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Last update 09 Sep 2026

Inclisiran sodium

Last update 09 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

siRNA

Synonyms

ALN-PCSsc, Inclisiran, 因利司然

+ [10]

Target

PCSK9

Action

inhibitors

Mechanism

PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors), RNAi(RNA interference)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Homozygous familial hypercholesterolemiaHypercholesterolemiaPrimary Hyperlipidemia+ [13]

Inactive Indication-

Originator Organization

Alnylam Pharmaceuticals, Inc.

Active Organization

Novartis Pharmaceuticals Canada, Inc.

Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Australia Pty Ltd.

+ [7]

Inactive Organization

The Medicines Co.

Alnylam Pharmaceuticals, Inc.

Alcami Corp.

License Organization

National Health Service

The Medicines Co.

Alnylam Pharmaceuticals, Inc.

+ [5]

Drug Highest PhaseApproved

First Approval Date

European Union (09 Dec 2020),

Complex dyslipidemiaPrimary hypercholesterolemia

RegulationOrphan Drug (United States)

Structure/Sequence

Boost your research with our RNA technology data.

view full example data

Sequence Code 31593325

Source: *****

Sequence Code 31594604

Source: *****

Clinical Trials associated with Inclisiran sodium

NCT07803822

/ RecruitingPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Participants With Mixed Dyslipidemia and Inadequate Lipid Control

This is a multicenter, randomized, blinded, placebo-controlled Phase 2 study designed to preliminarily evaluate the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of MWX203 Injection alone or in combination with Inclisiran Sodium Injection in participants with mixed dyslipidemia who have inadequate lipid control despite stable statin therapy.
The study includes 5 parallel arms with a planned enrollment of 216 Chinese participants. The study drug is administered subcutaneously once every 12 weeks for a total of 2 doses. The double-blind treatment period lasts 36 weeks, and participants whose lipid levels do not return to baseline will enter a 12-week extended follow-up period. The primary endpoint is the percentage change in serum triglyceride (TG) level from baseline at Week 24.

Start Date25 Sep 2026

Sponsor / Collaborator

Shanghai Minwei Biotechnology Co., Ltd

NCT07799779

/ Not yet recruitingPhase 4IIT

Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)

This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.
Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.

Start Date01 Sep 2026

Sponsor / Collaborator

Seoul National University Bundang Hospital

[+2]

NCT07684469

/ Not yet recruitingPhase 4

Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia

This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).

Start Date30 Jun 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Inclisiran sodium

100 Translational Medicine associated with Inclisiran sodium

100 Patents (Medical) associated with Inclisiran sodium

314

Literatures (Medical) associated with Inclisiran sodium

01 Oct 2026·AMERICAN HEART JOURNAL

Design of VICTORION-2 Prevent: A randomized double-blind, placebo-controlled trial, assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease

Article

Author: Steg, Philippe Gabriel ; Menon, Venu ; Lesogor, Anastasia ; Bhatt, Deepak L ; Jukema, Johan Wouter ; Mena-Madrazo, Jorge ; Mehran, Roxana ; O'Donoghue, Fintan ; Liu, Karen ; Szarek, Michael ; Goodman, Shaun G ; Shao, Qing ; Martens, Pieter ; Stratz, Christian ; Zirlik, Andreas

RATIONALE:

Inclisiran is a small interfering ribonucleic acid targeting hepatic proprotein convertase subtilisin/kexin type 9 messenger RNA, that effectively reduces low-density lipoprotein cholesterol (LDL-C) levels. The effect of inclisiran on cardiovascular (CV) outcomes has not been formally tested.

