Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

Start Date01 Jun 2025

Sponsor / Collaborator

Asan Medical Center

NCT06933459

/ Not yet recruitingPhase 1

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C714 Compared to C714R in Healthy Adult Volunteers

To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults

Start Date25 May 2025

Sponsor / Collaborator

Aju Pharm Co. Ltd.

KCT0010331

/ Not yet recruitingPhase 4IIT

Comparing the Moderate Intensity STatin with Ezetimibe COmbination TheraPy with High Intensity Statin Monotherapy on Coronary PLAQUE Stablization (STOP-PLAQUE trial)

Start Date31 Mar 2025

Sponsor / Collaborator

Korea University Anam Hospital

100 Clinical Results associated with Ezetimibe

100 Translational Medicine associated with Ezetimibe

100 Patents (Medical) associated with Ezetimibe

6,371

Literatures (Medical) associated with Ezetimibe

01 Aug 2025·INTERNATIONAL JOURNAL OF CARDIOLOGY

LDL-cholesterol levels and lipid lowering therapy in secondary prevention. Baseline data from the BRING-UP prospective registry

Article

Author: Abrignani, Maurizio Giuseppe ; Maffei, Simone ; Barbato, Emanuele ; Aloia, Antonio ; Alonzo, Alessandro ; Navazio, Alessandro ; Arca, Marcello ; Oliva, Fabrizio ; Calò, Leonardo ; La Rosa, Giuseppe ; Di Lenarda, Andrea ; Riccio, Carmine ; Temporelli, Pier Luigi ; Catapano, Alberico Luigi ; Calabrò, Paolo ; Bertoli, Daniele ; Pavan, Daniela ; Scicchitano, Pietro ; Aschieri, Daniela ; Fabbri, Gianna ; Carugo, Stefano ; Ceseri, Martina ; Fattirolli, Francesco ; Colivicchi, Furio ; Averna, Maurizio ; Di Fusco, Stefania Angela ; Maggioni, Aldo Pietro ; Gabrielli, Domenico ; Themistoclakis, Sakis ; Scelza, Nicola ; Gonzini, Lucio ; Gulizia, Michele Massimo ; Crisci, Vincenzo

AIMS:

To narrow the gap between guidelines recommendation for secondary cardiovascular prevention and clinical practice, we designed a national project based on educational programs and patient data collection.

METHODS:

BRING-UP Prevention is an observational, prospective, multicentre study on patients with an atherothrombotic event enrolled in 2 phases: an educational intervention followed by two 3-months data collection, followed by 6 and 12-month follow-up, when the primary, secondary and exploratory endpoints will be evaluated. Clinical characteristics, treatments and target achievement for LDL cholesterol and other modifiable risk factors at baseline are reported in this manuscript.

RESULTS:

From September 2023 to February 2024, 189 cardiology centers included 4790 patients, 2500 hospitalized, and 2290 managed as outpatients. Of the 4790 patients, 98 % had CAD, 6.1 % CVD, and 6.9 % PAD. Mean age was 67 ± 11 years, 20 % were females. Patients with LDL-C levels <55 mg/dL were 32.6 %. Patients at target for blood pressure were 39.2 %. Diabetic patients were 27.5 %, HbA1c <7 % was reported in 43.5 % of them. Statins prescription increased from 69 % at entry to 96 % at discharge/end of visit. In 74.5 % of patients, statins were prescribed in combination with ezetimibe. PCSK9-i or inclisiran were prescribed in a low rate of patients.

CONCLUSION:

These data show that a low percentage of patients was at goal for LDL-C level and blood pressure. The 6-month follow-up visit will allow us to evaluate the changes in modifiable risk factors.

01 Aug 2025·INTERNATIONAL JOURNAL OF CARDIOLOGY

Impact of a personalized, strike early and strong approach on non-HDL-cholesterol levels and outcome in patients with acute myocardial infarction

Article

Author: Marengo, Alessandra ; D'Amario, Domenico ; Grisafi, Leonardo ; Patti, Giuseppe ; Solli, Martina ; Mennuni, Marco ; Bosco, Manuel ; Cumitini, Luca

AIMS:

We retrospectively evaluated the impact on non-HDL-cholesterol (non-HDL-C) levels of the systematic introduction in our institution of an individualized, pre-defined, strike early and strong (SES) strategy for lipid-lowering therapy (LLT) in patients with acute myocardial infarction (MI).

