An Open-Label, Multiple-oral Dosing, Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic Drug-Drug Interaction Between HUC2A-752-A and HUC2A-752-B in Healthy Adults

This study evaluates the pharmacokinetic drug-drug interactions of repeated co-administration of HUC2A-752-A and HUC2A-752-B compared to monotherapy of each agent in healthy adults

Start Date01 Oct 2026

Sponsor / Collaborator

Huons Co., Ltd.

TCTR20260920003

/ Not yet recruitingPhase 4

Efficacy of Generic vs. Original Rosuvastatin 20 mg and Ezetimibe 10 mg Free-Combination Therapy on LDL-C Reduction: A Non-inferiority Trial

Start Date30 Sep 2026

Sponsor / Collaborator

Berlin Pharmaceutical Industry Co. Ltd.

100 Clinical Results associated with Ezetimibe

100 Translational Medicine associated with Ezetimibe

100 Patents (Medical) associated with Ezetimibe

3,564

Literatures (Medical) associated with Ezetimibe

01 Jan 2027·TALANTA

Simultaneous separation of ezetimibe and its seven stereoisomers by supercritical fluid chromatography on a polysaccharide-based chiral stationary phase: Optimization and thermodynamic analysis

Article

Author: Liu, Hao ; Zhu, Liping ; Zheng, Luxia ; Chen, Yang ; Le, Jian ; Jin, Wei ; Li, Wanjie

The separation behavior of ezetimibe and its seven stereoisomers was investigated using supercritical fluid chromatography (SFC). Polysaccharide-based chiral stationary phases (CSPs) were employed to systematically evaluate the effects of column type, modifier composition and ratio, column temperature and back pressure on the resolution. Optimal separation was achieved on the Chiralpak AD-H column using a mixture of methanol and isopropanol (1:1, v/v) as the organic modifier. The flow rate, column temperature and back pressure were set at 2 mL/min, 40 °C and 2200psi, respectively. The impact of column temperature varied across different enantiomeric pairs, with a notable reversal of elution order observed for the SRR/RSS pair. Method validation demonstrated excellent linearity for ezetimibe and its seven stereoisomers within their individual calibration ranges, which collectively covered 1.46-111.89 μg/mL, with correlation coefficients above 0.999. The limits of detection and quantification for individual analytes ranged from 0.6 to 3.5 μg/mL and from 1.3 to 10.6 μg/mL, respectively. The developed method was successfully applied to the determination of ezetimibe stereoisomers in both bulk drug and tablet samples, confirming its applicability for routine quality control. These results indicate that the developed SFC method is efficient, reliable and suitable for the quantitative determination of ezetimibe and its stereoisomers.

01 Jan 2027·ARCHIVES OF MEDICAL RESEARCH

Mexican Registry of Dyslipidemias of the Mexican Institute of Social Security: Lipid Profiles in Patients at High and Very High Cardiovascular Risk

