Last update 01 Nov 2024

Cerliponase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Cerliponase Alfa (Genetical Recombination), Cerliponase alfa (USAN/INN), Cerliponase alfa (genetical recombination) (JAN)
+ [9]
Target
Mechanism
TPP1 stimulants(Tripeptidyl Peptidase 1 stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Orphan Drug (GB), Breakthrough Therapy (US)
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External Link

KEGGWikiATCDrug Bank
D10813-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuronal Ceroid-Lipofuscinoses
EU
30 May 2017
Neuronal Ceroid-Lipofuscinoses
LI
30 May 2017
Neuronal Ceroid-Lipofuscinoses
IS
30 May 2017
Neuronal Ceroid-Lipofuscinoses
NO
30 May 2017
Ceroid Lipofuscinosis, Neuronal, 2
US
27 Apr 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ceroid Lipofuscinosis, Neuronal, 2Phase 1
IT
01 Feb 2016
Ceroid Lipofuscinosis, Neuronal, 2Phase 1
DE
01 Feb 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
14
pppqeawcyh(kwbwlxkdqb) = All subjects experienced ≥1 AE; the most common drug-related AEs were pyrexia and hypersensitivity. Twelve subjects experienced ≥1 serious AE; there were no deaths or discontinuations due to AEs. hstekekbzv (frfjptnhyq )
Positive
04 Sep 2023
(Historical controls)
Not Applicable
8
Intravitreal Cerliponase alfa (rhTPP1) 0.2mg in 0.05ml
bomkwuipck(iwktubvqfo) = ckwnpwgkee igexfhyims (lcnespvmzv )
Positive
23 Apr 2023
bomkwuipck(iwktubvqfo) = rsqqrzjism igexfhyims (lcnespvmzv )
Not Applicable
-
pewergraey(sqdvzoegkb) = fmfbrdyqne glextqqmps (xicgepgjmb )
-
30 Aug 2022
Phase 1/2
24
olnshcfvqt(bafszmmwep) = Fewer subjects reported convulsions over time (21 (88%) during the first 24 weeks of therapy vs 6 (26%) during the last 24 weeks) admcnvlqvw (gjfnvejfmu )
-
25 Aug 2019
Phase 1/2
24
wurdwpeevv(guqbyhvfyk) = Common AEs included pyrexia, vomiting, and convulsion lkslvujxsb (zwvyrvytal )
Positive
24 Jun 2019
Phase 1/2
24
hlxiwntbko(ckramcxqrw) = Common AEs included convulsion uikorqyoqz (mpekuqyeaf )
Positive
05 Oct 2018
Phase 1/2
24
orvngnrgnf(kqnicyzdkb) = All had AEs; most were Grade 1 - 2. Common AEs included pyrexia, hypersensitivity and convulsion. Nineteen (79%) subjects had at least one serious AE, which were mostly consistent with neurodegenerative disease in a pediatric population eaklcazxgd (xczooykjbw )
Positive
05 Sep 2017
Placebo
Phase 1/2
24
qhojnfpcog(ukpxjzzzig) = 17% mxqjvnfhhv (thenzhxmlv )
-
14 Oct 2016
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