METHODS:

We analyzed data from 500 consecutive patients admitted across three periods: Period A (N = 198, January-June 2019), when the non-HDL-C goal was <100 mg/dL and a stepwise LLT approach was indicated; Period B (N = 180, January-June 2021), when the non-HDL-C goal was <85 mg/dL and a stepwise approach was recommended; Period C (N = 122, January-June 2023), when the SES protocol was introduced. Primary endpoints were the percentage of patients reaching the non- HDL-C goal during follow-up and the incidence of major adverse cardiovascular events (MACE) at one year.

RESULTS:

Compared to the other periods, the prevalence of prescription at discharge of potent statins, alone or in combination with ezetimibe, and PCSK9 inhibitors was greater in Period C. The achievement of the non-HDL-C goal in Period C was higher (87 % vs 67 % and 58 % in Periods A and B, respectively; p < 0.001). This achievement was associated with a lower occurrence of MACE (7 % vs. 13 % in patients not at target; log-rank p = 0.027). MACE incidence was the lowest in patients with early and sustained non-HDL-C < 85 mg/dL during follow-up.

CONCLUSION:

The systematic introduction of an individualized, SES approach for LLT in patients with acute MI led to higher achievement of the non-HDL-C goal and this translated into a lower risk of MACE.

01 Jun 2025·CLINICAL THERAPEUTICS

A Phase III Randomized, Double-Blind, Active-Controlled, Multicenter Study on the Efficacy and Safety of Ezetimibe/Atorvastatin/Amlodipine Combination in Patients With Comorbid Primary Hypercholesterolemia and Essential Hypertension

Article

Author: Lee, Chan Joo ; Choi, Jung Hyun ; Han, Seung Hwan ; Choi, Jin-Oh ; Shin, Jinho ; Kim, Eung Ju ; Yoon, Young Won ; Kim, Kye Hun ; Hwang, Byung-Hee ; Sung, Jung-Hoon ; Choi, Ji Yong ; Lee, Pil Hyung ; Kang, Seok-Min

PURPOSE:

This study aimed to evaluate the efficacy and safety of triple combination of ezetimibe (Eze)/atorvastatin (Ato) 10/40 mg + amlodipine (Aml) 10 mg therapy for lowering the low-density lipoprotein cholesterol (LDL-C) and blood pressure compared with either Eze/Ato 10/40 mg or Aml 10 mg therapies in patients with comorbid primary hypercholesterolemia and essential hypertension.

METHODS:

This was a randomized, multicenter, double-blind, active-controlled, Phase III clinical trial. Participants underwent a wash-out period (2 weeks for nonfibrate medications, 6 weeks for fibrates) followed by 4 weeks of therapeutic lifestyle changes. Subsequently, 109 participants were randomly assigned to 3 groups: (1) Eze/Ato 10/40 mg + Aml 10 mg, (2) Eze/Ato 10/40 mg, and (3) Aml 10 mg. The coprimary end points were percentage change in LDL-C and change in mean sitting systolic blood pressure (SBP) compared with baseline at week 8.

FINDINGS:

A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups. After 8 weeks of treatment, the least-square (LS) mean (SE) of percent change from baseline in LDL-C was -57.95% (3.52%) for the Eze/Ato 10/40 mg + Aml 10 mg group and 8.93% (3.54%) for the Aml 10 mg group. The LS mean difference (SE) between these 2 groups was statistically significant at -66.88 (4.95) (95% CI, -76.77% to -56.99%) (P < 0.0001). Furthermore, at week 8, the LS mean (SE) change in mean sitting SBP between the Eze/Ato 10/40 mg + Aml 10 mg group and the Eze/Ato 10/40 mg group was -19.24 (2.42) mm Hg and -4.43 (2.56) mm Hg, respectively. The LS mean difference (SE) between the 2 groups was statistically significant -14.81 (3.53) (95% CI, -21.87 to -7.74) mm Hg (P < 0.0001). No serious adverse drug reactions occurred in any of the study groups.

