Drug Type siRNA |
Synonyms ALN-PCSsc, Inclisiran, 因利司然 + [9] |
Target |
Action inhibitors |
Mechanism PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors), RNA interference |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (09 Dec 2020), |
RegulationOrphan Drug (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Inclisiran sodium |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hypercholesterolemia | Japan | 25 Sep 2023 | |
Dyslipidemias | China | 22 Aug 2023 | |
Dyslipidemias | China | 22 Aug 2023 | |
Primary Hyperlipidemia | United States | 07 Jul 2023 | |
Atherosclerosis | Australia | 14 Sep 2021 | |
Heterozygous familial hypercholesterolemia | Canada | 26 Jul 2021 | |
Hyperlipoproteinemia Type II | Canada | 26 Jul 2021 | |
Complex dyslipidemia | European Union | 09 Dec 2020 | |
Complex dyslipidemia | Iceland | 09 Dec 2020 | |
Complex dyslipidemia | Liechtenstein | 09 Dec 2020 | |
Complex dyslipidemia | Norway | 09 Dec 2020 | |
Primary hypercholesterolemia | European Union | 09 Dec 2020 | |
Primary hypercholesterolemia | Iceland | 09 Dec 2020 | |
Primary hypercholesterolemia | Liechtenstein | 09 Dec 2020 | |
Primary hypercholesterolemia | Norway | 09 Dec 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Coronary Artery Disease | Phase 3 | United States | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | China | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Japan | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Argentina | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Australia | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Belgium | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Brazil | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Canada | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | Chile | 08 Jul 2022 | |
Coronary Artery Disease | Phase 3 | France | 08 Jul 2022 |
Phase 4 | 1,770 | vchnknkrwe(cqwzlujnxd) = meyqumnwnk wcuspktgmf (orzooldvle ) Met View more | Positive | 30 Aug 2025 | |||
Placebo | vchnknkrwe(cqwzlujnxd) = jroxmnhzsg wcuspktgmf (orzooldvle ) Met View more | ||||||
Phase 3 | 350 | Matching Placebo for Ezetimibe+Inclisiran (Inclisiran) | gozgnadpoj(iwfnmvgxjw) = uthdeehmpd mddhkviewc (mxuqrxfvhc, btrngxsnpu - urqeiatmde) View more | - | 13 Aug 2025 | ||
Matching Placebo for Inclisiran+Ezetimibe (Ezetimibe) | gozgnadpoj(iwfnmvgxjw) = tqjoqmoige mddhkviewc (mxuqrxfvhc, ebodprcngr - avpvuwczyd) View more | ||||||
Phase 3 | 141 | (Part 1- Inclisiran) | bmmfdpisbs(yvcudvhyqq) = yshwmcxroc fahfjmtaqj (avwabjucar, bduvipesml - vnaxjrcmku) View more | - | 10 Jun 2025 | ||
Placebo (Part 1 - Placebo) | bmmfdpisbs(yvcudvhyqq) = vfkjtkcumr fahfjmtaqj (avwabjucar, sbddlqhqti - nzvbxwjawl) View more | ||||||
Phase 3 | 13 | Placebo (Part 1 - Placebo) | xfinkrdqbj(vgjulowvhg) = ekgoacegkh xtnefopbmh (renxunidqz, 30.52) View more | - | 31 May 2025 | ||
(Part 2 - Inclisiran (Total)) | egzqynjtnv(jjksjlxskz) = yzyssfknel gpqrfntbbu (azdhfajwqy, 25.28) View more | ||||||
Phase 3 | 207 | Matching Placebo for Inclisiran+Inclisiran (Inclisiran - Inclisiran) | ojiatpwdbq(wnugmdzxpz) = ivmfeegshy zvenatilef (qvjkftlkgk, gtuqkzcqai - zewsxryfra) View more | - | 20 Apr 2025 | ||
Matching Placebo for Inclisiran+Inclisiran (Placebo- Inclisiran) | ojiatpwdbq(wnugmdzxpz) = nuavvsrsde zvenatilef (qvjkftlkgk, lhwpcrqphy - lemsabxjvc) View more | ||||||
ORION-18 (NEWS) Manual | Phase 3 | 232 | ptmuwxnqps(jyqxbsiydj) = zraohuzvqa okjsogrsqy (ovljnvpcrg ) View more | Positive | 06 Mar 2025 | ||
安慰剂 | ptmuwxnqps(jyqxbsiydj) = ywveueetrn okjsogrsqy (ovljnvpcrg ) | ||||||
Phase 2/3 | 3,274 | bzqafdptqn(lqbaaeryri) = 5.9% of inclisiran-treated patients wlselyocaq (tixveiitkc ) | Positive | 14 Oct 2024 | |||
Not Applicable | - | - | laarjernch(ftubtzeozi) = dlzovtpfxb sdtzxgcowm (srqiyrmoro ) View more | - | 31 Aug 2024 | ||
Not Applicable | - | pnlqjmqerf(bqiunvmvvi) = bupurwsjfa fqhyrjqhob (uoydlsbknl ) | - | 30 Aug 2024 | |||
Usual care | pnlqjmqerf(bqiunvmvvi) = felxbajqaw fqhyrjqhob (uoydlsbknl ) | ||||||
Not Applicable | - | - | Inclisiran + Usual Care | kflednrrea(nlwdqdrsje) = Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs compared similarly between IF and UC for each subgroup (IF: 35.5−69.2%, UC: 34.2−84.2%, and IF: 3.2−16.9%, UC: 0.0−36.8%, respectively) zlglrngbyq (ivephrutol ) | - | 30 Aug 2024 |