Drug Database
EZ

ezetimibe + rosuvastatin (NVP1205 / NVP 1205)

✓ Approved

NVP Healthcare · HMGCR · Small Molecule

What is ezetimibe + rosuvastatin?

ezetimibe + rosuvastatin is a small molecule developed by NVP Healthcare. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesNVP1205, NVP 1205
CompanyNVP Healthcare
Drug ClassSmall Molecule
Molecular TargetHMGCR, NPC1L1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, NVP Healthcare

Mechanism of Action

Molecular Targets

ezetimibe + rosuvastatin acts on 2 molecular targets:

HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
NPC1L1NPC1 like intracellular cholesterol transporter 1 (SLC65A2, LDLCQ7)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ezetimibe + rosuvastatin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHyperlipidaemia✓ Approved

Related Research Articles

PubMedFrontiers in endocrinology2026-07-25

A multi-center, open-label, observational study to evaluate the efficacy and safety of LivaloZet® tablets in patients with dyslipidemia and metabolic syndrome: PIVOT study protocol.

Joung Kyong Hye KH, Ku Bon Jeong BJ

Dyslipidemia accompanied by metabolic syndrome substantially elevates cardiovascular risk by clustering multiple risk factors, including abdominal obesity, hypertension, hyperglycemia, and atherogenic dyslipidemia. The prevalence of both conditions is rising in Korea, underscoring the need for effective and metabolically safe lipid-lowering therapy. LivaloZet® Tablet (pitavastatin/ezetimibe fixed-dose combination) addresses this need by combining complementary cholesterol-lowering mechanisms with the glucose-neutral profile of pitavastatin. The PIVOT study is a multi-center, non-interventional, prospective observational study enrolling up to 10,000 Korean adult patients with dyslipidemia accompanied by metabolic syndrome who have been prescribed LivaloZet® Tablets (pitavastatin/ezetimibe 2/10 mg or 4/10 mg) by their treating physician as part of routine clinical care. Metabolic syndrome is defined according to the modified NCEP-ATP III criteria for the Asian population. Assessments are conducted at baseline, Week 24, and Week 48. The primary endpoint is the percent change in low-density lipoprotein cholesterol (LDL-C) from baseline at Week 24. Secondary endpoints include LDL-C changes at Week 48, changes in the full lipid panel, and LDL-C target achievement rates by cardiovascular risk group. Exploratory endpoints encompass glucose metabolism parameters (HbA1c, HOMA-IR, HOMA-β), medication adherence and persistence, and high-sensitivity C-reactive protein. Safety is assessed through adverse events, laboratory tests, and vital signs, including systematic monitoring of AST, ALT, and creatine kinase for statin-related hepatotoxicity and myopathy. The study was approved by the Institutional Review Board of Chungnam National University Hospital (2025-07-065) and is registered at ClinicalTrials.gov (NCT07523971). The PIVOT study will generate prospective large-scale real-world evidence on the LDL-C-lowering effectiveness and safety patterns associated with use of a pitavastatin/ezetimibe fixed-dose combination in Korean patients with dyslipidemia accompanied by metabolic syndrome. The inclusion of glucose metabolism and inflammatory markers will provide descriptive information on the metabolic safety profile of this regimen. As a non-randomized, single-arm observational study, this design cannot establish causal effects or comparative efficacy versus other lipid-lowering regimens. Findings should be interpreted descriptively, acknowledging potential confounding by indication, selection bias, and inter-laboratory variability.

PMID 42500128
Read full article →
PubMedF&S science2026-07-24

Rosuvastatin mitigates ovarian ischemia-reperfusion injury in rats by modulating oxidative stress, inflammation, and angiogenesis.

