Last update 25 Apr 2025

Lerodalcibep

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
HST101, LIB-003, LIB003
Target
Action
inhibitors
Mechanism
PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AtherosclerosisNDA/BLA
United States
16 Dec 2024
Heterozygous familial hypercholesterolemiaNDA/BLA
United States
16 Dec 2024
Homozygous familial hypercholesterolemiaNDA/BLA
United States
16 Dec 2024
Primary HyperlipidemiaNDA/BLA
United States
16 Dec 2024
Primary hypercholesterolemiaPhase 3
China
16 Nov 2024
Atherosclerotic occlusive diseasePhase 3
France
20 Jun 2022
Atherosclerotic occlusive diseasePhase 3
Germany
20 Jun 2022
Atherosclerotic occlusive diseasePhase 3
Norway
20 Jun 2022
Atherosclerotic occlusive diseasePhase 3
Spain
20 Jun 2022
Atherosclerotic occlusive diseasePhase 3
United Kingdom
20 Jun 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
66
Lerodalcibep 300 mg
chknfevskw(msucbmwpcq) = kirqcirupx fixpnfpvhu (jtztuygawq, 3.5)
Negative
01 Mar 2025
Evolocumab 420 mg
chknfevskw(msucbmwpcq) = omjpoywscg fixpnfpvhu (jtztuygawq, 3.5)
Phase 3
1,468
kurdakvgxd(ejosepkbbq) = htagxdwjdu novjfyofcg (lsevyvxhsr )
Positive
18 Dec 2024
Phase 3
922
dnclryzfug(iwujkotagz) = yknkxbdcyc qhdbqzjhga (achotjwatq )
Positive
01 Sep 2024
Placebo
dnclryzfug(iwujkotagz) = nrzmfynbkg qhdbqzjhga (achotjwatq )
Phase 3
166
Lerodalcibep 300 mg monthly
younqkoufr(fdpabensls) = lnwsykyvxv rysowivzxl (frlabmlcyf )
Positive
29 May 2024
Inclisiran 284 mg on Day 1 and 90
younqkoufr(fdpabensls) = unjdewxysd rysowivzxl (frlabmlcyf )
Phase 3
922
vlffurmssa(zizbbwepeb) = jabkxluubp jbtajacbph (fcauagosok )
Met
Positive
29 May 2024
Placebo
nnveswvfpa(hnbtkhsdta) = iamfggruua fvqrargvlk (yadahhvfwu )
Phase 3
922
blwggljgbc(gipvksgvvz) = aowdaatbmp gnnzxoshmd (csducslxpa )
Met
Positive
08 Apr 2024
Phase 3
421
oevkwlmzib(seulwyzvgl) = tuvclgrcbo nhbmtkrxmg (amkmtzdhef )
Positive
07 Apr 2024
Phase 3
478
bvtwdqehze(ggbfebaqqj) = uyedctwflx sujizexeol (zkhnnrhvqg )
Positive
28 Aug 2023
placebo
bvtwdqehze(ggbfebaqqj) = vqrtawxjwo sujizexeol (zkhnnrhvqg )
Phase 2
32
tspmmjecye(vyhjhqrnnk) = LIB was well tolerated with all AEs considered mild and not drug related. Injection site reactions were minimal and considered mild when present. gbmwfqobhs (qenmkacjrt )
Positive
11 Nov 2019
Placebo
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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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