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simvastatin (simvastatin, Hanmi / simvastatin CR / Simvast CR)

✓ Approved

Hanmi Pharmaceutical · HMGCR · Small Molecule

What is simvastatin?

simvastatin is a small molecule developed by Hanmi Pharmaceutical. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namessimvastatin, Hanmi, simvastatin CR, Simvast CR
CompanyHanmi Pharmaceutical
Drug ClassSmall Molecule
Molecular TargetHMGCR
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Hanmi Pharmaceutical

Mechanism of Action

Molecular Targets

simvastatin acts on 1 molecular target:

HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

simvastatin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHyperlipidaemia✓ Approved

Related Research Articles

PubMedFrontiers in pediatrics2026-07-17

Case Report: Successful topical simvastatin therapy in a 2-year-old girl with keratin 16-associated palmoplantar epidermal differentiation disorder.

Zhong Qingmei Q, Zhang Ying Y, Feng Zhen Z, Zhang Jinyan J et al.

Palmoplantar epidermal differentiation disorder associated with pachyonychia congenita is a rare autosomal dominant genodermatosis characterized by painful palmoplantar hyperkeratosis and nail dystrophy. Treatment options remain limited, particularly in young children, in whom systemic therapies carry safety concerns. Herein, we report a 2-year-old girl who presented with palmoplantar hyperkeratosis since 1 month of age, with progressive nail dystrophy involving all 20 nails. Whole-exome sequencing identified a hemizygous multi-exon deletion in keratin 16 (ClinVar: SUB16259296; OMIM: #167200), and orthogonal validation using amplicon-based high-throughput sequencing confirmed a 437-nucleotide deletion predicted to result in a frameshift with premature termination codon (PTC). American College of Medical Genetics and Genomics classification supported likely pathogenicity. Twice-daily application of topical 2.5% simvastatin/cholesterol cream for 11 weeks produced substantial improvement in plantar hyperkeratosis, resolution of painful fissures, and visibly improved morphology of nascent nail growth. No local or systemic adverse effects were observed. This case provides preliminary evidence that topical simvastatin may be an effective and well-tolerated therapy for keratin 16-associated palmoplantar epidermal differentiation disorder in young children, and highlights the potential importance of topical drug delivery in achieving therapeutic efficacy for this genetic subtype.

PMID 42465212
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PubMedProstaglandins & other lipid mediators2026-07-17

Evaluation of fucoidan compounds from brown algae (Sargassum polycystum C. Agardh) as anticoagulant, antihyperlipidemic and potential cardioprotective activity, in wistar rats (Rattus norvegicus) induced by a high-fat diet.

Risnovanthi Destia D, Astuti Ayun Dwi AD, Ismail Ismail I, Pla'bistoni Eka Kurnia EK et al.

Fucoidan, a marine polysaccharide, has demonstrated potential in treating cardiovascular diseases, including coronary artery disease (CAD). CAD treatment includes lowering blood coagulation, blood fat levels, and having heart-protective activity. This study aimed to evaluate the potential of fucoidan compounds isolated from brown algae (Sargassum polycystum C. Agardh) on anticoagulant effects through measurements of PT, APTT, and TT, as well as lipid profile, body weight, heart and aortic mass index, LDH, and CK-MB, as well as in Wistar rats (Rattus norvegicus). A total of 36 animals were divided into six groups. Group I received a standard diet without treatment; Group II received 0.5% CMC; Group III was treated with simvastatin at 20mg/kg BW; and Groups IV, V, and VI received fucoidan at doses of 30mg/200g BW, 40mg/200g BW, and 50mg/200g BW, respectively. Statistical analysis of the lipid profile showed that all fucoidan doses significantly reduced total cholesterol and triglyceride levels, although HDL levels were not increased. Organ weight analysis revealed a significant reduction (p < 0.05) in aortic weight in all treated groups, while no significant changes were observed in body or heart weight. Seven days of fucoidan administration also significantly reduced CK-MB and LDH serum levels (p < 0.05). In conclusion, fucoidan compounds Sargassum polycystum C. Agardh at all tested doses show potential in the treatment of CAD by lowering total cholesterol and triglyceride levels, reducing aortic weight, prolonging coagulation times (PT, APTT, and TT), and decreasing CK-MB and LDH levels.

PMID 42463035
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PubMedProbiotics and antimicrobial proteins2026-07-16

Heat-Inactivated Lactiplantibacillus plantarum H6 Potentiates Low-Dose Simvastatin Efficacy Against Hypercholesterolemia in Mice Through Gut Microbiota Modulation.

Li Yue Y, Zhou Guiqiu G, Yin Chengsheng C, Yu Xueping X et al.

Due to the limited lipid-lowering effect of statins, combined lipid-lowering strategies have attracted much attention. This study aims to explore the improvement effect of the combined intake of postbiotics and low-dose simvastatin on hypercholesterolemic mice. In this study, mice with hypercholesterolemia model were established and administrated with low-dose simvastatin + inactivated Lactiplantibacillus plantarum H6 / surface layer protein / cell-bound exopolysaccharides for 8 weeks, it was found that the combined intake of iH6 and low-dose simvastatin could improve the blood lipid level of hypercholesterolemia mice, and the intake of iH6 did not affect the efficacy of simvastatin. The combined intake of iH6 and low-dose simvastatin significantly reduced the total TC levels in the serum, liver, ileum and feces of mice, as well as the serum LDL-C level compared with simvastatin alone. Moreover, it effectively improved liver injury, decreased the levels of serum ALT, AST and TBA, and alleviated liver oxidative stress, thereby protecting the liver. Further analysis of the intestinal microbiota and metabolites revealed that iH6 combined with low-dose simvastatin significantly increased the relative abundance of Alistipes, Enterorhabdus, Lachnospiraceae_NK4A136_group, norank_o__Clostridia_UCG-014 and Prevotellaceae_UCG-001 in the mouse gut, regulated the composition of the intestinal BA pool, especially secondary BAs, and maintained the dynamic balance of cholesterol levels in the body. In addition, compared with simvastatin alone, the combined effect of iH6 and low-dose simvastatin could increase the expression of transcriptional genes such as Ugt2b38, Cyp2e1, Cyp1a1, Cyp2c29, and Scd1 in the ileum, enhance the cholesterol metabolism-related pathways, and alleviate hypercholesterolemia in mice. In conclusion, this study evaluated the relationship between postbiotics (inactivated strains) and drug combination, aiming to reduce the use of drugs and promote the possibility of postbiotics as a drug companion, laying a foundation for the development and application of postbiotics in medical fields.

