Drug Type siRNA |
Synonyms ALN-PCSsc, Inclisiran, 因利司然 + [10] |
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 |
|---|---|---|---|
| Homozygous familial hypercholesterolemia | United States | 12 Feb 2026 | |
| Hypercholesterolemia | Japan | 25 Sep 2023 | |
| Primary Hyperlipidemia | United States | 07 Jul 2023 | |
| Atherosclerosis | Australia | 14 Sep 2021 | |
| Heterozygous familial hypercholesterolemia | Canada | 26 Jul 2021 | |
| Hypercholesterolemia, Familial | 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 |
|---|---|---|---|---|
| Acute Coronary Syndrome | Phase 3 | China | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Japan | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Japan | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Japan | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Japan | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Argentina | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Argentina | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Argentina | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Australia | 03 Oct 2025 | |
| Acute Coronary Syndrome | Phase 3 | Canada | 03 Oct 2025 |
Phase 4 | 1,770 | bkcxzaurdt(gagghzquom) = sajqgxuvfz yljvwsijdu (ilkyafdeer ) Met View more | Positive | 30 Aug 2025 | |||
Placebo | bkcxzaurdt(gagghzquom) = arrrprivkw yljvwsijdu (ilkyafdeer ) Met View more | ||||||
Phase 3 | 350 | Matching Placebo for Ezetimibe+Inclisiran (Inclisiran) | iqykmktxam(vnfaxxplhu) = hkdsqeskii jryrnbctov (iqacytyvzc, bcxyagrpzm - nrwuzhyjml) View more | - | 13 Aug 2025 | ||
Matching Placebo for Inclisiran+Ezetimibe (Ezetimibe) | iqykmktxam(vnfaxxplhu) = fixiqvyihk jryrnbctov (iqacytyvzc, lqalvzlurb - drizhossao) View more | ||||||
Phase 3 | 350 | lzxfpkukch(xlcjkshlqk) = ikdhflgnxw ypnauhgetg (dtlcdfyeyo ) | Positive | 01 Jul 2025 | |||
lzxfpkukch(xlcjkshlqk) = ywldghzght ypnauhgetg (dtlcdfyeyo ) | |||||||
Phase 3 | 141 | (Part 1- Inclisiran) | gmminvpuuk(gcrzbzvbze) = xmgnfjqyfz eedseweewi (xyzsjzhkmb, lyebdmhpsz - grorrwoayd) View more | - | 10 Jun 2025 | ||
Placebo (Part 1 - Placebo) | gmminvpuuk(gcrzbzvbze) = viyyddqmjy eedseweewi (xyzsjzhkmb, udwhphydhg - qmthgbfqxn) View more | ||||||
Phase 3 | 13 | Placebo (Part 1 - Placebo) | uiwhcxrxln(xjrtcvnidw) = kibwdlickp mwrnlutuxq (zmcyglfsyv, 30.52) View more | - | 31 May 2025 | ||
(Part 2 - Inclisiran (Total)) | auqrbsjtue(npuvfcvrqm) = cjeceyzrcv qaflbhtwbt (jzsjrlimkj, 25.28) View more | ||||||
Phase 3 | 207 | Matching Placebo for Inclisiran+Inclisiran (Inclisiran - Inclisiran) | uhqyxeatzc(oyflzdfgil) = hnqgqfqlgd ibwjszuhqz (hidwxpismc, skjsywmfqf - zujkhldycx) View more | - | 20 Apr 2025 | ||
Matching Placebo for Inclisiran+Inclisiran (Placebo- Inclisiran) | uhqyxeatzc(oyflzdfgil) = pbohnixdel ibwjszuhqz (hidwxpismc, wnwjovcduw - jhddyhvxdj) View more | ||||||
ORION-18 (NEWS) Manual | Phase 3 | 232 | jfnaeukqek(mbnconmhhq) = pxuhkyetbn hynejniqse (tkmvnxwhhi ) View more | Positive | 06 Mar 2025 | ||
安慰剂 | jfnaeukqek(mbnconmhhq) = fqbgakxcit hynejniqse (tkmvnxwhhi ) | ||||||
Phase 2/3 | 3,274 | qcnowquvtr(tmzctbwxmu) = 5.9% of inclisiran-treated patients dxeguygkdw (ovvphumcco ) | Positive | 14 Oct 2024 | |||
Not Applicable | - | - | cdkvysfqhz(xpfcvesgcs) = zjpeafkbmk cvwmyrsjrb (xkflbsabjk ) View more | - | 31 Aug 2024 | ||
Not Applicable | - | - | Inclisiran + Usual Care | hdgoqdzloc(aovmecjegv) = 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) ccxefhoskb (pmnvjdvksj ) | - | 30 Aug 2024 |





