Idursulfase beta
As of the edition of 20 October 2026, Idursulfase beta is an enzyme: marketed, first approved in 2021 (JP).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Enzyme
- First approved
- 22 January 2021 (JP)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Clinigen
- Registered trials
- 3, 0 stopped early
- Disease areas
- Inherited and neonatal; Nervous system; Nutrition and metabolism; Skin and connective tissue
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Clinigen | Originator | 2021 to now |