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atorvastatin strontium (Newvast)

✓ Approved

Hanmi Pharmaceutical · HMGCR · 小分子

什么是 atorvastatin strontium？

atorvastatin strontium 是一种小分子，由Hanmi Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Newvast
公司Hanmi Pharmaceutical
药物类别小分子
分子靶点HMGCR
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Hanmi Pharmaceutical

作用机制

分子靶点

atorvastatin strontium 作用于 1 个分子靶点：

HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

atorvastatin strontium 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Metabolism and nutrition disordersHypercholesterolaemia✓ Approved
Metabolism and nutrition disordersHyperlipidaemia✓ Approved

相关研究文献

PubMedAAPS PharmSciTech2026-09-10

Direct Powder Extrusion of Atorvastatin 3D-Printed Tablets for Immediate-Release: Solid-State Characterization and Dissolution Performance.

Anekalla Thirupathi Reddy TR, Bashetty Sujith Raj SR, Nalajala Navya N, Narala Nagarjuna N et al.

Thermal extrusion is a well-established approach for producing amorphous solid dispersions (ASDs) to enhance the solubility, dissolution, and bioavailability of poorly water-soluble drugs. Atorvastatin calcium trihydrate (ACT), a BCS class II lipid-lowering agent, exhibits low aqueous solubility, limited oral bioavailability, and variable absorption. The present study investigated the feasibility of fabricating immediate-release ACT tablets using a direct powder extrusion (DPE) three-dimensional (3D) printing technique, thereby enabling in situ drug amorphization and tablet fabrication in a single step. Critical process parameters (CPPs), including nozzle speed, printhead temperature, infill density, and extrusion pressure, were systematically optimized to achieve reproducible oval-shaped tablets with acceptable mechanical integrity and structural fidelity. Among the evaluated polymeric systems for improved dissolution, a combination of 25% (w/w) polyethylene glycol (PEG), 25% (w/w) polyethylene oxide (PEO), 15% (w/w) Pluronic F127, and 15% (w/w) sorbitol yielded consistent DPE printing at a 25% infill density, which has been shown to improve dissolution. The 3D-printed tablets, characterized by physicochemical, structural, and thermal analyses, confirmed successful drug amorphization. In vitro dissolution testing in phosphate buffer (PBS, pH 6.8) demonstrated rapid tablet disintegration and immediate drug release, with ~86% of ACT released within 30 min, meeting United States Pharmacopeia (USP) specifications for immediate-release ACT tablets. Accelerated stability studies (40°C/75% RH) for 3 months showed retention of the amorphous state, as confirmed from DSC and pXRD, with dissolution profiles comparable to initial results. Overall, the findings demonstrated that DPE-based thermal extrusion 3D printing enables single-step fabrication of amorphous ACT tablets with improved dissolution performance and stability, highlighting its potential as a single-step, flexible, patient-centric manufacturing platform at the point of service.

PMID 42717140
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PubMedFrontiers in medicine2026-09-10

Case Report: Balancing immunosuppression and infection-intravenous immunoglobulin in anti-HMGCR immune-mediated necrotizing myopathy complicated by severe pneumonia.

Fu Jing J, Zhao Qiong Q, Lou Jing-Bo JB, Tang Gui-Hua GH et al.

A 65-year-old male with a 3-year history of atorvastatin use presented with progressive proximal muscle weakness, dysphagia, and markedly elevated creatine kinase (2,277 U/L). Initially misdiagnosed with polymyositis, he deteriorated with severe pneumonia, septicemia, and type I respiratory failure requiring mechanical ventilation. Interleukin-6 rose from 12.83 to 610.9 pg/mL during sepsis. After confirmation of anti-HMGCR antibody positivity (18 arbitrary units [AU], cutoff >10 AU) via line blot assay, we discontinued methotrexate, maintained methylprednisolone at 40 mg, and initiated intravenous immunoglobulin (IVIG) 0.4 g/kg/day for 5 days with broad-spectrum antibiotics. Within two weeks, proximal muscle strength (MRC scale) improved from 2/5 to 4/5, IL-6 normalized to 8.56 pg/mL, and respiratory failure resolved. This case suggests that IVIG may serve as a safe immunomodulatory bridge in critically ill IMNM patients with severe infections.

PMID 42718719
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PubMedJACC. Case reports2026-09-10

Early Coronary Atherosclerosis in Homozygous Familial Hypercholesterolemia: The Importance of Aggressive Lipid Lowering.

Zachariah Don D, Thomas Anjana A, Nkheli Lindinkululeko L, Mansfield Brett B et al.

Homozygous familial hypercholesterolemia (HoFH) causes severe lifelong low-density lipoprotein-cholesterol (LDL-C) elevation and accelerated atherosclerosis from childhood. A 10-year-old boy presented with extensive tuberous xanthomas and was diagnosed with HoFH due to bi-allelic pathogenic variants in the low-density lipoprotein receptor gene. Baseline LDL-C was 663 mg/dL (17.14 mmol/L). Treatment with atorvastatin, followed by rosuvastatin and ezetimibe, reduced LDL-C to 235 mg/dL (6.08 mmol/L) with marked regression of xanthomas. One year later, he developed exertional chest pain. Coronary angiography and intravascular ultrasound demonstrated early coronary atherosclerosis with a nonobstructive 28% stenosis of the right coronary artery. This case provides an opportunity to discuss the role and limitations of currently available lipid-lowering therapies in HoFH. We review current lipid-lowering therapies and the challenges of achieving LDL-C targets in patients with HoFH, particularly in resource-limited settings. Early recognition and aggressive LDL-C lowering are essential in HoFH to prevent atherosclerosis.