Article

Author: Hernández, Víctor Alonso Hernández ; Rendón, Sadoc Marín ; Rendón, América Fabiola Benítez ; López, Marcos Eliffaletth Ortega ; Aceves, Iván Cruz ; Hernández, Sergio Eduardo Solorio ; Jiménez, Yoloxóchitl García ; Gutiérrez, Jorge Luis Ochoa ; López, Nydia Rocío Romero ; Moreno, Pedro Atdonis Carrillo ; Rincón, Luis Ernesto Balcázar ; Bravo, Mariana Hernández ; Sámano, Alma Leticia Flores ; Zepeda, Francisco Solorzano ; Magallanes, María Teresa Muñoz ; Meza, Sergio Eduardo Solorio ; Hernández, Miriam Pérez ; Cardiel, Alfonso Sánchez ; Aladro, Alicia Ceja ; Mendoza, Luis Fernando Razo ; Alvarado, Francisco Javier García ; Aranda, Margie Icxiuh Melgar ; Álvarez, Vanessa Domínguez ; Méndez, Rosalba Carolina García ; Vázquez, Blanca ; Vázquez, Yureni Uribe ; Rivas, Jesús Elizarrarás ; Mazón, Marco Antonio León ; Reyes, Irma Angélica Aroche ; Pérez, Geovani Sabino Alvarado ; Escobar, Yarenis Santiago ; Aréchiga, Zaria Margarita Benítez ; Hernández, María Magdalena Valle ; Jiménez, Laura Ávila ; Ramos, Xóchitl Ramos ; López, María Honorina Patricia Martínez ; Aguirre, Arturo Hernández ; Maldonado, Jesús Alejandro Delgado ; González, Juan Ignacio Soto ; Pon, Raquel Alfaro ; García, Jesús Alejandro Gómez ; Hernández, Juan Pablo Fernández ; Granados, Oqui Quetzalli Félix ; Arriaga, Christian Iván Enríquez ; Sabido, Rafael Rascón ; González, Daniel Alejandro Gómez ; Rincón, María de Jesús Ayala ; Michel, Rodolfo Parra ; Martínez, Braulio Sinhué Rodríguez ; León, Héctor Armando Rincón ; Sánchez, Marisela Jiménez ; García, Patricia Berenice Bolado ; Astorga, José Gilberto Heredia ; Velázquez, Cristina Flores ; Balderas, Eileen Amaro ; Pérez, Virginia Lagunas ; Velasco, Frida Salazar ; Martínez, Mirna Melissa Gordillo ; Mier, Gustavo Martínez ; Tirado, Josué Páez ; Durán, José Ángel Martínez ; Bañuelos, Elena Verdugo ; Aguirre, Luis Alberto Arboine ; Enríquez, José Luis Cantú ; Domínguez, María del Pilar Cruz ; Sierra, Luis Adriel Yáñez ; Santiago, Moisés Iván Vásquez ; López, Jacqueline Calderón ; García, Eva del Carmen Palacios ; Medina, Lauro Fabián Amador ; Sanabria, Laura Cortés ; Palacios, Carlos David Jiménez ; Alfonzo, Laura Cecilia Bonifaz ; Gutiérrez, Eduardo Almeida ; Hevia-Montiel, Nidiyare ; Batalla, Juana Marlen Ruiz ; Santiesteban, Paul Constantino ; Rosales, María del Pilar Carranza ; Torres, Valery Fabiola Lerma ; Arce, Cindy Sharon Ortiz ; Sánchez, Gabriela Borrayo ; Martínez, Pedro Mendoza ; Salgado, Ricardo Castrejón ; Gámez, Juan Carlos Pérez ; Infante, Eric Andrés Martínez ; López, Fany Karina Segura ; Lara, Magdalena Soto ; Gómez, María José Fernández ; Hernández, Erick Alejandro Solorio ; Galván, Marai Xochitl Gutiérrez ; Delgado, Nancy Elena Guzmán ; Hernández, Melisa Alejandra Muñoz ; González, Martha Alicia Hernández ; Ramírez, Silvia Amparo Ledesma ; Tapia, Edward Ochoa ; Valentón, Elizabeth Medina

BACKGROUND:

Cardiovascular disease remains the leading cause of morbidity and mortality in Mexico. Dyslipidemia is a major modifiable cardiovascular risk factor; however, national data describing lipid profiles and achievement of low-density lipoprotein cholesterol (LDL-C) targets among patients at high and very high cardiovascular risk across all levels of health care are limited.

OBJECTIVE:

To characterize lipid profiles, associated comorbidities, and LDL-C target attainment among Mexican patients at cardiovascular risk enrolled in the Mexican Registry of Dyslipidemias (REMEXDIS-IMSS).

METHODS:

A cross-sectional analysis of baseline data from the ongoing REMEXDIS-IMSS multicenter prospective observational cohort is reported. Between September 2022 and January 2024, adults at high or very high cardiovascular risk were recruited from participating Mexican Institute of Social Security (IMSS) centers. Baseline demographic, clinical, and biochemical data were collected through standardized outpatient assessments and are presented as medians (interquartile range) or frequencies and percentages. Comparisons were performed using the Mann-Whitney U test and χ² test.

