Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LEQVIO | — | 2025-07-31 – 2026-02-12 | fda.gov ↗ |
| Approved | US (FDA) | LEQVIO | — | 2021-12-22 | fda.gov ↗ |
| Approved | EU (EMA) | Leqvio | — | 2020-12-09 | europa.eu ↗ |
Trials 46 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02314442 Comparator | Dec 2014 → May 2015 | hyperlipidemia | Alnylam Pharmaceuticals | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07421232 Comparator | Dec 2024 → Aug 2025 | hyperlipidemia | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06813911 Comparator | Apr 2025 → Feb 2028 expected | atherosclerotic cardiovascular disease | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05004675 Comparator | Jun 2022 → May 2024 | atherosclerotic cardiovascular disease, hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06909565 Comparator | Jul 2025 → Oct 2029 expected | — | Duke University | Recruiting | No outcome recorded |
| Phase 4 | NCT06865885 Comparator | Apr 2025 → Dec 2026 expected | low density lipoprotein cholesterol, mild elevation of, metabolic syndrome X | University of California, San Diego | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05587621 Comparator | Apr 2024 → Apr 2026 overdue | ST-elevation myocardial infarction, low density lipoprotein cholesterol, mild elevation of | Jena University Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 25 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-08-30 | Novartis Pharmaceuticals | Novartis Leqvio® shows statistically significant and clinically meaningful early LDL-C goal achievement with less muscle pain novartis.com ↗ |
| 2024-08-28 | Novartis Pharmaceuticals | Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk novartis.com ↗ |
| 2024-04-06 | Novartis Pharmaceuticals | New Novartis data show early addition of twice-yearly* Leqvio® (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting novartis.com ↗ |
| 2023-08-28 | Novartis Pharmaceuticals | Novartis presents new long-term Leqvio® (inclisiran) data demonstrating consistent efficacy and safety beyond six years novartis.com ↗ |
| 2022-11-07 | Novartis Pharmaceuticals | New long-term Leqvio® (inclisiran) data from Novartis show sustained efficacy and safety over four years novartis.com ↗ |
| 2021-12-22 | Novartis Pharmaceuticals | FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year novartis.com ↗ |
| 2021-12-22 | Alnylam Pharmaceuticals | Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C alnylam.com ↗ |
| 2021-11-08 | Novartis Pharmaceuticals | Leqvio®* (inclisiran) reduced LDL-C in people who are overweight or obese novartis.com ↗ |
| 2021-09-01 | Novartis Pharmaceuticals | World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio® ▼(inclisiran) novartis.com ↗ |
| 2021-08-30 | Novartis Pharmaceuticals | Novartis Leqvio®* (inclisiran) analyses show effective and sustained LDL-C reduction in two sub-populations of patients with ASCVD novartis.com ↗ |
| 2020-12-18 | Novartis Pharmaceuticals | Novartis receives complete response letter from U.S. FDA for inclisiran novartis.com ↗ |
| 2020-12-11 | Novartis Pharmaceuticals | Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year** novartis.com ↗ |
| 2020-11-13 | Novartis Pharmaceuticals | New Novartis analyses for investigational inclisiran demonstrate consistently effective and sustained LDL-C reduction at month 17 regardless of age and gender novartis.com ↗ |
| 2020-10-16 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol novartis.com ↗ |
| 2020-08-30 | Novartis Pharmaceuticals | Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran novartis.com ↗ |
| 2020-03-28 | Novartis Pharmaceuticals | Novartis new analysis further shows durable and potent LDL-C reduction with inclisiran, an investigational first-in-class siRNA cholesterol-lowering treatment novartis.com ↗ |
| 2020-03-18 | Novartis Pharmaceuticals | Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy novartis.com ↗ |
| 2020-01-06 | Novartis Pharmaceuticals | Novartis successfully completes acquisition of The Medicines Company, adding a potentially first-in-class, investigational cholesterol-lowering therapy inclisiran novartis.com ↗ |
| 2019-11-24 | Novartis Pharmaceuticals | Novartis to acquire The Medicines Company for USD 9.7 bn, adding inclisiran, a potentially transformational investigational cholesterol-lowering therapy to address leading global cause of death novartis.com ↗ |