METHODS:

VICTORION-2 Prevent (NCT05030428) is an ongoing, Phase 3 randomized, double-blind, placebo-controlled, international trial assessing the efficacy and safety of inclisiran in preventing CV events in patients with established atherosclerotic cardiovascular disease (ASCVD) receiving high-intensity statin therapy. Patients with established ASCVD (history of myocardial infarction [MI], ischemic stroke, or symptomatic peripheral artery disease), and fasting plasma LDL-C ≥ 1.8 mmol/L (70 mg/dL) despite high-intensity statin therapy (≥ 20 mg rosuvastatin or ≥ 40 mg atorvastatin daily) will be enrolled. Patients will be treated with inclisiran sodium 300 mg or placebo, administered subcutaneously at Day 1, Day 90, and every 6 months thereafter. The primary outcome will include time to first occurrence of 3-point major adverse CV events (3P-MACE; composite of CV death, MI, or ischemic stroke). Secondary outcomes will include time to occurrence of CV death, time to first occurrence of 4P-MACE (composite of 3P-MACE and urgent revascularization), and major adverse limb event (all adjudicated outcomes), time to occurrence of all-cause death, and long-term safety of inclisiran. Safety will be monitored using a selective safety data collection strategy.

CONCLUSION:

VICTORION-2 Prevent will provide robust data on CV benefits and safety of inclisiran in patients with established ASCVD and not at guideline-recommended LDL-C goals despite high-intensity statin treatment.

CLINICAL TRIAL REGISTRATION:

https://clinicaltrials.gov/study/NCT05030428.

01 Sep 2026·SEMINARS IN THROMBOSIS AND HEMOSTASIS

Clinical Response to Elevated Lipoprotein(a): Practical Approach for Risk Management in the Absence of Targeted Therapies

Review

Author: Lippi, Giuseppe ; Sanchis-Gomar, Fabian

Abstract:

Lipoprotein(a) (Lp(a)) is a genetically determined, lifelong cardiovascular risk factor strongly associated with atherosclerotic cardiovascular disease (ASCVD) despite optimal low-density lipoprotein cholesterol (LDL-C) lowering. The current management is challenged by the absence of outcome-proven Lp(a)-specific therapies. Statins, ezetimibe, bempedoic acid, and lifestyle interventions have little or no effect on Lp(a). Statins may modestly raise levels; niacin is now contraindicated as it has not been shown to reduce cardiovascular or all-cause mortality, while PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) inhibitors and inclisiran reduce Lp(a) concentrations by approximately 20 to 30%, though this effect remains secondary to their LDL-C-lowering effect. The only U.S. Food and Drug Administration (FDA)-approved therapy specifically addressing Lp(a) is lipoprotein apheresis, which reduces Lp(a) levels by 60 to 75%, but is restricted to specific patient populations due to invasiveness, high cost, and limited availability. Future promise lies in RNA-based therapies, including antisense oligonucleotides (pelacarsen) and small-interfering RNAs (olpasiran, lepodisiran, SLN360), which achieve 80 to 95% sustained Lp(a) reductions. Large outcome trials will determine whether this biochemical efficacy translates into tangible clinical benefits. Current guidelines now recommend one-time lifetime Lp(a) measurement, treating ≥125 nmol/L (≥50 mg/dL) as a risk-enhancing factor. High or extreme elevations, especially with ASCVD, mandate aggressive LDL-C lowering, optimization of modifiable risk factors, family cascade screening, and apheresis or referral to RNA-therapy trials in select cases. Thus, while therapeutic options remain limited, systematic measurement and risk stratification are ethically justified to prepare for the imminent arrival of Lp(a)-targeted therapies.

