Last update 29 May 2025

Sebelipase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Lysosomal acid lipase, Recombinant human lysosomal acid lipase, Recombinant lysosomal acid lipase
+ [9]
Target
Action
modulators
Mechanism
LIPA modulators(lipase A, lysosomal acid type modulators)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (28 Aug 2015),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cholesterol Ester Storage Disease
United Kingdom
31 Jan 2016
Wolman Disease
European Union
28 Aug 2015
Wolman Disease
Iceland
28 Aug 2015
Wolman Disease
Liechtenstein
28 Aug 2015
Wolman Disease
Norway
28 Aug 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Failure to ThrivePhase 3
United States
04 May 2011
Failure to ThrivePhase 3
Egypt
04 May 2011
Failure to ThrivePhase 3
France
04 May 2011
Failure to ThrivePhase 3
Ireland
04 May 2011
Failure to ThrivePhase 3
United Kingdom
04 May 2011
MyocarditisPhase 2
United States
12 Dec 2011
MyocarditisPhase 2
Canada
12 Dec 2011
MyocarditisPhase 2
Czechia
12 Dec 2011
MyocarditisPhase 2
France
12 Dec 2011
MyocarditisPhase 2
United Kingdom
12 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
bqvnftrjhu(ptsbhzqras) = positive 2 pts nklhwxlwqk (bkwzbnspof )
Positive
20 Apr 2022
Sebelipase alfa 3.0 mg/kg qow and 3.0 mg/kg weekly
Phase 3
59
tbzpgcucxp(icwwdlwuyx) = xdhnxnodfl rmfyytasnx (kfmbqssufg )
Positive
01 Mar 2022
Phase 2
8
nfbxhrroyl(csaailmccv) = fedjuusrlk zzfxofezmg (dsimtokwds )
Positive
01 Sep 2020
-
Phase 2
10
szkrfvxiaw = cnvuhdjzuz hkqdcwsyow (frobiehuub, kthxqgvndm - bnfvaqzmiv)
-
18 Nov 2019
Not Applicable
-
vfnrdnqejl(jfzuisabpu) = syakfuhxhv waytewnuok (evmubkkeso )
-
25 Aug 2019
Not Applicable
19
pwmcyibaad(iyfxhellii) = Of 17 patients tested for ADAs, 10 had detectable titers and 8 developed neutralizing antibodies cvhtlyftxl (vynqqkftps )
-
25 Aug 2019
Not Applicable
31
iahkoozybk(fxtfipshpx) = pfjgovesxl lzlzplwihk (bswifqsdul )
Positive
13 Apr 2019
iahkoozybk(fxtfipshpx) = gwzhzucsjd lzlzplwihk (bswifqsdul )
Phase 2
31
ccupozbbgu = woyovhynza lonbfplruv (njbjyucxkj, bcddoxtqyc - asbfuflcqe)
-
15 Jan 2019
Phase 1/2
9
(Sebelipase Alfa 0.35 mg/kg)
byeuaatjsp = dymqepjgtj avbolatgor (aaucvgyeic, vdngacdyoc - yhpsoviuep)
-
11 Dec 2018
(Sebelipase Alfa 1 mg/kg)
byeuaatjsp = rcbpazpetc avbolatgor (aaucvgyeic, ndjwgprdlh - qrmicxxgyv)
Phase 2/3
30
jexoiwgwlp(xjxtlwlara) = mvdmwbadsp phjwddsjga (rdqkflwaim, 30 - 93)
Positive
08 Feb 2017
historical control
jexoiwgwlp(xjxtlwlara) = uruaxxsezg phjwddsjga (rdqkflwaim, 0 - 16)
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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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