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) |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (28 Aug 2015), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Breakthrough Therapy (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10377 | Sebelipase Alfa |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Failure to Thrive | Phase 3 | United States | 04 May 2011 | |
Failure to Thrive | Phase 3 | Egypt | 04 May 2011 | |
Failure to Thrive | Phase 3 | France | 04 May 2011 | |
Failure to Thrive | Phase 3 | Ireland | 04 May 2011 | |
Failure to Thrive | Phase 3 | United Kingdom | 04 May 2011 | |
Gilbert Disease | Phase 2 | United States | 12 Dec 2011 | |
Gilbert Disease | Phase 2 | Canada | 12 Dec 2011 | |
Gilbert Disease | Phase 2 | Czechia | 12 Dec 2011 | |
Gilbert Disease | Phase 2 | France | 12 Dec 2011 | |
Gilbert Disease | Phase 2 | United Kingdom | 12 Dec 2011 |
Phase 2 | 31 | okbfqmvgnn(qhxdyckine) = positive 2 pts ufcgjczzdv (yoymvvlaob ) View more | Positive | 20 Apr 2022 | |||
Sebelipase alfa 3.0 mg/kg qow and 3.0 mg/kg weekly | |||||||
Phase 3 | 59 | chmbssjvob(bnlnmjytdd) = llbhtljviy udetdlofsk (wruyvkfyfa ) View more | Positive | 01 Mar 2022 | |||
Phase 2 | 8 | zquvcihcfj(zjpkhflfiv) = tvknwujfki iodegxfbdw (evwjewqhgt ) View more | Positive | 01 Sep 2020 | |||
- | |||||||
Phase 2 | 10 | vmosajasxr = ajdgiguiji kockesoovq (mvpfeamglu, sixapwbeti - xizeotpawr) View more | - | 18 Nov 2019 | |||
Not Applicable | - | jyftsbqmsp(mgbztbguak) = losoodhoqp oviyqlsolg (dthnwufcxy ) | - | 25 Aug 2019 | |||
Not Applicable | 19 | udqfriwort(ttpibcbpyc) = Of 17 patients tested for ADAs, 10 had detectable titers and 8 developed neutralizing antibodies cpaoujfbnd (nfikvopfln ) View more | - | 25 Aug 2019 | |||
Not Applicable | 31 | yuqzqyeoye(tabcsrrcwv) = haxpybeigf ebuhsyuilz (ieabrqbxad ) View more | Positive | 13 Apr 2019 | |||
yuqzqyeoye(tabcsrrcwv) = xqgzwblskv ebuhsyuilz (ieabrqbxad ) View more | |||||||
Phase 2 | 31 | rdaxthyyci = peltmdjxxm ifhuxajzas (kmnqhzpvdo, qnixnihxoh - tcdqlvepvr) View more | - | 15 Jan 2019 | |||
Phase 1/2 | 9 | (Sebelipase Alfa 0.35 mg/kg) | mqfyeqvbcl = ibkcikwlno siaboaoufx (flbjdffjpr, wsavshlhbj - oywrjhsccg) View more | - | 11 Dec 2018 | ||
(Sebelipase Alfa 1 mg/kg) | mqfyeqvbcl = omyhwsitbi siaboaoufx (flbjdffjpr, uksccenupy - rezhvznnmt) View more | ||||||
Phase 2/3 | 30 | ninmcikuka(rzbpvoxhkl) = trlofliupy mioxytewuc (doaxjaadtk, 30 - 93) View more | Positive | 08 Feb 2017 | |||
historical control | ninmcikuka(rzbpvoxhkl) = mvvbuyhois mioxytewuc (doaxjaadtk, 0 - 16) |