01 Aug 2026·CARDIOVASCULAR DRUGS AND THERAPY

The 2025 ESC/EAS Dyslipidaemia Focused Update: Clinical Interpretation and Practical Implications

Review

Author: Bonanni, Luca ; Ferri, Nicola ; Cutolo, Ada

The 2025 ESC/EAS Dyslipidaemia Focused Update provides a targeted revision of the 2019 guidelines, integrating newly available evidence with the potential to influence clinical decision-making before the next full update. While LDL-C treatment targets remain unchanged, the document reshapes how they should be achieved, emphasizing faster therapeutic intensification, broader use of combination therapy and improved risk stratification with SCORE2/SCORE2-OP, lipoprotein(a) [Lp(a)] and coronary artery calcium (CAC) scoring. New evidence supporting bempedoic acid, inclisiran and evinacumab expands the therapeutic armamentarium, particularly for patients at high, very high and extreme cardiovascular risk or those with statin intolerance. In the acute coronary syndrome (ACS) setting, the update reinforces a more proactive, early-intensification approach. Overall, the Focused Update refines the operational framework of LDL-C management, promoting earlier, more personalized and more sustained lipid lowering to reduce cumulative atherosclerotic exposure.

338

News (Medical) associated with Inclisiran sodium

31 Aug 2026

·firstwordpharma.com

ESC2026: Repatha tied to 20% lower death risk before first heart attack, stroke

A new analysis of Amgen's Phase III VESALIUS-CV trial has found that its cholesterol-lowering drug Repatha (evolocumab) nominally reduced the risk of death by 20% in high-risk patients who had not previously experienced a heart attack or stroke.According to Amgen, that makes Repatha the first PCSK9 inhibitor shown to lower overall mortality risk, including risk for heart-related death, in a Phase III trial of primary prevention patients. Findings from the pre-specified secondary analysis of VESALIUS-CV were presented at the European Society of Cardiology (ESC) congress, and published simultaneously in Circulation on Monday."For people at high risk of a heart attack or stroke, lowering LDL-C or 'bad' cholesterol with Repatha may do more than help prevent these events; it may also reduce the risk of dying from heart disease and its serious consequences," said Jay Bradner, EVP, R&D, AI and data at Amgen.Case for earlier treatmentVESALIUS-CV enrolled more than 12,000 adults at high cardiovascular (CV) risk — either those with known atherosclerotic disease or high-risk diabetes — but who had no history of heart attack or stroke. Participants also had elevated cholesterol markers and were treated with the highest tolerated dose of statin and/or ezetimibe.Over a median 4.6 years of follow-up, nearly 8% of patients died; 36% were from CV causes, 51% from non-CV causes, and the rest from causes that couldn't be determined. Patients taking Repatha were significantly less likely to die from any cause than those on placebo (7.9% vs. 9.7% over the follow-up period; HR 0.80, p=0.0005). The mortality benefit emerged after about 1.5 years of treatment and continued through follow-up.The mortality findings build on the main VESALIUS-CV results, which were published in NEJM last year. In that analysis, Repatha reduced the risk of a composite of coronary heart disease death, heart attack or ischaemic stroke by 25%, while a broader composite including ischaemia-driven revascularisation fell 19% (see – Spotlight On: Amgen's Repatha posts big primary prevention win – but big enough?).Amgen said additional analyses presented at ESC showed reductions in first, subsequent and total CV events, with a reduction in first heart attacks being seen as early as six months after treatment with Repatha started. The risk reduction was mainly due to fewer heart attacks caused by ruptured atherosclerotic plaques, and fewer larger infarctions."The totality of these data is practice-changing and reinforces the importance of identifying high-risk patients early and lowering LDL-C aggressively and consistently with Repatha," Bradner said.Push into primary preventionMonday's findings could bolster Amgen's push to move intensive lowering of LDL-C earlier in the CV disease pathway, as the company looks to extend the commercial runway of a drug that was first approved more than a decade ago.That strategy likely matters even more now with the recent FDA approval of Merck & Co.'s Lipfendra (enlicitide), the first once-daily oral PCSK9 inhibitor, which offers patients a pill-based alternative to injectable therapies (see – Spotlight On: Updated Physician Views poll data shows particularly strong support for Merck & Co.'s Lipfendra from US cardiologists and Physician Views Results: Novartis' Leqvio well positioned, but oral PCSK9 threat is real).Repatha, which generated about $3 billion in sales last year, had its label expanded in 2017 to include secondary prevention.