| 2017-11-06 | Alnylam Pharmaceuticals | The Medicines Company and Alnylam Pharmaceuticals Announce Initiation of Phase III Clinical Trials of Inclisiran alnylam.com ↗ |
| 2017-08-28 | Alnylam Pharmaceuticals | New, One-Year Data from ORION-1 Phase II Study of Inclisiran Extends Excellent Long-Term Efficacy and Safety Profile, Affirming Dose for Phase III Trials alnylam.com ↗ |
| 2017-04-26 | Alnylam Pharmaceuticals | The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran alnylam.com ↗ |
| 2017-03-17 | Alnylam Pharmaceuticals | The Medicines Company and Alnylam Pharmaceuticals Report Positive Final Results from ORION-1 Phase II Study of Inclisiran alnylam.com ↗ |
| 2016-11-15 | Alnylam Pharmaceuticals | The Medicines Company and Alnylam Pharmaceuticals Present Positive Results from ORION-1 Phase 2 Study of Inclisiran (formerly PCSK9si) alnylam.com ↗ |
| 2016-11-13 | Alnylam Pharmaceuticals | Alnylam Pharmaceuticals and The Medicines Company Announce Publication of Phase 1 Clinical Data with Inclisiran (ALN- PCSsc) in the New England Journal of Medicine alnylam.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inclisiran | “Patients randomized to the "PCSK9i early" intensified therapy group will receive initial treatment with a PCSK9 inhibitor-either evolocumab 140 mg or alirocumab 75 mg, both...” NCT06791031 ↗48“BACKGROUND: Inclisiran (ALN-PCSsc) is a long-acting RNA interference (RNAi) therapeutic agent that inhibits the synthesis of proprotein convertase subtilisin-kexin type 9...” PMID 27959715 ↗ Nov 2016 |
| Known as | ALN-PCSSC | “BACKGROUND: Inclisiran (ALN-PCSsc) is a long-acting RNA interference (RNAi) therapeutic agent that inhibits the synthesis of proprotein convertase subtilisin-kexin type 9...” PMID 27959715 ↗ Nov 2016 |
| Known as | inclisiran sodium | “Patients randomized to the "PCSK9i early" intensified therapy group will receive initial treatment with a PCSK9 inhibitor-either evolocumab 140 mg or alirocumab 75 mg, both...” NCT06791031 ↗16“Inclisiran (inclisiran sodium 300 mg subcutaneous (s.c.) for participants with body weight ≥23 kg and inclisiran sodium 180 mg s.c. for participants with body weight \<23 kg.” NCT06597019 ↗ “The ORION-18 was a phase 3 double-blind trial in which patients were randomized 1:1 to receive either 300 mg inclisiran sodium or matching placebo on days 1, 90, and 270.” PMID 38371290 ↗ Nov 2023 “Patients eligible for part 1 (double-blind, 6 months) were randomized 2:1 to receive either 300 mg of inclisiran sodium (equivalent to 284 mg of inclisiran) or placebo.” PMID 37850379 ↗ Oct 2023 “Patients will be treated with inclisiran sodium 300 mg or placebo, administered subcutaneously at Day 1, Day 90, and every 6 months thereafter.” PMID 42203164 ↗ May 2026 “The participants will receive Inclisiran sodium 300 mg subcutaneous at randomization (Day 1, Baseline visit) and Day 90” NCT07102628 ↗ “subcutaneous injections of inclisiran sodium (at a dose of 300 mg) or matching placebo on days 1, 90, 270, and 450.” PMID 32197277 ↗ Mar 2020 “Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL solution for subcutaneous injection” NCT04652726 ↗ “100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) in 0.5 mL solution.” NCT04774003 ↗ “Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL” NCT05739383 ↗ “Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL” NCT06865885 ↗ “Inclisiran sodium 300 mg s.c. (administered at Day 1 and Day 90)” NCT06431763 ↗ “300 mg of Inclisiran Sodium Given as Subcutaneous Injections” NCT03399370 ↗ “Active ingredient: inclisiran sodium” NCT06494501 ↗ “Drug: Inclisiran sodium” NCT04666298 ↗ “Drug: Inclisiran sodium” NCT06338293 ↗ “Drug: Inclisiran Sodium” NCT05192941 ↗ |
| Known as | KJX839 | “Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood.” NCT04807400 ↗ |
| Known as | Leqvio | “Inclisiran (Leqvio®) 300mg” NCT07421232 ↗ |
| Action | Inhibit | “inhibits the synthesis of proprotein convertase subtilisin-kexin type 9 (PCSK9)” PMID 27959715 ↗ Nov 2016 |
| Modality | Small interfering RNA (siRNA) | “long-acting RNA interference (RNAi) therapeutic agent” PMID 27959715 ↗ Nov 2016 |
| Route | Subcutaneous | “subcutaneous injection of inclisiran” PMID 27959715 ↗ Nov 2016 |
| Target | PCSK9 | “inhibits the synthesis of proprotein convertase subtilisin-kexin type 9 (PCSK9)” PMID 27959715 ↗ Nov 2016 |