IMPLICATIONS:

Triple combination therapy with Eze/Ato + Aml has effectively reduced the LDL-C and SBP independently, compared with either Eze/Ato or Aml therapies over 8 weeks of treatment period. In terms of safety, there were no significant differences among the 3 treatment groups. This research lays the groundwork for the development of a triple fixed-dose combination in the future, which could improve patient convenience and adherence by reducing pill burden. Clinical Research Information Service (CRIS), Republic of Korea: KCT0006283.

203

News (Medical) associated with Ezetimibe

28 May 2025

·www.einpresswire.com

SCYNEXIS Resumes Patient Dosing in Phase 3 MARIO Study

First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold Resumption of dosing in this study triggers a $10M milestone payment from GSK plus an additional $20M milestone due in six months; as previously disclosed GSK disputes these milestone payments, and SCYNEXIS vigorously disagrees with their position JERSEY CITY, N.J., May 28, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection. The study had been on hold due to concerns about potential cross-contamination in light of draft U.S. Food and Drug Administration (FDA) guidance regarding manufacturing a non-antibiotic beta-lactam (ezetimibe) at the same site as ibrexafungerp. The study has resumed following the manufacture of new clinical supplies at another site and the lifting of the clinical hold by the FDA. If the study is successful and approval for this indication is granted by the FDA, it will give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the Mechanism of Action (glucan synthase inhibition) of the IV-only echinocandins, which are the gold standard for treatment of invasive Candida infections. SCYNEXIS’s position is that the dosing of this first new patient triggers a $10 million payment from partner GSK, with another $20 million payment to be triggered by the six-month anniversary of dosing. As previously disclosed, there is a disagreement between SCYNEXIS and GSK regarding the resumption of the MARIO Study and GSK’s responsibility for paying these milestones. SCYNEXIS is working to resolve the disagreement. “We are pleased to announce the dosing of the first new patient in the Phase 3 MARIO study following the lifting of the clinical hold by the FDA in April,” said David Angulo, M.D., President and Chief Executive Officer. “The rapid resumption of patient enrollment, just a few days after the investigational sites were re-activated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.” SCYNEXIS is thankful to the investigators participating in this trial for their support and patience during the clinical hold period, and for their continued commitment to the successful completion of this important study, which has already enrolled approximately 25% of the projected patients. “I’m happy to see this important study restarted, and glad that we have been able to contribute by enrolling a new patient,” said Barbara D. Alexander, MD, MHS, FIDSA Professor of Medicine and Pathology at Duke University and the Director of the Transplant Infectious Diseases Service. “We need additional treatment options for patients with invasive fungal diseases, and we are looking forward to the completion of this study evaluating oral ibrexafungerp in this area of significant unmet need.” “There is substantial need for new treatments for invasive candidiasis, particularly for Candida strains resistant to the currently approved antifungals,” added Dr. Luis Ostrosky-Zeichner, MD, Professor of Medicine and Epidemiology and Chief at the Division of Infectious Diseases of the McGovern Medical School (UTHealth Houston). “Ibrexafungerp could play an important role in improving the outcome of patients with these life-threating infections, and I am glad to see this important study reinitiated in our institution.” About Triterpenoid Antifungals Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage development for invasive candidiasis. The next generation fungerp, SCY-247, is currently in the late stages of a Phase 1 clinical study. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in clinical, pre- clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com . CONTACT : Investor Relations Irina Koffler LifeSci Advisors Tel: (646) 970-4681 ikoffler@lifesciadvisors.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalQualified Infectious Disease Product