RESULTS:

Overall, 51.3% of participants were classified as being at high cardiovascular risk and 48.7% at very high cardiovascular risk. The median age was 64 years, and 54.3% of participants were women. Diabetes mellitus, hypertension, and smoking were present in 64.7, 67.4, and 33.2% of participants, respectively. LDL-C targets were achieved by 56.4% of patients at high cardiovascular risk and 43.1% of those at very high cardiovascular risk. Greater treatment intensity was consistently associated with improved LDL-C control, with the highest rate of target attainment observed among patients receiving triple lipid-lowering therapy (a statin, ezetimibe, and a PCSK9 inhibitor).

CONCLUSIONS:

In this large national cohort, nearly 50% of the patients at high and very high cardiovascular risk, particularly those at very high risk, did not achieve the recommended LDL-C targets, highlighting the need to intensify lipid-lowering therapy and improve access to combination treatment in routine clinical practice.

01 Dec 2026·Blood Research

Sitosterolemia presenting as unexplained cytopenias: hematologic manifestations and genetic spectrum

Letter

Author: Mishra, Navneet ; Bansal, Naman ; Gupta, Nitin ; Verma, Meena ; Kotwal, Jyoti

BACKGROUND:

Sitosterolemia is a rare autosomal recessive disorder caused by pathogenic variants in the ATP-binding cassette subfamily G member 5 (ABCG5) or ATP-binding cassette subfamily G member 8 (ABCG8) gene, which increase the intestinal absorption of plant sterols and reduce their biliary excretion. It is classically linked to xanthomas and premature cardiovascular disease; however, many patients first present with haematologic abnormalities, often leading to diagnostic delay.

METHODS:

We retrospectively reviewed six consecutive patients with clinical features suggestive of sitosterolemia and molecular variants in the ABCG5 or ABCG8 gene who were treated at a tertiary referral center between January 2024 and June 2026. We analyzed their clinical features, hematologic findings, genetic variants, treatment, and follow-up outcomes.

RESULTS:

Six patients (three men and three women; median age, 40 years [range, 22-55 years]) presented with anemia, thrombocytopenia, and splenomegaly but were initially misdiagnosed with more common disorders, such as immune thrombocytopenia, iron-deficiency anemia, megaloblastic anemia, and Evans syndrome. All patients had stomatocytes and giant platelets on peripheral blood smears; three also had tendon xanthomas, and one had premature coronary artery disease. Genetic testing predominantly identified ABCG8 variants, as well as two ABCG5 variants, including a homozygous ABCG5 c.1724 T > G (p.Leu575Arg) variant that has not been previously reported and is currently classified as a variant of uncertain significance. All patients were advised to follow a phytosterol-restricted diet, and five received ezetimibe. Four patients with available follow-up data showed improvements in hemoglobin, platelet count, and spleen size during 4-12 months of follow-up. One patient was lost to follow-up, and one patient had insufficient follow-up for outcome assessment.

CONCLUSION:

Sitosterolemia should therefore be considered in patients with unexplained cytopenias, stomatocytosis, macrothrombocytopenia, and splenomegaly. Early recognition and genetic confirmation of this condition allows timely treatment with dietary modification and ezetimibe, thereby improving hematologic outcomes and preventing unnecessary investigations.

316

News (Medical) associated with Ezetimibe

05 Oct 2026

·www.biospace.com

NewAmsterdam Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 2, 2026

NAARDEN, The Netherlands and MIAMI, Oct. 02, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the Compensation Committee of NewAmsterdam’s Board of Directors approved the grant of inducement share options covering an aggregate of 71,800 of NewAmsterdam’s ordinary shares to 7 non-executive new hires. The share options were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the NewAmsterdam Pharma Company N.V. 2024 Inducement Plan (the “2024 Inducement Plan”) and in accordance with Nasdaq Listing Rule 5635(c)(4). The share options have an exercise price per share equal to $24.16, which represents the closing market price on the Nasdaq Stock Market of the Company’s ordinary shares on October 1, 2026, the grant date. The shares subject to the options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 equal monthly installments thereafter, subject to each employee’s continued service with NewAmsterdam on such vesting dates. The options are subject to the terms and conditions of the 2024 Inducement Plan and the terms and conditions of an option award agreement covering the grant. The Compensation Committee of NewAmsterdam’s Board of Directors also approved the grant of restricted stock units covering an aggregate of 17,745 of NewAmsterdam’s ordinary shares to 7 non-executive new hires. The restricted stock units were granted as an inducement material to the employees’ acceptance of employment with NewAmsterdam pursuant to the 2024 Inducement Plan and in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units were granted on October 1, 2026. The restricted stock units will vest over three years, with one-third of the restricted stock units vesting on each of the one-year, two-year and three-year anniversaries of the applicable vesting commencement date, subject to each employee’s continued service with NewAmsterdam on such vesting dates. The restricted stock units are subject to the terms and conditions of the 2024 Inducement Plan and the terms and conditions of a restricted stock unit award agreement covering the grant. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to building a new standard of care for people living with cardiometabolic and neurodegenerative diseases. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose. Company Contact Matthew Philippe P: 1-917-882-7512 matthew.philippe@newamsterdampharma.com

