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

✓ Approved

Hanmi Pharmaceutical · HMGCR · 小分子

什么是 simvastatin？

simvastatin 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simvastatin, Hanmi, simvastatin CR, Simvast CR
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

simvastatin 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

simvastatin 针对 1 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 disordersHyperlipidaemia✓ Approved

相关研究文献

PubMedInternational journal of biological macromolecules2026-06-13

Synergistic stabilization of Pickering emulsions by agar-chitosan composite particles and their potential for improving the bioavailability of lipophilic simvastatin.

Du Lipeng L, Han Xinyu X, Zhang Xingtao X, Wu Xiao X et al.

Natural biopolymer-based Pickering emulsions have emerged as promising green delivery systems for lipophilic bioactives. Agar exhibits excessive hydrophilicity with poor amphiphilic balance. Chitosan has limited solubility at physiological pH and weak independent gelation capacity. Simvastatin is a widely used lipid-lowering drug with an oral bioavailability of only about 5% due to poor aqueous solubility and gastrointestinal instability. To address these critical gaps, agar-chitosan composite particles (AGCS) were fabricated via spray-drying to stabilize Pickering emulsions for simvastatin delivery. FT-IR confirmed that electrostatic and hydrogen bonding modulated composite particle amphiphilicity. This resulted in a 97.27° contact angle and reduced interfacial tension of 13.5 mN/m. The emulsions exhibited exceptional stability at pH greater than 5 and salt levels less than 150 mmol/L. They also retained structural integrity after heat treatment up to 100 °C. This stability arose from a dual mechanism involving a dense interfacial film and a self-assembled three-dimensional gel network. Rheological analysis revealed elastic-dominated behavior supporting a 95% encapsulation efficiency at 60% oil phase fraction. In vitro digestion demonstrated that composite emulsion gels protected simvastatin from gastric degradation while enhancing bioaccessibility to 33.5% compared to free simvastatin. This work elucidates the synergistic stabilization mechanism of agar-chitosan composite particles. These particles overcome the individual limitations of native polysaccharides. The findings highlight their potential as a green biocompatible carrier for lipophilic drug delivery in biomedicine and the food industry.

PMID 42285454
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PubMedWound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society2026-06-11

Topical Statin Therapy in Wound Healing: A Systemic Review of Therapeutic Outcomes.

Stratman Scott S, Campbell Caroline C, He Helen H

This systematic review evaluates the therapeutic potential of topical statin therapy in cutaneous wound healing across in vitro and in vivo animal and human studies. A PRIMSA-guided PubMed search identified 31 eligible studies evaluating simvastatin, atorvastatin, pravastatin, rosuvastatin, or mevastatin formulated a creams, ointments, hydrogels, nanoemulgels, liposomal gels, nanosponges, films, and advanced dressing for diabetic, excisional, burn, infected, pressure, vascular, and postoperative wounds. Across models, topical statins consistently accelerated wound closure and improved histological quality through convergent mechanisms, including enhanced angiogenesis and lymphoangiogenesis, promotion of re-epithelialization, modulation of collagen deposition and extracellular matrix remodelling, and attenuation of pro-inflammatory and infectious burden. Mechanistic studies demonstrated activation of intracellular signalling pathways, upregulation of vascular endothelial growth factor and CD31, macrophage polarization, restoration of epidermal growth factor receptor signalling via caveolin-1 and glucocorticoid receptor modulation, and context-dependent regulation of collagen I/III and myofibroblast activity. Clinical data, although limited, showed some initial promise in pressure ulcers and laparotomy wound healing. Safety profiles were generally favorable, with xerosis and increased transepidermal water loss reported only at higher simvastatin concentrations. Overall, topical statins represent a promising, mechanistically rational adjunct for wound management; however, heterogeneity in wound types, formulations, dosing, and comparators, together with sparse, small clinical trials, underscores the need for rigorously designed human studies to define optimal indication, concentrations, and delivery systems.

