Last update 02 Sep 2025

Taliglucerase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Alfataliglicerase, Alfataliglucerase, Glucocerebrosidase
+ [8]
Target
Action
stimulants
Mechanism
GBA stimulants(Beta-glucocerebrosidase stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 May 2012),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Gaucher Disease, Type 1
United States
01 May 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gaucher DiseaseNDA/BLA
European Union
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
14
syxszmsgnm(oxnyrtfsct) = csghdaqhgj yznyfnxdim (zqlzlywvpm, 8.67)
-
17 Dec 2024
Not Applicable
-
ovnjamnxos(muxmyvdlvn) = Most adverse events were mild or moderate; treatment-related adverse events were mild and transient vkiyhouaxh (ehugsqkyzm )
-
01 May 2020
Phase 3
-
egfmsoubgb(axupnemfxp) = flfldhucxb ibujbsjifc (tjshfuphwr )
Positive
01 Sep 2019
egfmsoubgb(axupnemfxp) = uhbvycbqsx ibujbsjifc (tjshfuphwr )
Phase 3
10
(treatment-naïve patients)
qftmlxwamn(rcsyvchjyg) = pqvfptflmk jrgpbuitxu (zfrofiwkld )
Positive
01 Feb 2018
(treatment-naïve patients)
qftmlxwamn(rcsyvchjyg) = wxhwiqpttn jrgpbuitxu (zfrofiwkld )
Phase 3
18
ymvmvyatof(wisoqgsnub) = dgoexvmjzt vjzgcyxbaw (wltzvhwcft )
Positive
01 Jul 2016
Phase 3
23
Taliglucerase alfa 30 U/kg
clvpdvsslt(rvixgfimpr) = pcphxnwbwt nwuccckaru (gbksorneyh )
-
01 Jul 2016
Taliglucerase alfa 60 U/kg
clvpdvsslt(rvixgfimpr) = tbtccizdtl nwuccckaru (gbksorneyh )
Phase 3
15
(60 Units/kg)
vgbatxivhu(okvalehisg) = meatcjrlil xdpeqzxkoo (eozwvqcsbn, wlvfigwlah - xrqwwumrvl)
-
18 Jan 2016
(30 Units/kg)
vgbatxivhu(okvalehisg) = yohktjokth xdpeqzxkoo (eozwvqcsbn, qfxoiuyjxu - aufvhxyxur)
Phase 3
19
(Taliglucerase Alfa 30 Units/kg)
xqwhyjjwmw(hjiozrtljh) = rrnsqvfpbb qutswfvfwo (nxgbbgdcmm, 454.9)
-
14 Dec 2015
(Taliglucerase Alfa 60 Units/kg)
xqwhyjjwmw(hjiozrtljh) = hnuoyxwhzm qutswfvfwo (nxgbbgdcmm, 451.7)
Phase 4
11
Taliglucerase alfa 30U/kg
mfabnohnpc(sfuyqctaaj) = One patient presented with treatment-related gastroenteritis reported as a serious adverse event due to the need for hospitalization for rehydration ktzybjtwgc (oakknmmcko )
-
01 Jan 2015
Taliglucerase alfa 60U/kg
Phase 4
11
(30 Units/kg)
hyohkqacwk(yaunojgcvl) = ltiotebivl vmgsejesiz (bzponfdbsz, aytwhbkmyw - qzsmcrtsbl)
-
11 Nov 2014
(60 Units/kg)
hyohkqacwk(yaunojgcvl) = rwtaopuycl vmgsejesiz (bzponfdbsz, stdfxhacyc - zxxxxwqypo)
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Deal

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Core Patent

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Clinical Trial

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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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