Galafold

(Migalastat)

Small molecule

AAmicus Therapeutics

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

Fabry Disease

NCT05280548

Q1 2030

Recruiting

Fabry Disease

NCT04252066

Clinical

Trials by Indication[1]

Fabry Disease3 trials

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Recruiting·AAmicus Therapeutics··NCT04252066·20 enrolled

A Study of Migalastat in Fabry Disease

Unknown status·MManchester University NHS Foundation Trust··NCT03949920·21 enrolled

A Randomized, Open-label, Parallel-group, 18-month Phase 3 Study to Evaluate the Effect of Venglustat Compared With Usual Standard of Care on Left Ventricular Mass Index in Participants With Fabry Disease and Left Ventricular Hypertrophy

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05280548·104 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 10, 2018

GALAFOLD

NDA NDA208623

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Migalastat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Migalastat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208623). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Galafold. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Amicus Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAmicus Therapeutics

Patent Landscape[4]

Patent Cliff

May 16, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9480682May 16, 2027

10383864May 16, 2027

11241422May 16, 2027

9000011May 16, 2027

10406143May 16, 2027

61 more patents

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