PMID 42273908
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PubMedPakistan journal of pharmaceutical sciences2026-06-09

Nano-cocrystals of piperine-succinic acid and its antihyperlipidemic effect in male Wistar rats.

Fitriani Lili L, Hidayah Nurul N, Agustin Rini R, Badriyya Elsa E et al.

Piperine, one of the alkaloid compounds from Piper nigrum L., has been renowned for its remarkable pharmacological effects, including its antihyperlipidemic activity. However, piperine exhibits poor solubility and impairs pharmacological effectiveness. The aim of the study was to develop piperine-succinic acid nano-cocrystals and to investigate their efficacy in reducing serum cholesterol and triglyceride levels in male Wistar rats. Nano-cocrystals were prepared by the wet milling method and characterized for solid-state properties. Antihyperlipidemic activity was tested in 24 rats, which were randomly assigned into four groups: negative control group (NaCMC 0.5%), positive control group (simvastatin 0.18 mg/kgBW), intact piperine group and nano-cocrystals piperine-succinic acid group with a dose equivalent to 40 mg/kg of the body weight. Serum total cholesterol and triglyceride levels were measured enzymatically. Thermal and X-ray diffraction analyses confirmed the formation of new crystalline structures. The average particle size was 245.5 nm with a polydispersity index of 0.447 and a zeta potential value of -2.51 mV, indicating limited colloidal stability. Despite this, the nano-cocrystals significantly reduced total cholesterol and triglyceride levels compared to intact piperine (p<0.05). The duration of treatment also influenced lipid reduction (p<0.05). Although the formulation demonstrated enhanced bioactivity, further optimization of stability parameters is warranted to ensure long-term efficacy.

PMID 42262205
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PubMedMedicine2026-06-09

Drug-related pulmonary fibrosis: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System.

Jian Ruonan R, Yang Lei L, Guo Jingjing J, Shi Erxia E et al.

Pulmonary fibrosis (PF) can lead to respiratory distress, persistent dry cough, and a decline in quality of life, and may be life-threatening in severe cases. The aim is to mine and analyze drug-related PF signals, summarize potential risk medications, and provide references for clinical medication safety. This research accessed data from the US Food and Drug Administration Adverse Event Reporting System covering reports from January 2004 to September 2024. Proportional disproportionality methods were utilized to explore the relationship between drugs and PF, and to assess demographic information, drug-related PF risks, and the timing of PF onset. The Food and Drug Administration Adverse Event Reporting System database contained reports of 830 drugs associated with PF. Through disproportionality analysis and subsequent filtering, 33 drugs were identified as having significant risks. Fifteen antitumor and immunomodulatory drugs (45.45%) were noted, including bleomycin (reporting odds ratio [ROR] = 41.68), interferon gamma-1B (ROR = 12.11), and anagrelide (ROR = 6.63). Four cardiovascular system drugs (12.12%) included amiodarone (ROR = 41.92), dronedarone (ROR = 10.25), and simvastatin (ROR = 6.94). Four respiratory system drugs (12.12%) included indacaterol (ROR = 6.87), salmeterol/fluticasone (ROR = 4.30), and olodaterol (ROR = 3.76). Four antipathogenic microbial drugs (12.12%) included nitrofurantoin (ROR = 22.92), sulfasalazine (ROR = 5.69), and hydroxychloroquine (ROR = 3.51). Six other drugs (18.18%) included iodine-131 (ROR = 19.72), calcium carbonate (ROR = 8.59), and tamsulosin (ROR = 7.48). Amiodarone (Bayesian confidence propagation neural network [BCPNN] = 5.26), bleomycin (BCPNN = 4.95), and nitrofurantoin (BCPNN = 4.40) were the 3 drugs characterized by the greatest associated PF risk. The time to PF onset from antitumor and immunomodulatory drugs was significantly shorter than that from other drug types (P = .0082). The study identified 33 drugs showing disproportionality signals suggestive of potential associations with PF, most notably among antitumor and immunomodulatory agents, which exhibited a significantly shorter time to PF onset compared with other drug classes. The 3 drugs associated with the greatest PF risk were amiodarone, bleomycin, and nitrofurantoin. These findings highlight potential pharmacovigilance signals that warrant clinical vigilance and further validation through prospective studies.

