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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

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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PubMedMaterials today. Bio2026-06-03

Core-shell microneedles Co-loaded with simvastatin and doxycycline for combined anti-infection and osteogenesis in diabetic periodontitis.

Zhang Shengdan S, Zhang Wen W, Wang You Y, Yin Miao M et al.

Diabetic periodontitis remains a formidable clinical challenge characterized by persistent infection, oxidative stress, and impaired alveolar bone regeneration. Here, we have developed an engineered core-shell microneedle (MN) patch that enables the staged release of doxycycline and simvastatin to achieve coordinated antibacterial and osteogenic effects within periodontal lesions. The outer polyvinyl alcohol (PVA) shell rapidly dissolves upon insertion into gingival tissue, enabling burst release of doxycycline for immediate bacterial eradication. Subsequently, the polyvinylpyrrolidone (PVP) core, loaded with simvastatin-encapsulated polydopamine nanoparticles (Sim@PDA NPs), provides sustained release, leveraging the intrinsic reactive oxygen species (ROS)-scavenging capacity of PDA to mitigate local oxidative stress and promote osteogenic differentiation. A silk fibroin backing layer ensures long-term doxycycline release, preventing bacterial recolonization and maintaining a regenerative microenvironment. In vitro, Doxy/SIM-MNs exhibited potent antibacterial and antibiofilm activity against Porphyromonas gingivalis and Staphylococcus aureus, excellent cytocompatibility, and robust induction of alkaline phosphatase activity, mineralized nodule formation, and osteogenic gene expression in mesenchymal stem cells. In a rat model of diabetic periodontitis, Doxy/SIM-MNs markedly reduced inflammatory destruction, enhanced alveolar bone regeneration, and reestablished periodontal homeostasis by relieving negative regulation of Wnt signaling while suppressing NF-κB signaling and apoptosis. This hierarchically staged microneedle platform offers a clinically translatable strategy for the integrated management of infection, inflammation, and bone regeneration in diabetes-associated periodontitis and other chronic inflammatory bone diseases.

PMID 42231919
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