Drug Database
FI

fimasartan + rosuvastatin (Tubero / Tuvero)

✓ Approved

Boryung · AGTR1 · Small Molecule

What is fimasartan + rosuvastatin?

fimasartan + rosuvastatin is a small molecule developed by Boryung. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesTubero, Tuvero
CompanyBoryung
Drug ClassSmall Molecule
Molecular TargetAGTR1, HMGCR
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Boryung

Mechanism of Action

Molecular Targets

fimasartan + rosuvastatin acts on 2 molecular targets:

AGTR1angiotensin II receptor type 1 (HAT1R, AT1)
HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

fimasartan + rosuvastatin is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Vascular disordersHypertension✓ Approved
Metabolism and nutrition disordersHyperlipidaemiaPhase III

Related Research Articles

PubMedBMJ open2026-07-16

Effects of China's National Volume-Based Procurement policy on utilisation and affordability of statins in children: an interrupted time series analysis.

Wu Yongyi Y, Bai Wei W, Liu Fanyu F, Fan Xiaohan X et al.

Statins are effective in lowering lipids and reducing cardiovascular risk. In recent decades, rising paediatric lipid levels, especially in low- and middle-income countries (LMICs), have led to growing demand for lipid-lowering drugs. However, access remains limited in LMICs due to financial constraints. To address this, China launched its National Volume-Based Procurement (NVBP) policy in 2019, significantly improving the price and affordability of statins. This study evaluates the policy's impact on statin use and expenditures in children. The study used interrupted time series regression to analyse all levels of children's hospitals across the country's monthly procurement records of statins, covering the period from January 2019 to December 2020. It investigated the fluctuations in monthly drug procurement quantity (measured in defined daily doses) and expenditures (affordability) at both the national level and across different tiers of child medical facilities. Following the implementation of the NVBP policy, the utilisation and affordability of statins across all children's hospitals nationwide exhibited a positive upward trend. After the NVBP policy, the affordability of atorvastatin in children's hospitals nationwide improved by at least 90.54% and the affordability of rosuvastatin in children's hospitals nationwide increased by no less than 89.85%. Both before and after the NVBP policy, the majority of utilisation and expenditure in statin was contributed by atorvastatin and rosuvastatin. After the NVBP policy, the utilisation of atorvastatin and rosuvastatin bid-winning generic has increased significantly, making bid-winning generic change from the variety occupying the least market to the variety occupying the most market in children's hospitals. The implementation of China's NVBP policy has resulted in a marked increase in the dosage of atorvastatin and rosuvastatin, while effectively reducing cost expenditure for children. This achievement has been realised without compromising the quality of healthcare services. China's NVBP policy provides a reference and path for the medical reform of all countries in the world especially LMICs.

PMID 42457426
Read full article →
PubMedBJGP open2026-07-16

Understandability of statin patient information leaflets in the UK: a mixed-methods cross-sectional evaluation.

Rao Diya D, Dickson Jon M JM, Sudbury Mia M, Dixon William W et al.

Statins are the UK's most prescribed medicine and are used more in deprived populations. Patient Information Leaflets (PILs) included in medication packaging may support safe, effective use, but only if they are understandable. Guidance states PILs should have a reading age of ≤13-years, and regulators require that ≥80% of patients answer comprehension questions correctly on them when 'user tested'. To provide the first independent evaluation of the readability and comprehension of UK statin PILs. Study 1: Cross-sectional analysis of the reading age of 39/40 of the UK's approved statin PILs. Study 2: Cross-sectional survey with a representative sample of 517 UK adults aged 40-74. Study 1: Reading age was assessed using four readability formulas, with additional scores calculated after adjusting for potentially familiar technical terms. Study 2: Two PILs (atorvastatin [MSN] and rosuvastatin [Ranbaxy]) were randomly selected and user tested with participants. They answered eight comprehension questions per PIL; responses were double-scored. Study 1: No PIL met the recommended reading age. Median reading age was 15.9 years (15.0 after adjustment). Atorvastatin PILs were least readable. Study 2: Key messages were poorly understood; for atorvastatin, 5/8 items met the≥80% criterion; for rosuvastatin, 2/8 met it. Key safety and use messages were frequently misunderstood. UK statin PILs do not meet recommended readability or comprehension standards and are likely to be difficult to understand for many users. Improving clarity and usability is essential to support equitable understanding and safe, informed long-term statin use.

PMID 42457226
Read full article →
PubMedEuropean journal of clinical investigation2026-07-16

High-Intensity Statin Treatment Is Associated With Reduced Growth Differentiation Factor-15 in Patients With Coronary Artery Disease.

Stępień Konrad K, Ząbczyk Michał M, Natorska Joanna J, Zalewski Jarosław J et al.

