Drugs / idursulfase
idursulfase
also known as
ELAPRASE · idursulfase-IT · DRX006A · EC 3.1.6.13 · GC1111 · HGT-2310 · Iduronate-2-sulfatase · Idursulfasa · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ELAPRASE | — | 2013-06-24 | fda.gov ↗ |
| Approved | EU (EMA) | Elaprase | — | 2007-01-08 | europa.eu ↗ |
| Approved | US (FDA) | ELAPRASE | — | 2006-07-24 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01506141 | Aug 2010 → Apr 2024 | Hunter-Macdonald syndrome | Takeda | Completed | No outcome recorded |
| Phase 1/2 | NCT00920647 | Nov 2009 → Oct 2012 | — | Shire | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02663024 | Dec 2016 → Dec 2019 | mucopolysaccharidosis type 2 | Green Cross Corporation | Unknown | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT06031259 | Mar 2024 → Jan 2029 expected | — | Takeda | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05371613 | Jul 2022 → Dec 2027 expected | mucopolysaccharidosis type 2 | Denali Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02412787 | Apr 2015 → Apr 2024 | — | Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT02055118 | Mar 2014 → Sep 2017 | Hunter-Macdonald syndrome | Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT00630747 | Sep 2004 → Jan 2008 | mucopolysaccharidosis type 2 | Shire | Completed | No outcome recorded |
| Phase 2/3 | NCT00069641 | Sep 2003 → Mar 2005 | mucopolysaccharidosis type 2 | Shire | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04573023 | Feb 2022 → Oct 2027 expected | mucopolysaccharidosis type 2 | JCR Pharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05058391 | Apr 2022 → Apr 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02455622 | Oct 2015 → Jul 2025 | — | Shire | Completed | No outcome recorded |
| Phase 4 | NCT00607386 | Dec 2007 → Jul 2011 | Hunter-Macdonald syndrome, mucopolysaccharidosis type 2 | Shire | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01301898 Comparator | May 2010 → Mar 2011 | mucopolysaccharidosis type 2 | Green Cross Corporation | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05494593 Background | Feb 2023 → Aug 2025 | mucopolysaccharidosis type 2 | Takeda | Withdrawn | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05795361 Background | — | Hunter-Macdonald syndrome | Takeda | Available | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-01-26 | Takeda | Shire’s Investigational SHP609, Idursulfase-IT, Receives FDA Fast Track Designation For The Treatment Of Neurocognitive Decline Associated With Hunter Syndrome takeda.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | idursulfase | “Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.” NCT00069641 ↗ |
| Known as | DRX006A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | EC 3.1.6.13 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | ELAPRASE | “Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.” NCT00920647 ↗6“administered as the standard of care: idursulfase (ELAPRASE®)” NCT04573023 ↗ |
| Known as | GC1111 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | HGT-2310 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | Iduronate-2-sulfatase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | Idursulfasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Known as | idursulfase-IT | “A formulation of idursulfase for intrathecal administration (idursulfase-IT) is under investigation for the treatment of neuronopathic MPS II.” PMID 35961250 ↗ Aug 20221“Intrathecal (IT) idursulfase-IT for the treatment of cognitive impairment is being investigated” PMID 35588317 ↗ May 2022 |
| Known as | Sulfatase, l-idurono- | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201826 ↗ |
| Modality | Protein / enzyme biologic | “iduronate-2-sulfatase enzyme replacement therapy” NCT00069641 ↗ |
| Route | Other | “Patients will receive weekly infusions of idursulfase at a dose of 0.5 mg/kg.” NCT00069641 ↗ |