Phase 3AHA

29 Sep 2026

·www.biospace.com

NewAmsterdam Pharma Doses First Participant in Phase 2b SPINOZA Trial Evaluating Obicetrapib in Preclinical Alzheimer’s Disease

- SPINOZA is studying obicetrapib in adults with biomarker evidence suggestive of preclinical Alzheimer’s disease who do not have noticeable memory or functional symptoms- - The study will evaluate changes in blood-based biomarkers associated with Alzheimer’s disease, including p-tau 217, and additional cognitive and functional measures- NAARDEN, the Netherlands and MIAMI, Sept. 29, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first participant in SPINOZA, a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer’s disease. "The first participant dosed in SPINOZA marks an important milestone for NewAmsterdam as we expand the clinical evaluation of obicetrapib in Alzheimer's disease," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. "Alzheimer's disease pathology typically begins years before clinical symptom onset, creating an opportunity for intervention. The commencement of this trial is an important step in our effort to understand whether obicetrapib may affect biological changes associated with the disease before noticeable symptoms develop. The findings from our BROADWAY Alzheimer’s disease biomarker analysis, together with the growing body of evidence linking lipid metabolism to Alzheimer's disease pathology, provide a strong scientific rationale for further evaluating the effect of obicetrapib on biomarkers associated with disease progression and neurodegeneration." SPINOZA is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of obicetrapib in approximately 400 participants with preclinical Alzheimer's disease. Eligible participants have biomarker evidence consistent with early Alzheimer's disease pathology and carry ApoE4/E4, ApoE3/E4 or ApoE3/E3 genotypes. Participants will be randomized 1:1, stratified by genotype, to receive obicetrapib 10 mg or placebo for 52 weeks. Following completion of the double-blind treatment period, participants may enter a 26-week open-label extension study during which all participants will receive obicetrapib. The SPINOZA trial design was informed by findings from the prespecified Alzheimer’s disease biomarker analysis in the Company’s Phase 3 BROADWAY trial, which demonstrated the strongest observed biomarker response in ApoE4/E4 participants and supportive signals across additional genotype-defined populations. These findings informed the genotype-stratified design of SPINOZA and the selection of enrollment criteria intended to further evaluate the effects of obicetrapib on biomarkers associated with Alzheimer's disease pathology and neurodegeneration. SPINOZA further expands NewAmsterdam's clinical development program for obicetrapib alongside its ongoing Phase 3 REMBRANDT, RUBENS and PREVAIL clinical trials. People interested in learning more about the SPINOZA trial can visit spinoza.longboat.com . Additional eligibility criteria apply, and eligibility can only be determined by the study team following the required screening assessments. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect pro to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About the Phase 2b SPINOZA Trial The SPINOZA trial is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study evaluating the effect of obicetrapib on plasma p-tau217 and other biomarkers associated with Alzheimer’s disease pathology and neurodegeneration in approximately 400 participants with preclinical Alzheimer's disease. Eligible participants are adults aged 55 to 85 years with preclinical Alzheimer's disease (Stage 1 or Stage 2) as defined by FDA guidance for Early Alzheimer's Disease drug development, a Mini-Mental State Examination (MMSE) score of at least 27, a global Clinical Dementia Rating (CDR) score of 0.5 or lower, and biomarker evidence of Alzheimer's disease pathology. Enrollment is restricted to participants with ApoE4/E4, ApoE3/E4, or ApoE3/E3 genotypes. Participants will be randomized 1:1 to receive obicetrapib 10 mg or placebo, stratified by genotype. The primary efficacy endpoint is change from baseline to Week 52 in plasma phosphorylated tau 217 (p-tau217), a biomarker associated with Alzheimer’s disease pathology. Secondary endpoints include changes in plasma Alzheimer's disease biomarkers, including Aβ42/Aβ40, p-tau217/Aβ42, p-tau217/Aβ42/40 and BD-tau, as well as change from baseline to Week 52 in the Preclinical Alzheimer's Cognitive Composite 5 (PACC5) score. Following completion of the 52-week double-blind treatment period, eligible participants may choose to enter an open-label extension lasting at least 26 weeks, during which all participants will receive obicetrapib. BROADWAY Alzheimer’s Analysis In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aβ42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.025; n= 1,535) and in ApoE4 carriers (p=0.022; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to building a new standard of care for people living with cardiometabolic and neurodegenerative diseases. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: the therapeutic potential of the Company’s product candidate; the design, progression, timing and objectives of the Company’s clinical trials, including the SPINOZA trial; and other statements regarding the Company's future operations, prospects, objectives, strategies and other future events. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: uncertainties inherent in research and development, in the initiation and advancement of clinical trials and in the clinical development of obicetrapib in preclinical Alzheimer’s disease; whether results of early clinical trials and analyses will be indicative of the results of later clinical trials and analyses; risks to clinical trial site initiation, patient enrollment and follow-up; changes in domestic and foreign business, market, financial, political, and legal conditions; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, as well as in other filings the Company may make with the SEC in the future, which are available at Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law. Company Contact Matthew Philippe P: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media Contact Real Chemistry on behalf of NewAmsterdam Christian Edgington P: 1-513-310-6410 cedgington@realchemistry.com Investor Contact Precision AQ on behalf of NewAmsterdam Austin Murtagh P: 1-212-698-8696 austin.murtagh@precisionaq.com

