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glucosidase alfa
glucosidase alfa is a Small molecule drug developed by LMU Klinikum. It is currently in Phase 2 development. Also known as: Myozyme.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | glucosidase alfa |
|---|---|
| Also known as | Myozyme |
| Sponsor | LMU Klinikum |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Developing a Management Approach for Patients With "Late-Onset" Pompe Disease
- Drug-drug Interaction Study (PHASE2)
- A Study of Velaglucerase Alfa (VPRIV) in Chinese Children, Teenagers, and Adults With Type 1 Gaucher Disease (PHASE3)
- Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- Long Term Impact of Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) (PHASE4)
- Immune Tolerance Induction Study (PHASE4)
- Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease (PHASE4)
- A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher Disease (PHASE3)
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:
- glucosidase alfa CI brief — competitive landscape report
- glucosidase alfa updates RSS · CI watch RSS
- LMU Klinikum portfolio CI
Frequently asked questions about glucosidase alfa
What is glucosidase alfa?
Who makes glucosidase alfa?
Is glucosidase alfa also known as anything else?
What development phase is glucosidase alfa in?
Related
- Manufacturer: LMU Klinikum — full pipeline
- Also known as: Myozyme
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing