Migalastat
As of the edition of 20 October 2026, Migalastat is a small molecule: marketed, first approved in 2016 (EU); acts on GLA; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Galafold
- First approved
- 25 May 2016 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Amicus Therapeutics; 3 holders in all
- Registered trials
- 21, 2 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Nervous system; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by Amicus Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product16 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Migalastat.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GLA | Alpha-galactosidase A | P06280 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 2 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 6 | 5 | 0 | 1 |
| Phase 3 | 8 | 5 | 2 | 1 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amicus Therapeutics | Applicant and Lead sponsor of trials | 2011 to now |