idursulfase

Trade name: elaprase

Recombinant proteinapprovedOrphan Drug ^FDA

Approved

Jul 24, 2006

Idursulfase, manufactured by Takeda, is a drug used to treat Hunter syndrome. It is a purified form of iduronate-2-sulfatase, a lysosomal enzyme, and is produced by recombinant DNA technology in a human cell line. — Wikipedia

Clinical trial activity

18 trials · 57 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Sep 1, 2003 (NCT00069641)

Timeline

2000s

Nov 28, 2001
Orphan Drug Designation
Jan 1, 2003
Shire — Earliest Phase 2 Sponsor(trial)
Jul 24, 2006
Shire — Earliest FDA Approval
Jul 24, 2006
Shire — NDA Organization
Jul 24, 2006
Shire — Marketing Organization
Jul 24, 2006
Takeda — NDA Secondary Org
Jan 1, 2009
Shire — Earliest Phase 1 Sponsor(trial)

2010s

Jan 1, 2012
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Mucopolysaccharidosis II

Studied for

Mucopolysaccharidoses · Phase 4

Mechanism of action

Heparan sulfateHYDROLYTIC ENZYME
Heparan sulfate hydrolytic enzyme
Iduronate 2-sulfataseSupplementation
IDS supplementation
- Iduronate 2-sulfatase (IDS) ↗

Approval history

approvedJul 24, 2006

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

Black box warning

Sources

Also known as

alpha-l-iduronate sulfate sulfatase
ec 3.1.6.13
ec 3.1.6.13
elaprase
elaprase
elaprase
elaprase
gsk2788723
iduronate 2-sulfatase
iduronate-2-sulfatase
iduronate-2-sulfatase
iduronate sulfatase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase
idursulfase beta
idursulfase (genetical recombination)

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06031259	Phase 2/Phase 3 (Phase 3)	Jan 1, 2024	Takeda
NCT05494593	Phase 4	Dec 9, 2022	Takeda
NCT05422482	Phase 1	Sep 20, 2022	Green Cross Corporation
NCT05371613	Phase 2/Phase 3 (Phase 3)	Jul 21, 2022	Denali Therapeutics Inc.
NCT05058391	Phase 4	Jan 31, 2022	Shire, Takeda
NCT04573023	Phase 3	Nov 30, 2021	JCR Pharmaceuticals Co., Ltd.
NCT02663024	Phase 2	Dec 1, 2016	Green Cross Corporation
NCT02455622	Phase 4	Jun 1, 2015	Shire
NCT02412787	Phase 2/Phase 3 (Phase 3)	Apr 1, 2015	Shire
NCT02055118	Phase 2/Phase 3 (Phase 3)	Feb 1, 2014	Shire
NCT01645189	Phase 3	Jul 1, 2012	Green Cross Corporation, Sungkyunkwan University
NCT01506141	Phase 1/Phase 2 (Phase 2)	Aug 1, 2010	Shire
NCT01301898	Phase 1/Phase 2 (Phase 2)	May 1, 2010	Green Cross Corporation
NCT00920647	Phase 1/Phase 2 (Phase 2)	Nov 1, 2009	Shire, University of North Carolina at Chapel Hill
NCT00607386	Phase 4	Dec 1, 2007	Covance, Federal University of Rio Grande do Sul, Instytut Pomnik Centrum Zdrowia Dziecka, National Taiwan University, Pharmaceutical Research Associates, Inc. (PRA), PharmaNet, Shire
NCT00630747	Phase 2/Phase 3 (Phase 3)	Sep 1, 2004	ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy, Badalona Hospital Germans Trias i Pujol, Baylor University, CHU Edouard Herriot, Complexo Hupes, Comprehensive Cancer Centers of Nevada, Drottning Silvias Barnsjukhus, Federal University of Mato Grosso do Sul, Federal University of Rio de Janeiro, Federal University of Rio Grande do Sul, Franciscan Skemp Healthcare, Harbin Medical University, Harvard University, Hospital Ducuing, Johannes Gutenburg University, Justus Liebig University Giessen, Karolinska Institute, Mid-Illinois Hematology and Oncology Associates, RWTH Aachen University, Sao Paulo State University, Shire, Spitalul Clinic de Copii, State University of New York, Syracuse, St. Louis University, University Hospital Center of Sao Joao (UHCSJ), University of Bath, University of California, San Francisco, University of Cambridge, University of Duesseldorf, University of Goettingen, University of Hamburg, University of Iowa, University of London, University of Manchester, University of Melbourne, University of Milan, University of Montreal, University of Naples Frederico II, University of Nebraska, University of North Carolina at Chapel Hill, University of Nottingham, University of Padova, University of Pennsylvania, University of Sao Paulo, University of Toronto, University of Utah
NCT00069641	Phase 2/Phase 3 (Phase 3)	Sep 1, 2003	Baylor University, Federal University of Rio Grande do Sul, Johannes Gutenburg University, Shire, University of California, San Francisco, University of Cambridge, University of London, University of Manchester, University of North Carolina at Chapel Hill, Washington University in St. Louis
NCT05795361	N/A	—	Takeda

Showing 18 of 18 trials

Page 1 / 1

Organizations

Research & Development (57)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Shire	For profit	9	9	3	2003
Green Cross Corporation	For profit	4	4	3	2010
Takeda	For profit	4	3	3	2022
Federal University of Rio Grande do Sul	Academic/Hospital	3	0	2	2003
University of North Carolina at Chapel Hill	Academic/Hospital	3	0	2	2003
Baylor University	Academic/Hospital	2	0	1	2003
Johannes Gutenburg University	Academic/Hospital	2	0	1	2003
University of California, San Francisco	Academic/Hospital	2	0	1	2003
University of Cambridge	Academic/Hospital	2	0	1	2003
University of London	Academic/Hospital	2	0	1	2003
University of Manchester	Academic/Hospital	2	0	1	2003
ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy	Academic/Hospital	1	0	1	2004
Badalona Hospital Germans Trias i Pujol	Academic/Hospital	1	0	1	2004
CHU Edouard Herriot	Academic/Hospital	1	0	1	2004
Complexo Hupes	Academic/Hospital	1	0	1	2004
Comprehensive Cancer Centers of Nevada	Academic/Hospital	1	0	1	2004
Covance	For profit	1	0	1	2007
Denali Therapeutics Inc.	For profit	1	1	1	2022
Drottning Silvias Barnsjukhus	Academic/Hospital	1	0	1	2004
Federal University of Mato Grosso do Sul	Academic/Hospital	1	0	1	2004

57 organizations

Page 1 / 3

Marketing (3)

Organization	Org type	Relationship	Date
Shire	For profit	NDA	Jul 24, 2006
Shire	For profit	MKTG	Jul 24, 2006
Takeda	For profit	NDA2	Jul 24, 2006