Phase 2Phase 3Clinical Result

22 Sep 2026

·www.pharmaceutical-technology.com

EC approves Menarini and NewAmsterdam’s obicetrapib therapies

Obicetrapib is being developed as a low-dose, oral CETP inhibitor for lowering LDL cholesterol in patients unresponsive to treatments. Credit: PeopleImages / Shutterstock.com. The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination). The authorisation allows both treatments to be used for patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial forms or mixed dyslipidaemia. This is said to be the first regulatory approval anywhere in the world for obicetrapib. The EC’s decision follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use. Backing for the approval comes from data in NewAmsterdam’s clinical development programme, including Phase III BROADWAY, BROOKLYN and TANDEM trials. Results from these studies showed statistically significant reductions in Low-density lipoprotein (LDL) cholesterol, with obicetrapib monotherapy reducing LDL-C by up to 40% compared to placebo, and the combination with ezetimibe reducing it by about 50%. The safety profile was reported as similar to placebo. Under the collaboration, Menarini holds exclusive rights to market obicetrapib in Europe and is responsible for regulatory and commercial activities there. NewAmsterdam will receive tiered double-digit royalties and could qualify for up to €833m in milestone-related payments. Both firms continue to evaluate obicetrapib in ongoing Phase III trials, including PREVAIL, REMBRANDT, and RUBENS. Obicetrapib is being developed as a low-dose, oral Cholesteryl ester transfer protein (CETP) inhibitor for lowering LDL cholesterol in patients who do not respond adequately to existing treatments. NewAmsterdam Pharma CEO Michael Davidson said: “The EC approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies. “This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine. “Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world.” In March 2025, the Menarini Group and its subsidiary Stemline Therapeutics announced a partnership with VisualDx to enhance the detection of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Phase 3Drug ApprovalClinical Result

100 Deals associated with Ezetimibe

External Link

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.