Vahedi Nima N, Jafary Saleh S, Beheshti Rahim R

To investigate the protective effects of rosuvastatin against ovarian ischemia-reperfusion injury (I/R) in a rat model. Controlled experimental study using an induced ovarian torsion-detorsion model. Fifty adults female Wistar rats (aged 8-10 weeks, weighing 100-150 g). Intraperitoneal administration of rosuvastatin (5 mg/kg) 30 minutes before induction of ischemia in the designated treatment groups. Ovarian tissue levels of myeloperoxidase (MPO), malondialdehyde (MDA), total antioxidant capacity (TAC), and activities of superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT); mRNA expression of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), tumor necrosis factor-α (TNF-α), and caspase-3; and semi-quantitative histopathological scoring of tissue damage. Ischemia and I/R significantly elevated MPO, MDA, VEGF, bFGF, TNF-α, and caspase-3 levels while worsening histological damage. Rosuvastatin pretreatment reduced MPO by 13%-16%, MDA by 9%, VEGF by 7%-14%, bFGF by 14%-37%, TNF-α by 34%-38%, and caspase-3 by 31%-39%; increased TAC by 20%; and markedly improved histopathological scores, including reduced follicular atresia. No significant changes were observed in SOD, GPx, or CAT activities. Rosuvastatin exerts protective effects against ovarian I/R by attenuating oxidative stress, inflammation, excessive angiogenesis, and apoptosis, independent of major antioxidant enzyme induction. These preclinical findings suggest potential adjunctive utility in limiting reperfusion injury after detorsion; however, protein-level validation, dose-response studies, post-ischemic administration, long-term fertility outcomes, and safety assessments are required before any clinical translation.

PMID 42492670
Read full article →
PubMedRSC advances2026-07-24

pH-responsive chitosan based hydrogels for the simultaneous delivery of atorvastatin calcium and ezetimibe.

Shabbir Naba N, Siddique Waqar W, Riaz Humayun H, Zaman Muhammad M et al.

The management of cholesterol by using Atorvastatin calcium (ATV) and Ezetimibe (EZE) is often restricted by the fact that they belong to BCS Class II drugs, thus, low aqueous solubility and low systemic bioavailability. The research has created a new pH-responsive hydrogel involving a natural polycationic polysaccharide, chitosan, to increase residence time in the sites of absorption and offer controlled, concurrent delivery of both drugs. The hydrogels were synthesized through a free-radical polymerization process, which entailed dissolving chitosan in aqueous acetic acid, initiation by ammonium persulfate (APS) and addition of acrylic acid (AA) and N,N'-methylene bisacrylamide (MBA) in drops to create a stable 3D cross-linked structure. The numerical optimization was performed with Design Expert software, in which the ratios of components are accurately tuned with the help of the use of the poly equations and 3D response surface plots. This methodology removed hit and trial error leading to a maximized formulation in which the real experimental values, including 87.98% porosity and 98.76% gel fraction, were in good agreement with the software predictions, which confirmed the strength of the design. Findings showed that the internal structure was greatly determined by the formulation parameters; the higher the monomer concentrations, the better the porosity (97.53%) and the gel fraction (97.79%). The system was also very pH-sensitive as it swelled little in acidic environment (pH 1.2) but swelled the most (187.71%) in simulated intestinal fluids (pH 6.8 and 7.2) which allowed the system to dissolve 91.99% of ATV and 90.77% of EZE within 24 h. This mathematically designed platform with dual drug delivery is designed to overcome the drawbacks of a single-drug matrix for cholesterol management and prevent premature leakage from the stomach.

PMID 42495560
Read full article →
PubMedDrug metabolism and bioanalysis2026-07-23

Bioanalytical Method for Simultaneous Quantification of Itraconazole and Atorvastatin in Human Plasma.

Bodiwala Kunjan B KB, Pujara Flora J FJ, Khadela Avinash D AD, Savale Shrinivas S SS

Drug-drug interactions between statins and azole antifungal agents, due to the inhibition of the CYP3A4 enzyme by antifungals, increase the risk of adverse effects from statins. Thus, a precise bioanalytical method for quantifying Itraconazole and Atorvastatin in human plasma is essential. A liquid chromatographic method with protein precipitation and liquidliquid extraction was developed. Rosuvastatin calcium served as the internal standard. The method was validated per ICH M10 and USFDA guidelines and used to analyze spiked plasma samples. The method effectively separated Itraconazole, Atorvastatin, and the internal standard without plasma interference. It achieved linear responses for each drug in the 0.1-3.0 μg/mL range with regression coefficients > 0.99. The RSD for within-run and between-run responses was < 5%, and the average recovery exceeded 64%. The method accurately and precisely measured each analyte at the LLOQ level (0.1 μg/mL). A sensitive and selective bioanalytical HPLC method was developed, validated, and applied for the simultaneous estimation of Itraconazole and Atorvastatin in human plasma. This method ensures safe and effective co-administration of these medications in clinical practice, benefiting patient care.

