Cipaglucosidase alfa
As of the edition of 20 October 2026, Cipaglucosidase alfa is an enzyme: marketed, first approved in 2023 (EU); acts on IGF2R; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Enzyme
- Brand name
- Pombiliti
- First approved
- 20 March 2023 (EU)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Amicus Therapeutics; 3 holders in all
- Registered trials
- 8, 0 stopped early
- Disease areas
- Inherited and neonatal; Nervous system; Nutrition and metabolism
US protection
US protection ends in 2035.
US protection ends in 2035, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Amicus Therapeutics. The date is computed, not published.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
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 Cipaglucosidase alfa.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IGF2R | Cation-independent mannose-6-phosphate receptor | P11717 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 1 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 4 | 2 | 2 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amicus Therapeutics | Applicant and Lead sponsor of trials | 2023 to now |