Phase 3Clinical ResultDrug ApprovalAHA

20 Aug 2026

·www.biospace.com

Scribe’s early-stage IPO standout defies biotech’s derisking trend

iStock, jittawit.21 Scribe Therapeutics’ one-time epigenetic treatment is designed to slash the adherence burden of chronic cholesterol-lowering therapies while sidestepping the irreversibility of gene editing. Scribe Therapeutics is testing whether investors will embrace an earlier-stage bet in a market that favors derisked IPO stories. But Scribe’s outlier status goes far beyond the fact that the biotech filed to go public around the same time it was heading into the clinic. Less than a month since debuting and raising an upsized $150 million, Scribe—the only public company with an epigenetic silencer in the clinic—has seen its stock rise 43% from its first-day price of $21.50, resting at $31.05 by close on Wednesday. In comparison, biotech’s industry stock index, known as the XBI, has risen 12% over the last month. Beyond bucking the trend of late-stage biotechs with derisked assets debuting, the CRISPR-focused company is “a story that very quickly will be validated one way or the other, meaning they’re going to have a data update early next year,” Jack Bannister, senior managing director of equity capital markets at Leerink Partners, told BioSpace . Leerink served as one of the book-running managers for Scribe’s IPO. The biotech has designed a single dose of its main asset STX-1150 to lower LDL cholesterol (LDL-C), often known as “bad” cholesterol. The asset leverages epigenetic silencing, as opposed to gene editing, in hopes of significantly lowering the risk of atherosclerotic cardiovascular disease (ASCVD) without permanently changing the DNA sequence. STX-1150 targets PCSK9 and is currently entering Phase 1 trials in Australia, with interim results in patients with high LDL-C set to read out in the first half of next year. Beyond a clean safety profile, Leerink analysts hope STX-1150 can reduce LDL-C by 50% or more, which would translate to significantly improved adherence-adjusted efficacy compared to approved drugs such as Amgen’s Repatha, Novartis’ and Alnylam’s Leqvio or Merck’s newly approved Lipfendra , according to an Aug. 18 note. “We believe a positive readout [for Scribe] would drive a meaningful value inflection,” Leerink wrote. The analysts pointed to Eli Lilly’s $1 billion upfront acquisition of gene editor Verve Therapeutics last year, which came on the heels of Phase 1b safety and LDL-C lowering results among only 14 patients. “It’s the kind of dataset where investors should know quickly whether the drug’s working or not, and so it could be a material value inflection point right out of the gate,” Bannister said about Scribe, comparing the situation to the many biotechs that start with healthy volunteers or are just looking for safety signals early on. “That’s not Scribe. At Scribe, you should have a pretty good sense early and quickly whether it’s worth something or not.” Leerink believes STX-1150, which is delivered via lipid nanoparticle, could offer similar efficacy to current PCSK9-targeting injections or daily pills, while also improving convenience. The candidate is also designed to be safer than gene editors since no permanent genetic changes are made. Scribe also differs from other newly public biotechs in fundraise size. The valuation of the IPO is considerably lower, especially compared to record-breakers Kailera Therapeutics’ $625 million debut and Parabilis Medicines’ subsequent $670 million IPO . That’s by design, Bannister explained. “It was important for us to find a price that was attractive to not just existing investors but new investors as well,” he said, adding that they wanted to “price the deal to trade well.” The strategy seems to be paying off. While Scribe hasn’t been on the market as long as either Kailera or Parabilis, the biotech’s stock has risen more than the other two, with Kailera at a 31.4% loss from its first-day price and Parabilis up 24.5% as of Aug. 18, according to BioSpace ’s performance tracker . “Valuation matters. Companies who have leaned in too hard on value and tried to push at too high of a price haven’t traded as well this year,” Bannister said. “Those who have been much more conservative on price have traded well. It’s not a coincidence, right?” IPO Hair loss biotech Veradermics, up 656% since its IPO, credits the obesity boom After debuting on the public markets with $256.3 million and raking in an additional $472 million , Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels. July 6, 2026 · 5 min read · Gabrielle Masson Read more Leerink believes Scribe will outperform market expectations, forecasting a $37 price target, according to the analyst note. The California-based biotech was co-created by four CRISPR pioneers, including CEO Benjamin Oakes and Nobel Prize winner Jennifer Doudna. Beyond main asset STX-1150, Scribe has also built a gene editing platform called X-Editor that underpins two potential pipeline candidates: STX-1200 for Lp(a) and STX-1400 for severe hypertriglyceridemia—the other two lipid drivers of ASCVD. This platform has already attracted deals from two major pharmas, Sanofi and Eli Lilly —something Leerink dubs “impressive external validation.” Both pharma companies invested in Scribe’s IPO as well. The biotech expects its cash runway to carry it into the first half of 2029.

