GALAFOLD

Peak

migalastat hydrochloride

NDAORALCAPSULEPriority Review
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9

Mechanism of Action

alpha-galactosidase A (alpha-Gal A) protein (encoded by the galactosidase alpha gene, GLA ), which is deficient in Fabry disease. This binding stabilizes alpha-Gal A allowing its trafficking from the endoplasmic reticulum into the lysosome where it exerts its action. In the lysosome, at a lower pH…

Clinical Trials (5)

NCT02082327Phase 1Completed

A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers

Started Mar 2014
NCT01730482Phase 1Completed

A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)

Started Aug 2011
NCT01196871Phase 2Completed

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

Started Feb 2011
NCT00925301Phase 3Completed

Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease

Started Oct 2009
NCT00526071Phase 2Terminated

Open-label Long-term Safety Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease Who Have Completed a Previous AT1001 Study

Started Sep 2007

Loss of Exclusivity

LOE Date
Jan 11, 2042
193 months away
Patent Expiry
Jan 11, 2042

Patent Records (5)

Patent #ExpiryTypeUse Code
9000011
May 16, 2027
U-2371
9480682
May 16, 2027
U-2371
11241422
May 16, 2027
U-2371
10406143
May 16, 2027
U-2371
10383864
May 16, 2027
U-2371