PMID 42489331
Read full article →
PubMedCardiovascular drugs and therapy2026-07-23

Guideline-directed Low-density Lipoprotein Cholesterol Management After Acute Coronary Syndrome in Patients With Mental Illness: a Population-based Study.

Avidan Yuval Y, Kobo Ofer O, Weizman Baruch B, Jonas Matan M et al.

Despite increased cardiovascular morbidity among patients with mental disorders, real-world data on lipid-lowering therapy (LLT) use and low-density lipoprotein cholesterol (LDL-C) target attainment after acute coronary syndrome (ACS) remain limited. We evaluated disparities in LLT utilization and LDL-C target attainment among patients with and without mental disorders following ACS in a real-world setting. Data of consecutive ACS hospitalizations in a large healthcare system (2013-2023) were analyzed. Patients were stratified by mental illness and compared with controls. LDL-C target attainment and LLT use were assessed at baseline and during early (1-4 months) and late (6-12 months) post-discharge periods. Multivariable logistic regression evaluated independent associations. Among 9,192 patients surviving ≥ 1 year after ACS, 32.1% had mental illness. These patients were older, more often female, and had higher atherosclerotic burden (p < 0.001). LDL-C target attainment was lower in patients with mental illness both early (49% vs. 54%) and late (44% vs. 49%) after discharge, with fewer achieving ≥ 50% LDL-C reduction (p < 0.001). High-intensity statin and early ezetimibe use were less frequent (p = 0.005), and non-adherence was higher (9.7% vs. 6.3%, p = 0.001). In adjusted analyses, mental illness was not independently associated with LDL-C target attainment but was linked to lower use of moderate- and high-intensity statins (OR 0.87 and 0.83) and higher likelihood of no LLT use (OR 1.48; p < 0.01). Mental disorders were associated with lower LLT intensity and greater treatment gaps after ACS, without independent differences in LDL-C attainment. LDL-C control and combination LLT use remained suboptimal, highlighting persistent gaps in secondary prevention.

PMID 42490040
Read full article →
PubMedFrontiers in pharmacology2026-07-23

Pharmacovigilance assessment of gout: a real-world study using the FAERS database.

Ren Honghao H, Yao Nannan N, Ren Xiaodong X, Su Yani Y et al.

Drug intervention is a key method for preventing gout, various drugs have been implicated as potential risk factors in individual studies. This study aims to comprehensively identify drugs linked to the development of gout. Data were obtained from the FDA Adverse Event Reporting System (FAERS), and disproportionality analysis was employed to quantitatively assess the associations between drugs and gout. Four complementary signal detection methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were utilized. To further delineate exposure-outcome relationships and identify influential predictors, least absolute shrinkage and selection operator (LASSO) logistic regression was implemented. Time-to-onset (TTO) analysis was conducted to examine the temporal dynamics between drug initiation and the occurrence of gout. Finally, a comprehensive assessment of the therapeutic indications of the drugs was performed. A total of 35 drugs were ultimately identified as potentially associated with the onset and progression of gout. Among these, several agents have been previously reported in the literature as having possible links to gout development. In addition, a number of novel candidates were detected for which evidence of an association with gout remains limited or has not been clearly established. These include Lenalidomide, Sacubitril valsartan, Ruxolitinib, Treprostinil, Octreotide, Selexipag, Rosuvastatin, Sitagliptin, Riociguat, Epoprostenol, Patiromer, Dasabuvir ombitasvir paritaprevir ritonavir, Tafamidis, Sparsentan, and Iloprost. Furthermore, TTO analysis suggested that approximately 75% of gout events occurred within 0.6 years following initiation of therapy. These pharmacotherapeutic agents are employed across diverse clinical settings, encompassing haematological malignancies, cardiovascular diseases, and pulmonary hypertension. These findings suggest the potential for targeted monitoring of drug-associated gout in clinical practice. When administering these medications, it may be crucial to regularly assess patients' uric acid levels and maintain heightened awareness for the possible onset of gout.

PMID 42488563
Read full article →

+9402 more articles available with a free account

Sign up free to view all articles →

Ask about ezetimibe + rosuvastatin