support programs are currently tracked on UniteRare for Glycogen storage disease due to acid maltase deficiency. See the treatments and support programs sections for copay assistance, eligibility, and contact details.