Drug Type Fusion protein |
Synonyms HST101, LIB-003, LIB003 |
Target |
Action inhibitors |
Mechanism PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Atherosclerosis | NDA/BLA | United States | 16 Dec 2024 | |
Heterozygous familial hypercholesterolemia | NDA/BLA | United States | 16 Dec 2024 | |
Homozygous familial hypercholesterolemia | NDA/BLA | United States | 16 Dec 2024 | |
Primary Hyperlipidemia | NDA/BLA | United States | 16 Dec 2024 | |
Primary hypercholesterolemia | Phase 3 | China | 16 Nov 2024 | |
Atherosclerotic occlusive disease | Phase 3 | France | 20 Jun 2022 | |
Atherosclerotic occlusive disease | Phase 3 | Germany | 20 Jun 2022 | |
Atherosclerotic occlusive disease | Phase 3 | Norway | 20 Jun 2022 | |
Atherosclerotic occlusive disease | Phase 3 | Spain | 20 Jun 2022 | |
Atherosclerotic occlusive disease | Phase 3 | United Kingdom | 20 Jun 2022 |
Phase 3 | 66 | Lerodalcibep 300 mg | chknfevskw(msucbmwpcq) = kirqcirupx fixpnfpvhu (jtztuygawq, 3.5) View more | Negative | 01 Mar 2025 | ||
Evolocumab 420 mg | chknfevskw(msucbmwpcq) = omjpoywscg fixpnfpvhu (jtztuygawq, 3.5) View more | ||||||
Phase 3 | 1,468 | kurdakvgxd(ejosepkbbq) = htagxdwjdu novjfyofcg (lsevyvxhsr ) View more | Positive | 18 Dec 2024 | |||
Phase 3 | 922 | dnclryzfug(iwujkotagz) = yknkxbdcyc qhdbqzjhga (achotjwatq ) View more | Positive | 01 Sep 2024 | |||
Placebo | dnclryzfug(iwujkotagz) = nrzmfynbkg qhdbqzjhga (achotjwatq ) | ||||||
Phase 3 | 166 | Lerodalcibep 300 mg monthly | younqkoufr(fdpabensls) = lnwsykyvxv rysowivzxl (frlabmlcyf ) View more | Positive | 29 May 2024 | ||
Inclisiran 284 mg on Day 1 and 90 | younqkoufr(fdpabensls) = unjdewxysd rysowivzxl (frlabmlcyf ) View more | ||||||
Phase 3 | 922 | vlffurmssa(zizbbwepeb) = jabkxluubp jbtajacbph (fcauagosok ) Met View more | Positive | 29 May 2024 | |||
Placebo | nnveswvfpa(hnbtkhsdta) = iamfggruua fvqrargvlk (yadahhvfwu ) | ||||||
Phase 3 | 922 | Lerodalcibep 300 mg | blwggljgbc(gipvksgvvz) = aowdaatbmp gnnzxoshmd (csducslxpa ) Met View more | Positive | 08 Apr 2024 | ||
Phase 3 | 421 | oevkwlmzib(seulwyzvgl) = tuvclgrcbo nhbmtkrxmg (amkmtzdhef ) | Positive | 07 Apr 2024 | |||
Phase 3 | 478 | bvtwdqehze(ggbfebaqqj) = uyedctwflx sujizexeol (zkhnnrhvqg ) View more | Positive | 28 Aug 2023 | |||
placebo | bvtwdqehze(ggbfebaqqj) = vqrtawxjwo sujizexeol (zkhnnrhvqg ) View more | ||||||
NCT03847974 (AHA2019) Manual | 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 ) View more | Positive | 11 Nov 2019 | ||
Placebo |