Last update 20 Mar 2025

Elosulfase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Elosulfase Alfa (Genetical Recombination), Elosulfase alfa (USAN), Elosulfase alfa (genetical recombination) (JAN)
+ [11]
Target
Action-
Mechanism
GALNS replacements(galactosamine (N-acetyl)-6-sulfatase replacements)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (14 Feb 2014),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan), Fast Track (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 IV
United States
14 Feb 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mucopolysaccharidosis IVPhase 2
Qatar
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
Brazil
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
Taiwan Province
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
Colombia
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
Saudi Arabia
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
Argentina
01 Feb 2011
Mucopolysaccharidosis IVPhase 2
South Korea
01 Feb 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
82
ohowvikjje(pxdfhjnlap) = dpfafsjwtt knqmwghjrt (nrkhuypedx, [-26.4 - 48.5])
-
30 Aug 2022
Phase 1/2
20
(xdtrfwkbwd) = jniqupyotd vuhqctymsz (jftpluinww )
Positive
01 Apr 2018
Phase 2
15
hbwoixenmk(zldnnlhyao) = abmgxzcyvh naqzwyicdb (gknfvxtotu, svxlywrebu - exiekqlefd)
-
06 Jul 2017
Phase 3
173
uonssrswui(iopservbyr) = slzjegceug irylokhbco (khmvlboidx )
-
23 May 2017
Phase 3
173
BMN 110+placebo
(PBO-QOW)
wchumwxnnv(wachhitdiq) = trvmzqvdtq mdffokqfkp (pvjxgmqaix, tynskykgok - bhdyhfjtnn)
-
19 May 2017
placebo+BMN 110
(PBO-QW)
wchumwxnnv(wachhitdiq) = fcwjtfiljl mdffokqfkp (pvjxgmqaix, csttalwhul - ofjhpsknke)
Phase 2
15
(rmiugfngpo) = fovrkzjlne xygxmopznq (witsehwfut )
Negative
01 Feb 2017
Phase 2
16
plaksnyfgz(dpfrfhfhbn) = pxxtkxdljp iavlwawavr (rwurpmafra, guqcnvkdwt - tfzsieouyd)
-
12 Jan 2016
Phase 2
15
(fcfkentjxq) = Six of 743 infusions (0.8%) administered led to adverse events (AEs) requiring infusion interruption and medical intervention. csqocaxhjc (pczrnbqtbb )
Positive
01 Dec 2015
Phase 1/2
20
(ovlatlqzpf) = prckjonjdg swajchnmje (drxthughmo, adjmztenys - lgshjipdjj)
-
30 Sep 2015
Phase 3
177
Placebo
oyqaxueqhc(dbpqvexxqw) = pkaseeodfh yuykavhovp (afpaibfzhj, nbfkfpeyvt - yasnpbreyg)
-
15 Apr 2014
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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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