to view more data

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. USA	12 Jul 2005
Angina, Unstable	Phase 3	-	Organon & Co.	12 Jul 2005
Angina, Unstable	Phase 3	-	Schering-Plough Corp. USA	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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2026	Not Applicable	ST Elevation Myocardial Infarction	78	Statin	hfzrsicgnk(haeffuxhhs) = gpppadouvr lryihuyefk (nsvlpxheog ) View more	Positive	29 Aug 2026
ESC2026	Not Applicable	Acute Coronary Syndrome	426	Rosuvastatin-Ezetimibe-Bempedoic Acid	gmjhekhzll(ppiolpmali) = mwtkkqqwjh zbywdzngdm (mckplduojt )	Negative	28 Aug 2026
NCT04826354 (SaveSAMS, Pubmed \| J Am Heart Assoc)	Phase 4	Atherosclerosis	318	High-intensity statin monotherapy (rosuvastatin 20 mg)	ajjgqitgwc(ifewimmfyo) = pijdzyqmpz llprpgbzuu (xzbjwikzzx ) View more	Positive	07 Jul 2026
NCT04826354 (SaveSAMS, Pubmed \| J Am Heart Assoc)	Phase 4	Atherosclerosis	318	Moderate-intensity statin plus ezetimibe (rosuvastatin 5 mg/ezetimibe 10 mg)	ajjgqitgwc(ifewimmfyo) = vbdslhjxbm llprpgbzuu (xzbjwikzzx ) View more	Positive	07 Jul 2026
NCT06450366 (MK-0616-018, CTgov)	Phase 3	Hypercholesterolemia	301	Placebo for Ezetimibe+Enlicitide (Enlicitide)	moksenwcwf(dslznxekaw) = eimutuzbrs lntckncpxq (hfpvgglzid, nwpmaoobbu - yhpwpebupy) View more	-	27 Mar 2026
NCT06450366 (MK-0616-018, CTgov)	Phase 3	Hypercholesterolemia	301	Placebo for Ezetimibe+Bempedoic Acid (Bempedoic Acid)	moksenwcwf(dslznxekaw) = kbpaewganp lntckncpxq (hfpvgglzid, gmbugqqitr - ginwkcgfea) View more	-	27 Mar 2026
ESC2026	Not Applicable	Acute Coronary Syndrome	102	Rosuvastatin 40 mg + Ezetimibe 10 mg	isqbgqnbdx(jiqaizstkn) = dornaadizp ffoibiawae (wbjxgphpdn ) View more	Positive	20 Mar 2026
AASLD2025	Not Applicable	Hepatitis C	113	Glecaprevir/Pibrentasvir + Ezetimibe	nlzlwwvabc(qidjioqxre) = ggwiguwpjc rlcygkieeo (jyggstzpqc ) View more	Positive	07 Nov 2025
ESC2025	Not Applicable	Lipid Metabolism Disorders	86	intensive lipid-lowering treatment protocol	wlmarqtirk(rrkilerfkk) = Only one patient discontinued statins due to myalgias, with no other significant adverse effects reported gwptawvwoz (ktnhearrkl )	Positive	01 Sep 2025
MILOS (ESC2025)	Not Applicable	Complex dyslipidemia \| Hypercholesterolemia	2,121	Bempedoic acid	klpzvkxpdo(ajcusrtrbv) = tjastclvgi nxpbtcicbp (hadngqpiiv )	Positive	30 Aug 2025
MILOS (ESC2025)	Not Applicable	Complex dyslipidemia \| Hypercholesterolemia	2,121	Bempedoic acid + ezetimibe fixed-dose combination	klpzvkxpdo(ajcusrtrbv) = olioilxdlj nxpbtcicbp (hadngqpiiv )	Positive	30 Aug 2025
ESC2025	Not Applicable	Dyslipidemias \| Hypertension	1,955	Losartan+amlodipine+rosuvastatin+ezetimibe	emhnnfpggl(tttzjovpzu) = nqfmntihdc pmbgojgxyf (phfkoqcaew ) View more	Positive	30 Aug 2025
ESC2025	Not Applicable	Calcification of coronary artery	1,001	Ezetimibe + Ezetimibe	xjwxcalrxn(jcvcurehgp) = gzrtrfkfur kihrltuwds (siepvhkzhf, 0.40 - 1.57) View more	Positive	29 Aug 2025
ESC2025	Not Applicable	Calcification of coronary artery	1,001	Statin + PCSK9 inhibitors	xjwxcalrxn(qsavbnquqp) = zxdrjnonwh vpylfbtowu (rqqlesfcoc, 1.34 - 2.94)	Positive	29 Aug 2025

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