PMID 42461500
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PubMedFrontiers in pharmacology2026-07-16

Simvastatin modulates sleep-wake behavior and locomotor activity in a dose-dependent manner in Drosophila.

Alsehli Ahmed M AM

Statins, including simvastatin, are widely prescribed cholesterol-lowering drugs with well-established cardiovascular benefits, yet their potential neurobehavioral effects, including sleep disturbances, remain unclear. Because sleep regulation in Drosophila melanogaster is conserved with mammals, this model provides a powerful system to investigate drug-induced behavioral changes. Given the reported neurobehavioral effects of lipophilic statins, we hypothesized that simvastatin exposure would alter sleep-wake behavior and sleep architecture in D. melanogaster. Wild-type flies were treated with simvastatin at concentrations of 0.00 (control), 0.05, 0.5, and 1.0 mM, and behavioral phenotypes were quantified. We observed a disruption of sleep architecture: 0.05 mM produced no detectable effect; 0.5 mM induced a robust insomnia-like phenotype characterized by reduced total sleep and prolonged sleep latency; whereas 1.0 mM increased arousal, enhancing wake activity and delaying sleep onset despite preserved total sleep amount. These findings demonstrate that simvastatin exerts distinct, dose-dependent effects on sleep regulation, differentially affecting sleep initiation and maintenance. Collectively, this study suggests that Drosophila may serve as a useful model for investigating the behavioral effects of simvastatin, although further studies are required to validate and extend these observations.

PMID 42460007
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PubMedPharmacoepidemiology and drug safety2026-07-15

DrugUtilisation: An R Package to Support Drug Utilisation Research Using the OMOP Common Data Model.

Guo Yuchen Y, Burn Edward E, Jödicke Annika M AM, Mercadé-Besora Núria N et al.

To develop and describe DrugUtilisation, an open-source R package that facilitates drug utilisation studies using data mapped to the OMOP Common Data Model (CDM). Core functionalities include creating drug user cohorts, identifying and summarising indications, describing the duration and dose of medication/s and assessing treatment adherence. The package works with packages developed within the DARWIN EU initiative to support study-specific workflows. We show the package's workflow by analysing the use of simvastatin in three European real-world databases. This paper outlines the DrugUtilisation package's functions and demonstrates their application with a clinical example of simvastatin use in databases from the United Kingdom, Estonia and the Netherlands. We generated results including cohort counts, indication summaries, measures of dose and duration, as well as publication-ready tables and figures. We implemented comprehensive unit tests and standardised output format, which ensured consistency across databases and minimised coding errors. The development of this software allows for researchers to quickly perform common drug utilisation analyses, while also providing the foundation for additional, bespoke study-specific analyses.

PMID 42448616
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PubMedBrain communications2026-07-13

Investigating the treatment of vascular risk with simvastatin in secondary progressive multiple sclerosis: analysis from the MS-STAT2 randomized controlled trial.

Williams Thomas T, Magill Nicholas N, John Nevin A NA, Bianchi Alessia A et al.

Vascular comorbidity is associated with more severe disability in multiple sclerosis. However, it is unknown whether treating vascular risk will lead to a disease modifying effect. Given the established role of simvastatin as a modifier of vascular risk, we aimed to investigate whether randomization to simvastatin could mitigate the relationships between serum cholesterol profiles and disease worsening, compared with placebo, in the MS-STAT2 trial. MS-STAT2 (NCT03387670) recruited 964 patients with secondary progressive multiple sclerosis, who were randomized to simvastatin (80 mg) or placebo for 3 years. 246 participants additionally underwent yearly magnetic resonance imaging (MRI). Vascular risks were systematically assessed at trial baseline. In this exploratory analysis, the relationships between cholesterol ratio (total cholesterol/high-density lipoprotein) and longitudinal clinical and MRI outcomes were assessed, comparing simvastatin to placebo groups. At baseline, median (IQR) age was 55 (50-60) years and median cholesterol ratio 3.4 (2.8 to 4.3). 73% were female, and 72% required a walking aid. Higher cholesterol ratio was associated with more severe baseline disability. No longitudinal relationships were observed between cholesterol ratio and clinical or brain atrophy outcomes. However, for each unit increase in cholesterol ratio, T2 lesion volume increased by +2.47% (95% CI: +0.03 to +4.97) from baseline in the placebo group. This relationship was significantly reduced in those randomized to simvastatin (-3.10% [-0.06 to -6.06]). Randomization to simvastatin appeared to mitigate the relationship between higher cholesterol ratios and longitudinal increases in T2 lesion volume in patients with secondary progressive multiple sclerosis. Further multi-modal interventional studies targeting vascular risk in patients with multiple sclerosis are warranted.

PMID 42440661
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