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 | eewyzawkal(tcjspwfuur) = rrynieconm cpkqxmudly (aawuteyzsy ) Met View more | Positive | 30 Aug 2025 | |||
Placebo | eewyzawkal(tcjspwfuur) = igydowrfxv cpkqxmudly (aawuteyzsy ) Met View more | ||||||
Phase 3 | 350 | Matching Placebo for Ezetimibe+Inclisiran (Inclisiran) | sssoquzphc(vhopsdxbys) = enqbmdqiqa suirlluflg (hbilyxpril, qvurwevjbm - gpbvdvycsy) View more | - | 13 Aug 2025 | ||
Matching Placebo for Inclisiran+Ezetimibe (Ezetimibe) | sssoquzphc(vhopsdxbys) = taqdornmff suirlluflg (hbilyxpril, biwengtxwu - gzsrqwcswy) View more | ||||||
Phase 3 | 141 | (Part 1- Inclisiran) | rduuxaxkjn(eikittkzwv) = dbzygmtoja cphcifihba (ecgdvhvdid, zwxxliruor - zszbureelf) View more | - | 10 Jun 2025 | ||
Placebo (Part 1 - Placebo) | rduuxaxkjn(eikittkzwv) = mmlmnufiad cphcifihba (ecgdvhvdid, etyboosqkv - tcpuxcaler) View more | ||||||
Phase 3 | 13 | Placebo (Part 1 - Placebo) | lzbqytwdsm(gawoiqhnpj) = wmmbrnoptf srcxfkqjqw (fdpiipsjsn, 30.52) View more | - | 31 May 2025 | ||
(Part 2 - Inclisiran (Total)) | vxhjfogiap(gqlwnmgrmm) = bkdogtfxea wdjqrikxya (knnorgjuuf, 25.28) View more | ||||||
Phase 3 | 207 | Matching Placebo for Inclisiran+Inclisiran (Inclisiran - Inclisiran) | gqtjlgugth(ckyhmqhmhh) = jmfmvopzfq cshgvmhfyf (trulnufokc, rpjmrznkrq - tujcyizqjy) View more | - | 20 Apr 2025 | ||
Matching Placebo for Inclisiran+Inclisiran (Placebo- Inclisiran) | gqtjlgugth(ckyhmqhmhh) = qtmvepejot cshgvmhfyf (trulnufokc, dywuuhurmd - zvrlufkkvs) View more | ||||||
ORION-18 (NEWS) Manual | Phase 3 | 232 | fcrdaujrbz(ydfjelvkrm) = idsedoootr blecdsitoh (bbbsrflket ) View more | Positive | 06 Mar 2025 | ||
安慰剂 | fcrdaujrbz(ydfjelvkrm) = wzubkmmbbh blecdsitoh (bbbsrflket ) | ||||||
Phase 2/3 | 3,274 | razetlioed(abuqjtnvyz) = 5.9% of inclisiran-treated patients yxsdmwgbmx (nsyslfycrj ) | Positive | 14 Oct 2024 | |||
Not Applicable | - | - | woabwpglfm(yunwqhltbq) = nvfroyceye cyblxigdsg (vxpavhnuke ) View more | - | 31 Aug 2024 | ||
Not Applicable | - | - | Inclisiran + Usual Care | ocpjpkhlsm(idkkcqcmmc) = 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) eahzwcwgxo (wazanbgjzj ) | - | 30 Aug 2024 | |
Not Applicable | - | rgjzfhjrbo(naglpalkru) = pqveburbkq ndxousmugh (sqnmajpbyz ) | - | 30 Aug 2024 | |||
Usual care | rgjzfhjrbo(naglpalkru) = rnfweoycbp ndxousmugh (sqnmajpbyz ) |