27 May 2025

·www.einpresswire.com

Junshi Biosciences Announces Ongericimab’s sNDA Approval in China

SHANGHAI, May 27, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (the “NMPA”) has approved two supplemental new drug applications for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA (君适达 ® )) for: 1) adult patients with heterozygous familial hypercholesterolemia (“HeFH”); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated. Ongericimab has become China’s first domestic PCSK9-targeted drug approved for statin-intolerant patients. According to the Chinese Guidelines for Lipid Management (2023), cardiovascular disease is the leading cause of death among both urban and rural residents in China, with atherosclerotic cardiovascular disease (“ASCVD”) being the predominant subtype. The rise of low-density lipoprotein cholesterol (“LDL-C”) levels is a major cause of ASCVD. Lowering LDL-C levels can significantly decrease the incidence of ASCVD and risk of death. HeFH is a common type of familial hypercholesterolemia with an estimated prevalence of 1:250 ~ 1:200, and its main clinical features are significantly elevated LDL-C and early onset of coronary artery disease. Compared to patients with non-familial hypercholesterolemia, patients with HeFH exhibit higher baseline LDL-C levels and lower target levels for control recommended by the guidelines. Failure to achieve target LDL-C levels after treatments such as statins will result in patients being at high cardiovascular risk. In addition, despite statins currently being the cornerstone of lipid-lowering treatment, approximately 9.1% of patients clinically exhibit statin intolerance, with a higher proportion observed in Asian populations. Discontinuation of statins or the use of only tolerable doses in patients with statin intolerance may lead to suboptimal LDL-C levels, thereby failing to effectively reduce the patient’s ASCVD risk. As a new lipid-lowering drug that effectively reduces LDL-C levels, PCSK9 inhibitor has been recommended in the guidelines for the management of lipids both in China and overseas and is widely recognized by clinicians. The significant lipid-lowering effects of ongericimab have been demonstrated in multiple phase 3 clinical studies, and ongericimab was approved by the NMPA for the treatment of adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia in October 2024. The approval of the two supplemental new drug applications are mainly based on two registered clinical trials—JS002-005 (NCT05325203) and JS002-007 (NCT05621070). JS002-005 is a randomized, double-blind, placebo-controlled Phase 3 clinical study in adult patients with HeFH. JS002-005 was led by Professor Changsheng MA and Professor Jie LIN from Beijing Anzhen Hospital affiliated to Capital Medical University as the principal investigators. A total of 135 patients with HeFH were enrolled. This study is the first Phase 3 clinical study evaluating an anti-PCSK9 monoclonal antibody in Chinese patients diagnosed with HeFH (DLCN>8). The latest data on JS002-005 has been published in full in Atherosclerosis . The results showed that, compared with placebo, the ongericimab subcutaneous injection (150 mg every 2 weeks (Q2W) or 450 mg every 4 weeks (Q4W)) significantly reduced LDL-C levels by 69.4% and 80.6% (p<0.0001), respectively, for a 24-week treatment, with steady reduction during the treatment. At the same time, ongericimab also demonstrated significant improvements in other lipid parameters. Non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC), and lipoprotein (a) (“Lp(a)”) levels all markedly decreased from baseline. Notably, Lp(a) levels decreased by 50% from baseline. The overall safety profile was favorable, with the incidence of treatment-emergent adverse events (TEAEs) being comparable to that of the placebo group. JS002-007 is a randomized, double-blind, placebo-controlled Phase 3 clinical study conducted in adult patients with primary hypercholesterolemia and mixed hyperlipidemia who are statin-intolerant. JS002-007 was led by Professor Yida TANG from Peking University Third Hospital as the principal investigator. This is the first Phase 3 clinical study of anti-PCSK9 monoclonal antibody in Chinese patients with primary hypercholesterolemia or mixed dyslipidemia who are statin-intolerant. The results will be published in an international academic journal shortly. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “As of now, ongericimab has received approval for three key indications, including heterozygous familial hypercholesterolemia, non-familial hypercholesterolemia or mixed dyslipidemia who are statin-intolerant or statins contraindicated. This achievement not only represents a remarkable breakthrough in cardiovascular therapy, it also means that Chinese patients with cardiovascular disease will have more treatment options. Moving forward, our focus will continue ‘In China’ as we address more unique needs of local patients. Through innovative drug discovery, we aim to tackle more therapeutic areas while accelerating the development of and access to novel treatments.” About Ongericimab Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody injection independently developed by Junshi Biosciences. It was approved for marketing by the NMPA in October 2024. To date, ongericimab has been approved for three indications in the Chinese mainland: 1) adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia; 2) adult patients with HeFH; 3) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated. The approved specifications are 150 mg (1 ml) in a single dose (pre-filled syringe), 150 mg (1 ml) in a single dose (pre-filled autosyringe). In October 2023, Junshi Biosciences signed an agreement with Chongqing Bochuang Pharmaceuticals Co., Ltd. (“Bochuang Pharmaceuticals”), pursuant to which the company granted Bochuang Pharmaceuticals an exclusive license to conduct research and development on, manufacture and commercialize ongericimab for the licensed purposes and within the Chinese Mainland. Bochuang Pharmaceuticals will be responsible for the subsequent commercialization of ongericimab in the Chinese Mainland and will make corresponding milestone payments and sales commissions to Junshi Biosciences. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI ® , and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global”. At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalClinical ResultLicense out/in