IPOPhase 1AcquisitionGene Therapy

19 Aug 2026

·www.biospace.com

Novartis data at ESC Congress 2026 reinforce cardiovascular leadership and showcase progress in next-generation therapies

Late-breaking Phase IV VICTORION-CHALLENGE data will evaluate Leqvio ® (inclisiran) vs. bempedoic acid in achieving LDL-C goals New AZALEA-TIMI 71 analyses will further characterize the bleeding pro abelacimab in patients with atrial fibrillation, including recurrent bleeding events Lp(a)CCELERATE, in partnership with European Atherosclerosis Society (EAS), will explore strategies to help advance guideline-recommended Lp(a) testing in clinical practice Basel, August 19, 2026 – Novartis will present data from 10 abstracts across its cardiovascular portfolio at the 2026 European Society of Cardiology (ESC) Congress, reinforcing its leadership in addressing cardiovascular risk. “The data we are presenting at this year’s ESC Congress underscore our commitment to advancing cardiovascular science for patients who remain at risk despite current treatment,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal and Metabolic Development, Novartis. “From foundational medicines Leqvio and Entresto to promising investigational therapies, our portfolio reflects our focus on addressing persistent challenges in cardiovascular care.” Key abstracts accepted by ESC include: Medicine/Disease Abstract Title Presentation Details Leqvio ® Head-to-head comparison of inclisiran vs bempedoic acid for LDL C lowering in patients with high and very high cardiovascular risk: Results from the phase 4 VICTORION-CHALLENGE trial Tripoli (Hall B1) Late-Breaking Oral Presentation August 31, 08:15-08:30 CEST Leqvio ® An inclisiran-based treatment strategy reduces the need for therapy escalation to achieve low-density lipoprotein cholesterol goals: Exploratory findings from the VICTORION-Difference trial Exchange Circle 3 (Research Gateway – Hall A1) ePoster August 29, 09:15-10:00 CEST Abelacimab Effect of abelacimab vs. rivaroxaban on total bleeding events in patients with atrial fibrillation: an analysis from AZALEA-TIMI71 Science Box 2 (Research Gateway – Hall A1) Oral Presentation August 29, 09:30-10:30 CEST Lipoprotein (a) [Lp(a)] Mobilizing core and country-tailored implementation strategies to accelerate Lipoprotein(a) testing across Europe: findings from the Lp(a)CCELERATE contextual analysis Exchange Circle 6 (Research Gateway – Hall A1) ePoster August 29, 16:15-17:00 CEST Entresto ® Effects of sacubitril/valsartan versus enalapril on NT-proBNP and hs-troponin T in patients with heart failure due to Chagas disease: insights from the PARACHUTE-HF trial Station 5 (Research Gateway – Hall A1) ePoster August 31, 09:15-10:00 CEST Pacibekitug TRANQUILITY: Efficacy of monthly and quarterly dosing of pacibekitug (IL-6 ligand mAb) targeting inflammation in CKD with high cardiovascular risk Munich (Main Auditorium-Hall B3) Hot Line August 29, 08:45-09:00 CEST About Novartis in Cardiovascular Disease At Novartis, we're redefining cardiovascular care, shifting toward earlier action, expanding how we understand and treat cardiovascular disease, and pushing the boundaries of what's possible so more people can live longer, healthier lives. Building on our 40-year legacy, we're committed to shaping what's next in cardiovascular care through bold science and a diverse, industry-leading pipeline. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

