Friday, July 10, 2026

Drug profile · INN

migalastat hydrochloride

migalastat hydrochloride (GALAFOLD) is a alpha-galactosidase a stabiliser. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 1
Drug details — migalastat hydrochloride

Quick answer

migalastat hydrochloride (GALAFOLD) is a alpha-galactosidase a stabiliser. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN migalastat hydrochloride
Brand GALAFOLD
Mechanism Alpha-galactosidase A stabiliser
Target Alpha-galactosidase A
Route ORAL
Formulation CAPSULE

Mechanism of action

Alpha-galactosidase A stabiliser

Primary target: Alpha-galactosidase A

Approval history

Authority Status Date
FDA approved
PMDA approved

Recent coverage

Pipeline programs

  1. Migalastat Hydrochloride Dispersible Tablet Phase 3 · Pacalis Therapeutics Pty · Fabry disease

Related & competitor drugs

  1. migalastat Alimentary tract and metabolism (A16)

Frequently asked questions

What is migalastat hydrochloride?

migalastat hydrochloride (GALAFOLD) is a alpha-galactosidase a stabiliser. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for migalastat hydrochloride?

GALAFOLD is a marketed brand name for migalastat hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of migalastat hydrochloride?

migalastat hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.