Last reviewed · How we verify
Replagal (AGALSIDASE ALFA)
Replagal (agalsidase alfa) is a marketed enzyme replacement therapy for Fabry's disease, competing in a class with other enzyme replacements such as alglucerase, imiglucerase, agalsidase beta, laronidase, and sacrosidase. Its key strength lies in its mechanism of action, which directly addresses the deficiency of alpha-Gal A enzyme, a critical factor in managing Fabry's disease. The primary risk to Replagal is the expiration of its key composition patent in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | AGALSIDASE ALFA |
|---|---|
| Modality | Enzyme |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
- Fabry's disease
Common side effects
Key clinical trials
- Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease (PHASE3)
- A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease (PHASE2,PHASE3)
- Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease (PHASE2,PHASE3)
- Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome (NA)
- A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease (PHASE3)
- Fabry Disease Registry & Pregnancy Sub-registry
- Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
- Switch Over Study of Biosimilar Agalsidase Beta for Fabry 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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Replagal CI brief — competitive landscape report
- Replagal updates RSS · CI watch RSS