FDA · United States
idursulfase — FDA regulatory status
idursulfase (ELAPRASE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ELAPRASE
- Originator
- Takeda
- Mechanism
- Heparan sulfate hydrolytic enzyme
- Target
- Heparan sulfate
- Structured fields
- 7
Sponsor / originator context: Takeda. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Heparan sulfate hydrolytic enzyme. Target: Heparan sulfate. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 10 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Elaprase 2 mg/ml concentrate for solution for infusion | Phase 3 | Denali Therapeutics | 2024-510990-21-00 |
| Idursulfase (idursulfase-IT [HGT-2310]) | Phase 3 | Takeda | 2023-504127-90-00 |
| JR-141-GS31 | Phase 3 | Anaxis Pharma | 2024-512289-33-00 |
| idursulfase-IT | Phase 3 | Takeda | NCT01506141, NCT02055118 |
| Idursulfase IT (1 mg) | Phase 2 | Takeda | NCT00920647 |
| ELAPRASE | Approved | Takeda | NCT05494593 |
| Elaprase | Approved | Takeda | NCT05058391 |
| Elaprase for intravenous (IV) infusion | Approved | Takeda | NCT02455622 |
| Elaprase for intravenous (IV) infusion | Approved | Shire | NCT02455622 |
| Idursulfase | Approved | Takeda | NCT00607386, NCT00630747 |
Related hubs
FAQ
What is the FDA approval status of idursulfase?
idursulfase currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get idursulfase regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to idursulfase?
This spoke lists 10 published programs associated with idursulfase in our pipeline index.