09 May 2025

·www.pharmaceutical-technology.com

HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines

In 2024, the medicines’ indications were expanded to include cardiovascular risk minimisation in individuals who are not to take recommended statin therapy. Credit: chayanuphol / Shutterstock. HLS Therapeutics has signed an agreement with Esperion Therapeutics for in-licensing and commercialising the oral cardiovascular medicines, Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) in Canada. HLS’s agreement with Esperion includes an upfront payment of $1m, another $1m upon Health Canada’s approval, customary royalties on future sales, and potential milestone payments related to pricing, reimbursement, and significant commercial sale goals. In addition, Esperion will obtain an upfront payment and be qualified for milestone payments of up to nearly $5m alongside tiered royalties on product sales. HLS plans to fund all upfront and milestone-based payments, as well as related launch expenses, via current cash reserves, negating the need for additional financing. The company also plans to utilise its existing commercial infrastructure, expecting no significant increase in operating costs. HLS is tasked with receiving approval for these medicines from Health Canada, which is anticipated by the end of this year. These medications are currently available in various European nations and the US. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The US Food and Drug Administration (FDA) initially approved the medicines in 2020 for cutting low-density lipoprotein cholesterol (LDL-C) levels. In 2024, their indications were expanded to include cardiovascular risk minimisation in individuals who are not to take recommended statin therapy. This decision was supported by data from the CLEAR Outcomes trial. In fourth quarter (Q4) of 2024, Esperion made new drug submissions to Health Canada for both medicines. The brand names for these drugs in Canada will be confirmed upon approval from the country’s regulator. HLS noted that more than half a million individuals in Canada could potentially benefit from these treatments, particularly those with elevated levels of LDL-C and those who are either statin intolerant or not meeting LDL-C goals in spite of statins and ezetimibe combination therapy. HLS Therapeutics CEO Craig Millian said: “We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease.”

Drug ApprovalLicense out/in

100 Deals associated with Ezetimibe

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KEGG	Wiki	ATC	Drug Bank
D01966	Ezetimibe	C10AX09	DB00973

