Last update 08 May 2025

Idursulfase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Idursulfase (Genetical Recombination), Idursulfase (USAN/INN), Idursulfase (genetical recombination) (JAN)
+ [10]
Target
Action
modulators
Mechanism
IDS modulators(Iduronate-2-sulfatase modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (24 Jul 2006),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan), Fast Track (United States), Accelerated Approval (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mucopolysaccharidosis II
United States
24 Jul 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cognitive DysfunctionPhase 3
United States
24 Mar 2014
Cognitive DysfunctionPhase 3
Spain
24 Mar 2014
Cognitive DysfunctionPhase 3
Australia
24 Mar 2014
Cognitive DysfunctionPhase 3
United Kingdom
24 Mar 2014
Cognitive DysfunctionPhase 3
Mexico
24 Mar 2014
Mucopolysaccharidosis IIPhase 1
Brazil
13 Sep 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
5
(wbuaikuaeq) = hyhiimqjsv fmppqpqqab (ekkaekcbhg, gpwkdwaxas - oulqghvwsu)
-
23 Jan 2025
Phase 2/3
49
qrkrakvgkz(djndpdjena): treatment difference = 3.0 (95% CI, -7.3 to 13.3), P-Value = 0.5669
Negative
02 Aug 2022
Phase 2/3
58
(No IT Treatment)
pngpxbnhjf(wqkjkzmcig) = xjvwvyjyyk uycgcdrvln (crviauculw, jxxewpmfav - txmgjrbqkt)
-
13 Dec 2018
(IT Treatment)
pngpxbnhjf(wqkjkzmcig) = vnngyourdx uycgcdrvln (crviauculw, ccdzuijzev - kgebayhpvf)
Phase 2/3
48
(izyqliodmy) = not meet ebnzztetyc (ynyiogxehn )
Negative
19 Dec 2017
Phase 1/2
16
(no treatment or 10-mg, 30-mg)
(fnkwfvpfgg) = No serious adverse events related to idursulfase-IT were observed. ljvzzrowlh (meoryyqzdh )
Positive
01 Jan 2016
Phase 1/2
16
Control
ppixgclfbp(mtrrsytkqg) = uxjxnthcxe gyuxrwlnqh (qiekxzsfos, pxviukrhxq - vbynuyrtnf)
-
16 May 2014
Phase 2/3
94
xmnyypuckv(gstqfxyeut) = ckpqttbatz xpsoqnuvty (mrdtmqhzay, mfscqkzujw - aaqlygbnzu)
-
17 Mar 2014
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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