PMID 42720648
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PubMedIranian journal of pharmaceutical research : IJPR2026-09-09

Synthesis and Evaluation of the Effects of Nanoparticles of Atorvastatin and Atorvastatin on Cuprizone-Induced Demyelination: Modulation of the Nrf2/NF-kB Signaling Pathway.

Shirooie Samira S, Heidarizade Niloofar N, Noori Tayebeh T, Sureda Antoni A et al.

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) characterized by damage to the myelin sheath and, over time, by progressive neurological disability. Statins have attracted attention in MS research owing to their anti-inflammatory and neuroprotective effects. This study assessed whether atorvastatin could ameliorate cuprizone-induced behavioral and histopathological changes in the brains of male C57BL/6 mice. All groups of mice, except the control group, which received a normal diet, were fed 0.2% cuprizone (CPZ) in their daily diet for 6 weeks to induce demyelination. The treatment groups received atorvastatin (1, 2, or 4 mg/kg/day, i.p.) or nano-atorvastatin (2 mg/kg/day, i.p.) during the final 2 weeks of the study. At the end of the study, behavioral tests were conducted, and immunofluorescence assessment of NF-kB p65 and Nrf2 in the corpus callosum was conducted. CPZ caused progressive weight loss by the end of the study compared with the control group; this effect was reversed by treatment with atorvastatin and nano-atorvastatin. All behavioral tests showed reduced motor coordination in the CPZ group (P < 0.001) compared with the control group. Administration of atorvastatin and nano-atorvastatin during the last 2 weeks reversed these motor deficits. Histopathological examination showed significant demyelination in the CPZ group, which was reversed by atorvastatin injections. Furthermore, CPZ significantly decreased Nrf2 levels (P < 0.001) and increased NF-kB p65 levels (P < 0.001) in the corpus callosum; these changes were stabilized in the atorvastatin and nano-atorvastatin groups. Atorvastatin may attenuate CPZ-induced toxicity by reducing demyelination and modulating the NF-kB p65 and Nrf2 signaling pathways.

PMID 42713419
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PubMedNeurotoxicity research2026-09-09

Atorvastatin Shows Limited Disease-Modifying Effects in an A53T α-Synuclein Mouse Model of Parkinson's Disease.

Wei Lijian L, Hua Junkai J, Tang Shuangfeng S, Lei Jianming J et al.

Neuroprotective effects of statins in Parkinson's disease (PD) remain uncertain, and their activity in genetic α-synuclein (αSyn) disease models has been insufficiently characterized. We evaluated atorvastatin (ATO) in a mouse model with nigral overexpression of human A53T-mutant αSyn. Mice received ATO by oral gavage at 10 mg/kg/day for 5 weeks and were assessed using behavioral testing, neuropathological assessment, brain transcriptomics, and molecular docking. ATO inhibited cholesterol biosynthesis-related transcriptional programs and broadly remodeled lipid metabolism-associated networks, but did not lead to functional or histopathological benefit. ATO did not ameliorate motor deficits, restore dopaminergic markers, or reduce αSyn protein levels or pSer129-αSyn immunoreactivity. Transcriptomic analysis further showed that ATO failed to reverse the core disease-associated signature induced by A53T αSyn overexpression and instead increased SNCA mRNA. Targeted RNA-seq and western blot analyses showed no parallel increase in Prkn, Gba1, or Lamp2 transcript abundance or in PARKIN, GBA1, or LAMP2A protein expression. Molecular docking, used here as an exploratory structural comparison, suggested a relatively weak predicted interaction between ATO and αSyn when compared with several other statins and provided supportive context for the lack of efficacy. Overall, our findings indicate limited efficacy of ATO in this αSyn-driven setting and support further comparative evaluation of individual statins across complementary PD models.

PMID 42714756
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PubMedForensic science international2026-09-08

Protocol-dependent variability in ⁸⁷Sr/⁸⁶Sr in human hair: A cautionary note for forensic provenancing.

Ammer Saskia T M STM, Kootker Lisette M LM

Human hair, primarily composed of the protein keratin, is one of the most frequently recovered forms of trace evidence in forensic investigations. Radiogenic strontium isotope analysis (87Sr/86Sr) of human hair shows considerable promise for forensic provenancing. However, its application remains challenging because hair contains both biogenic strontium incorporated during growth, and exogenous and diagenetic strontium acquired through environmental exposure. Existing decontamination protocols, largely developed for stable isotope analyses, have not been validated for radiogenic strontium isotope research. This experimental study evaluated the effects of 17 chemical pre-treatment protocols including acetone, methanol:chloroform (2:1), Milli-Q and 0.1 M p.a. hydrochloric acid on the 87Sr/86Sr and Sr concentrations of modern and experimentally buried human hair. The results demonstrate that chemical pre-treatment itself can alter measured 87Sr/86Sr, with the magnitude of these shifts depending on hair colour. This effect is likely related to differences in melanin content, as melanin easily binds metal cations, potentially influencing the retention and removal of strontium during chemical pre-treatment. Although the inclusion of a final Milli-Q rinse effectively recovers the biogenic 87Sr/86Sr in an experimental context, even the most complex and elaborate protocol 13 (AC-MQ-MC2-HCl-MQ) did not remove diagenetic strontium incorporated in pubic, forearm and scalp hair after burial (<14 months). These findings indicate that currently available cleaning procedures cannot reliably recover the original biogenic strontium isotope composition of buried hair and highlight the need for caution when using hair 87Sr/86Sr data for forensic provenancing.

PMID 42710300
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