AHAPhase 3Clinical Result

100 Deals associated with Inclisiran sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D11931 D12293	Inclisiran sodium	C10AX	DB14901

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Homozygous familial hypercholesterolemia	United States	Novartis Pharmaceuticals Corp.	12 Feb 2026
Hypercholesterolemia	Japan	Novartis Pharma KK	25 Sep 2023
Primary Hyperlipidemia	United States	Novartis Pharmaceuticals Corp.	07 Jul 2023
Atherosclerosis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	14 Sep 2021
Heterozygous familial hypercholesterolemia	Canada	Novartis Pharmaceuticals Canada, Inc.	26 Jul 2021
Hypercholesterolemia, Familial	Canada	Novartis Pharmaceuticals Canada, Inc.	26 Jul 2021
Complex dyslipidemia	European Union	Novartis Europharm Ltd.	09 Dec 2020
Complex dyslipidemia	Iceland	Novartis Europharm Ltd.	09 Dec 2020
Complex dyslipidemia	Liechtenstein	Novartis Europharm Ltd.	09 Dec 2020
Complex dyslipidemia	Norway	Novartis Europharm Ltd.	09 Dec 2020
Primary hypercholesterolemia	European Union	Novartis Europharm Ltd.	09 Dec 2020
Primary hypercholesterolemia	Iceland	Novartis Europharm Ltd.	09 Dec 2020
Primary hypercholesterolemia	Liechtenstein	Novartis Europharm Ltd.	09 Dec 2020
Primary hypercholesterolemia	Norway	Novartis Europharm Ltd.	09 Dec 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Coronary Syndrome	Phase 3	China	Novartis Pharmaceuticals Australia Pty Ltd.	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Japan	Novartis Pharma AG	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Japan	Corden Pharma SpA	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Japan	Novartis Pharmaceutical Manufacturing GmbH	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Japan	Novartis Pharmaceuticals Australia Pty Ltd.	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Argentina	Novartis Pharma AG	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Argentina	Corden Pharma SpA	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Argentina	Novartis Pharmaceutical Manufacturing GmbH	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Argentina	Novartis Pharmaceuticals Australia Pty Ltd.	03 Oct 2025
Acute Coronary Syndrome	Phase 3	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	03 Oct 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05192941 (VICTORION-Difference \| V-DIFFERENCE, CTgov)	Phase 4	Heterozygous familial hypercholesterolemia \| Hypercholesterolemia	1,770	Inclisiran Sodium (Inclisiran)	qtbaxtgslg = blxxyediep sgkjldzddi (wgrzypgcwn, ldojxdonhn - qidwzoudhr) View more	-	14 Apr 2026
				Placebo (Placebo)	qtbaxtgslg = momhyajhwx sgkjldzddi (wgrzypgcwn, wbnkcumxwo - cqeaubzeen) View more