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperlipidemias	United States	Organon & Co.	05 Jun 2008
Hypercholesterolemia	United States	Organon & Co.	23 May 2006
Cardiovascular Diseases	Australia	Organon Pharma Pty Ltd.	23 Jun 2003
Heterozygous familial hypercholesterolemia	Australia	Organon Pharma Pty Ltd.	23 Jun 2003
Homozygous familial hypercholesterolemia	United States	Organon & Co.	25 Oct 2002
Primary hypercholesterolemia	United States	Organon & Co.	25 Oct 2002
Sitosterolemia	United States	Organon & Co.	25 Oct 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Coronary Artery Disease	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Sep 2009
Diabetes Mellitus	Phase 3	-	Organon & Co.	01 Sep 2006
Angina, Stable	Phase 3	-	Organon & Co.	12 Jul 2005
Angina, Stable	Phase 3	-	Schering-Plough Corp.	12 Jul 2005
Angina, Unstable	Phase 3	-	Organon & Co.	12 Jul 2005
Angina, Unstable	Phase 3	-	Schering-Plough Corp.	12 Jul 2005
Hyperlipidemia, Familial Combined	Phase 3	-	Organon & Co.	01 Dec 2002
Hypertriglyceridemia	Phase 3	-	Organon & Co.	01 Dec 2002
Atherosclerosis	Phase 3	-	Organon & Co.	01 Jun 2002
Diabetes Mellitus, Type 2	Phase 3	-	Organon & Co.	01 Dec 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Cardiovascular Diseases	-	Statins + Ezetimibe	wlfjctdkbq(crmgoktfnq) = xsdwkjimhc wezpdrmnmq (ztdrcrxjca ) View more	Positive	20 Mar 2025
				Statins	-
NCT04826354 (SaveSAMS, Pubmed) Manual	Phase 4	Atherosclerosis	561	Moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 5 mg with ezetimibe 10 mg)	mpclgpptqc(zlqxeejkrs) = egrhdmltjz uzjwhpskie (kanpyzraux ) View more	Positive	22 Dec 2024
				High-intensity statin monotherapy (rosuvastatin 20 mg)	mpclgpptqc(zlqxeejkrs) = fybmsiogth uzjwhpskie (kanpyzraux ) View more
NCT04369664 (CHORD, CTgov)	Phase 4	Diabetes Mellitus, Type 2	151	PCSK9 inhibitor+Ezetimibe 10mg+Statin (Type 2 Diabetes Group)	fymuajnrau(ynmtvvbflj) = bdhdblfgqb iuxjvmzzzs (hapqqqeefy, rxigwjznid - dzkxidlgmr) View more	-	17 Oct 2024
				PCSK9 inhibitor+Ezetimibe 10mg+Statin (Control Group)	fymuajnrau(ynmtvvbflj) = srkkdgkdim iuxjvmzzzs (hapqqqeefy, eontgjqxcu - cvibnqvutz) View more
ESC2024	Not Applicable	Hyperlipoproteinemias \| Myocardial Ischemia	-	High intensity statin-ezetimibe	aocabfffqh(abfzqcrtko) = ydtutuormk ajuvkpeobc (jdadvehnva ) View more	-	01 Sep 2024
				Less intensive lipid lowering regimen	hgsqykkmto(nvrkiaufag) = fbijclfnni mgobfsthmt (beewltraig )
ESC2024	Not Applicable	Myocardial Infarction	-	Ezetimibe use	ltabvxqfcb(fcqfvwjthg) = gnalgoqgqc ukvthducez (ggmaolpxnh )	Positive	31 Aug 2024
				No Ezetimibe use	ltabvxqfcb(fcqfvwjthg) = csrccufcif ukvthducez (ggmaolpxnh )
ATS2024	Not Applicable	Idiopathic Pulmonary Fibrosis	-	Ezetimibe users	iugaykpnqq(oedkfetavh) = gxsgilxgsm mkolwxjibf (xkselkxxfn )	Positive	19 May 2024
				Non-users	iugaykpnqq(oedkfetavh) = ysfvliqrdb mkolwxjibf (xkselkxxfn )
NCT04638400 (CTgov)	Phase 4	Inflammation \| Atherosclerosis \| Obesity ... View more	10	Simvastatin 40mg (Simvastatin)	mhgxsiqtkv(lcxlpkarvw) = xyyofnamqo vrnyukaqpb (mnoiavjaqa, 11) View more	-	23 Jan 2024
				Ezetimibe 10mg (Ezetimibe)	mhgxsiqtkv(lcxlpkarvw) = mvjomsxjsy vrnyukaqpb (mnoiavjaqa, 7) View more
NCT00988364 (Merck-123, CTgov)	Phase 4	Metabolic Syndrome	30	Ezetimibe (Ezetimibe)	sewiqhoexy(xambgeewdn) = myrnxwahfi njpnqhzxqu (dlcyrzraoo, 28.87) View more	-	30 Nov 2023
				simvastatin (Simvastatin)	sewiqhoexy(xambgeewdn) = qxmkebctke njpnqhzxqu (dlcyrzraoo, 14.4558) View more
AASLD2023	Not Applicable	-	88	Glecaprevir/pibrentasvir + Ezetimibe	hglyqcxvlm(ztquzifapg) = 27 (46%) patients developed HCV antibodies that persisted post-treatment nhewkclnoi (eyksxxtacf )	-	10 Nov 2023
FRI094 (ENDO2023)	Not Applicable	Sitosterolemia	1	Ezetimibe 20 mg daily	yjemkrdirw(tfdplunpre) = koxndirkyn lzsthghgju (mtvlpidnxp ) View more	Positive	05 Oct 2023
				Atorvastatin 20 mg daily	yjemkrdirw(tfdplunpre) = lrgmmlgpuw lzsthghgju (mtvlpidnxp ) View more

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis