Alglucosidase Alfa
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Also known as .alpha.-glucosidaseAcid .alpha.-glucosidaseAcid alpha glucosidaseAlglucosidasa alfaAlglucosidaseAlpha-glucopyranosidaseAlpha-glucosidaseGlucosidasealpha-GZ419829LumizymeMyozymeNdi 709RHGAATransglucosidase
Summary
Alglucosidase Alfa (CHEMBL1201824) is an approved enzyme (ATC A16AB07); indicated across 3 conditions including disorder of glycogen metabolism.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Enzyme
- ATC class: A16AB07
- Indications: 3 conditions
- Clinical trials: 37
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201824 |
| Name | Alglucosidase Alfa |
| Type | Enzyme |
| Max phase | 4 |
| ATC | A16AB07 |
Also known as: .alpha.-glucosidase, Acid .alpha.-glucosidase, Acid alpha glucosidase, Alglucosidasa alfa, Alglucosidase, Alglucosidase alfa, Alpha-glucopyranosidase, Alpha-glucosidase, Glucosidase, alpha-, GZ419829, Lumizyme
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
3 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| disorder of glycogen metabolism | 3 | MONDO:0002412 | MONDO:0002412 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 37.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 12 |
| Not specified | 9 |
| PHASE3 | 6 |
| PHASE2 | 6 |
| PHASE2/PHASE3 | 2 |
| PHASE1/PHASE2 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06449235 | PHASE4 | NOT_YET_RECRUITING | Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh |
| NCT00455195 | PHASE4 | COMPLETED | Late-Onset Treatment Study Extension Protocol |
| NCT00483379 | PHASE4 | COMPLETED | High Dose or High Dose Frequency Study of Alglucosidase Alfa |
| NCT00486889 | PHASE4 | COMPLETED | Growth and Development Study of Alglucosidase Alfa |
| NCT00701129 | PHASE4 | COMPLETED | An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease |
| NCT01288027 | PHASE4 | COMPLETED | Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa |
| NCT01410890 | PHASE4 | COMPLETED | Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease |
| NCT01526785 | PHASE4 | TERMINATED | A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease |
| NCT01597596 | PHASE4 | TERMINATED | A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease |
| NCT02730377 | PHASE4 | COMPLETED | Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes |
| NCT02954692 | PHASE4 | COMPLETED | A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey |
| NCT04676373 | PHASE4 | COMPLETED | Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen |
| NCT00059280 | PHASE2/PHASE3 | COMPLETED | A Study of the Safety and Efficacy of rhGAA in Patients With Infantile-onset Pompe Disease |
| NCT00125879 | PHASE2/PHASE3 | COMPLETED | Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602 |
| NCT00158600 | PHASE3 | COMPLETED | A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease |
| NCT00268944 | PHASE3 | COMPLETED | Safety and Effectiveness Study of rhGAA in Patients With Advanced Late-Onset Pompe Disease Receiving Respiratory Support |
| NCT01301833 | PHASE3 | COMPLETED | Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes |
| NCT01777282 | PHASE3 | COMPLETED | A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus |
| NCT02782741 | PHASE3 | COMPLETED | Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease |
| NCT03729362 | PHASE3 | COMPLETED | A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease |
| NCT03019406 | PHASE2 | ACTIVE_NOT_RECRUITING | 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 |
| NCT00051935 | PHASE2 | COMPLETED | A Study of the Safety and Pharmacokinetics of rhGAA in Siblings With Glycogen Storage Disease Type II |
| NCT00053573 | PHASE1/PHASE2 | COMPLETED | rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe Disease) |
| NCT00250939 | PHASE2 | COMPLETED | A Study of rhGAA in Patients With Late-Onset Pompe Disease |
| NCT00763932 | PHASE2 | COMPLETED | Extension Study of Long-term Safety and Efficacy of Myozyme in Patients With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored Enzyme Replacement Therapy (ERT) Studies |
| NCT00765414 | PHASE2 | COMPLETED | Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies. |
| NCT01380743 | PHASE2 | COMPLETED | Drug-drug Interaction Study |
| NCT02898753 | PHASE1/PHASE2 | TERMINATED | VAL-1221 Delivered Intravenously in Ambulatory and Ventilator-free Participants With Late-Onset Pompe Disease |
| NCT04848779 | Not specified | ACTIVE_NOT_RECRUITING | A Prospective Study to Observe & Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age With Infantile-onset Pompe Disease (IOPD) |
| NCT05017402 | Not specified | NOT_YET_RECRUITING | Higher Dose of Alglucosidase Alpha for Pompe Disease |
| NCT00074919 | Not specified | APPROVED_FOR_MARKETING | Expanded Access Use of Myozyme (Alglucosidase Alfa) in Patients With Infantile-onset Pompe Disease |
| NCT00074932 | Not specified | COMPLETED | Expanded Access Use of Myozyme (Alglucosidase Alfa) in Patients With Late-onset Pompe Disease |
| NCT00566878 | Not specified | COMPLETED | Pompe Lactation Sub-Registry |
| NCT01710813 | Not specified | COMPLETED | Alglucosidase Alfa Pompe Safety Sub-Registry |
| NCT02456428 | Not specified | COMPLETED | Incretin-based Drugs and the Risk of Heart Failure |
| NCT02475499 | Not specified | COMPLETED | Incretin-based Drugs and Pancreatic Cancer |
| NCT02476760 | Not specified | COMPLETED | Incretin-based Drugs and Acute Pancreatitis |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: disorder of glycogen metabolism