NCT05192941 (VICTORION-Difference \| V-DIFFERENCE, NEWS) Manual	Phase 4	Hypercholesterolemia	1,770	Inclisiran sodium 300 mg	fnntfbmheo(enlgmsdmvq) = yrsohffyrw vtvzpdutmn (phewdyhemt ) Met View more	Positive	30 Aug 2025
				Placebo	fnntfbmheo(enlgmsdmvq) = aikfatnpms vtvzpdutmn (phewdyhemt ) Met View more
NCT05763875 (V-MONO \| VICTORION-Mono, CTgov)	Phase 3	Primary hypercholesterolemia	350	Matching Placebo for Ezetimibe+Inclisiran (Inclisiran)	wgnjwxrwtu(jbjyiamkua) = kpywpumfkc stqatsnqlg (mcoisgabsi, aewupsjggu - xmppahqlyq) View more	-	13 Aug 2025
				Matching Placebo for Inclisiran+Ezetimibe (Ezetimibe)	wgnjwxrwtu(jbjyiamkua) = vgojsmmqlx stqatsnqlg (mcoisgabsi, ooybhmsqlm - oxxguwvlao) View more
NCT05763875 (VICTORION-Mono, Pubmed) Manual	Phase 3	Hypercholesterolemia	350	Inclisiran	rgiznldkaj(uwaetwgzxb) = hqavzdfxjb yxhplyvuwm (vamuxqayko )	Positive	01 Jul 2025
				Ezetimibe	rgiznldkaj(uwaetwgzxb) = rlekfaiazx yxhplyvuwm (vamuxqayko )
NCT04652726 (ORION-16, CTgov)	Phase 3	Heterozygous familial hypercholesterolemia	141	Inclisiran sodium (Part 1- Inclisiran)	hxszlhhltv(hdooqbrjtm) = uggfhahjtk fjsfuopkye (yissmjbiox, exmxauatso - emyuwyryar) View more	-	10 Jun 2025
				Placebo (Part 1 - Placebo)	hxszlhhltv(hdooqbrjtm) = cszhjyvith fjsfuopkye (yissmjbiox, hxbzmkzari - ihpzsvcwch) View more
NCT04659863 (ORION-13, CTgov)	Phase 3	Homozygous familial hypercholesterolemia	13	Placebo (Part 1 - Placebo)	sjpwlibqyr(xeuuctdoub) = amwkynexne hetxjqjfzp (awpnqgotac, 30.52) View more	-	31 May 2025
				Inclisiran (Part 2 - Inclisiran (Total))	mfdfeiuknd(cykjyzbglu) = hbmtjjgkpp embggmgwjf (kqcoaqbypj, 25.28) View more
NCT05888103 (V-Mono China, CTgov)	Phase 3	Dyslipidemias \| Primary hypercholesterolemia	207	Matching Placebo for Inclisiran+Inclisiran (Inclisiran - Inclisiran)	ualixxivom(kmpkjwrxxg) = zcicgomznx ulfbjtolgc (jtjpdzlayv, dhddnakpol - exjptnvbdc) View more	-	20 Apr 2025
				Matching Placebo for Inclisiran+Inclisiran (Placebo- Inclisiran)	ualixxivom(kmpkjwrxxg) = expavkvtuu ulfbjtolgc (jtjpdzlayv, esjhljjmnm - tidwoyptah) View more
ORION-18 (NEWS) Manual	Phase 3	Atherosclerosis	232	英克司兰钠 300 mg	obdmlidgoo(cjyqhxanqv) = pbsepqbskk jhgpeeyuqf (dwbgfpbskm ) View more	Positive	06 Mar 2025
				安慰剂	obdmlidgoo(cjyqhxanqv) = kwhqpeafnj jhgpeeyuqf (dwbgfpbskm )
NCT03814187 (ORION-8, Pubmed \| Cardiovasc Res)	Phase 2/3	Hyper LDL cholesterolaemia \| Homozygous familial hypercholesterolemia \| Heterozygous familial hypercholesterolemia	3,274	Inclisiran	tgdnsypcoj(zxzwyupjky) = 5.9% of inclisiran-treated patients rbvezqxjqa (cmwkiozcdr )	Positive	14 Oct 2024
ESC2024	Not Applicable	-	-	Inclisiran	alxxuxkmee(rnmuctlymu) = jperionqeg iefznlyhms (wmrataddne ) View more	-	31 Aug 2024

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