PMID 42260802
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PubMedHeart & lung : the journal of critical care2026-06-06

Statin therapy and mortality in septic patients with new-onset atrial fibrillation: a retrospective database study.

Xu Dongxia D, Zhou Yucheng Y, Li Yimeng Y, Zong Gangjun G

New-onset atrial fibrillation (NOAF) significantly worsens the prognosis of sepsis, yet effective disease-modifying therapies remain limited. Statins possess pleiotropic anti-inflammatory properties that may counteract the inflammatory-arrhythmogenic cascade in sepsis. To evaluate the association between statin therapy and all-cause mortality in septic patients with NOAF and explore the impact of initiation timing, statin agent, and dosage. This retrospective cohort study utilized the MIMIC-IV database to identify septic patients with NOAF. Statin exposure was modeled as a time-varying covariate to mitigate immortal time bias. Primary outcomes were 28-day, 90-day, and 1-year all-cause mortality. Propensity score matching (PSM) and multivariable time-dependent Cox regression were employed for robustness. Among 4,392 patients, 1,327 (30.2%) received statins. After propensity score matching (n=2,654), statin therapy was independently associated with significantly reduced mortality at 28 days (HR 0.677, 95% CI: 0.589-0.779), 90 days (HR 0.678, 95% CI: 0.601-0.765), and 1 year (HR 0.690, 95% CI: 0.622-0.767; all P<0.001). The survival benefit was primarily driven by de novo initiation after ICU admission rather than chronic continuation. Agent-specific analyses revealed that simvastatin and pravastatin demonstrated the most consistent protective signals across all time points, while both low- and high-intensity regimens yielded improved survival. Statin therapy, particularly with simvastatin or pravastatin, is independently associated with improved short- and long-term survival in septic patients with NOAF. These hypothesis-generating findings support the conduct of prospective, biomarker-guided randomized trials to validate targeted statin interventions in this high-risk subpopulation.

PMID 42247832
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PubMedAmerican journal of dentistry2026-06-05

Locally delivered simvastatin and rosuvastatin in the treatment of chronic periodontitis: A systematic review and meta-analysis.

Zarei Roza R, Vatankhah Pooya P, Chaparzade Saman S, Ebrahimirad Farbod F et al.

This systematic review and meta-analysis evaluated the effectiveness of locally delivered simvastatin and rosuvastatin in the treatment of chronic periodontitis. A thorough literature review was performed utilizing PubMed, Scopus, Google Scholar, and ClinicalTrials.gov for studies published until June 2025. Titles, abstracts, and full texts of the eligible studies were obtained and reviewed. Data were subsequently extracted from the chosen studies and analyzed accordingly. A total of 30 RCT studies with 1,211 participants were included. Our study showed that the local delivery of simvastatin and rosuvastatin significantly improved pocket depth [Weighted Mean Difference (WMD) 95% confidence interval (CI)] = -0.83, -1.31 respectively, P< 0.001), clinical attachment level (-1.20, -1.59, P< 0.001), gingival index (-0.60, -1.42, P< 0.001), modified sulcus bleeding index (-0.61, -0.36, P< 0.001), plaque index (-0.38, P< 0.001), and relative attachment level (-0.54, -0.89, P< 0.001). However, there was no significant association between the plaque index and the use of rosuvastatin (-0.20, P< 0.05). The local delivery of simvastatin and rosuvastatin along with scaling and root planing significantly reduced pocket depth and improved clinical attachment level, gingival index, modified sulcus bleeding index, and relative attachment level. Further clinical trials are still required to support the results of the current meta-analysis.

PMID 42247362
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