Growth differentiation factor-15 (GDF-15) is upregulated in coronary artery disease (CAD). The relationship of intensive statin therapy with circulating GDF-15 levels has not been explored yet. In the current secondary analysis of an observational cohort, we investigated whether high-intensity statin treatment is associated with GDF-15 in patients with advanced CAD. In 102 CAD patients we measured GDF-15 levels before and after median 7 [6-8] months from initiation atorvastatin 80 mg/day (n = 63, 61.8%) or rosuvastatin 40 mg/day (n = 39, 38.2%). At the two time points we also determined C-reactive protein (CRP), thrombin generation and fibrinolysis inhibitors. There was no concurrent control group. At baseline GDF-15 levels (median 942; interquartile range 639-1284 pg/mL) were associated solely with age (R = 0.567, p < 0.001) and CRP (R = 0.464, p < 0.001), but not with lipid profile. On high-intensity statin therapy GDF-15 reduction by 17.8% was observed (p = 0.006), which was associated with CRP lowering by 46.4% (R = 0.788, p < 0.001), but not with changes in total cholesterol (by 17.6%) and low-density lipoprotein cholesterol (LDL-C) (by 28.1%). However, GDF-15 levels were lower by 28.5% (p < 0.001) and 18.9% (p = 0.013) in 43 patients (42.2%) who achieved the target LDL-C < 1.8 mmol/L and 19 (18.6%) with LDL-C < 1.4 mmol/L, respectively, as compared to the remainder. The type of statin was not associated with follow-up GDF-15. Age (p = 0.029), baseline GDF-15 (p < 0.001) and CRP (p < 0.001), but not LDL-C, were independently associated with follow-up GDF-15. We demonstrated that high-dose statin therapy is associated with lower GDF-15 in CAD patients and this effect is largely related to the anti-inflammatory properties of statins.

PMID 42460854
Read full article →
PubMedDrug development and industrial pharmacy2026-07-15

Rosuvastatin-Metformin Co-Processing: Enhanced Dissolution, Oral Bioavailability, and Therapeutic Efficacy through a Solvent-Minimized Approach.

El-Masry Soha M SM, Mostafa Shaimaa K SK, Khedr Shaimaa M SM, Abdelwahab Abeer E AE et al.

Rosuvastatin calcium (ROS) exhibits poor aqueous solubility and dissolution-limited oral absorption. This study aimed to develop an oral co-processed fixed-dose combination of ROS and metformin HCl (MET) to enhance ROS dissolution and oral bioavailability. This work highlights wet co-grinding as a simple, solvent-minimized approach for improving the biopharmaceutical performance of ROS while supporting fixed-dose combination development. Rosuvastatin/metformin (ROS/MET) co-processed systems were prepared using a solvent-minimized wet co-processing approach. The formulations were evaluated for drug content and characterized using Fourier-transform infrared spectroscopy (FTIR), powder X-ray diffraction (PXRD), thermal analysis (DSC/TGA), and scanning electron microscopy (SEM). In vitro dissolution studies were performed to assess drug dissolution behavior. In vivo Comparative pharmacokinetic evaluation in rats (n = 3 per group) assessed oral bioavailability, In vitro-in vivo correlation (IVIVC) analysis and liver biodistribution, while anti-hyperlipidemic efficacy was assessed in hyperlipidemic rats (n = 6 per group) through biochemical and histopathological analyses. The co-processed mixtures significantly enhanced rosuvastatin dissolution, with the 20:500 ROS ratio (F2) showing the best performance. Across pH 1.2, 4.5, and 6.8, F2 achieved Q5 values of 73.6%, 82.5%, and 92.7%, respectively, compared with 12.4%, 19.9%, and 28.6% for unprocessed ROS. Correspondingly, dissolution efficiency increased from 21.3-42.6% for ROS to 76.2-90.4% for F2. Comparative pharmacokinetic evaluation revealed a 21.5% increase in relative bioavailability, a 1.34-fold increase in Cmax, and a more rapid onset of action compared to unprocessed rosuvastatin. Additionally, the co-processed F2 demonstrated improved liver drug distribution and superior anti-hyperlipidemic effects in poloxamer 407-induced hyperlipidemic rats. The co-processing of rosuvastatin with metformin presents a solvent-minimized and effective strategy to enhance the dissolution, bioavailability, and therapeutic efficacy of rosuvastatin. This approach holds promise for the clinical management of complex conditions such as dyslipidemia and type 2 diabetes mellitus.

PMID 42454697
Read full article →
PubMedHealthcare (Basel, Switzerland)2026-07-15

Cost-Effectiveness of Pitavastatin in Dyslipidemia: A Systematic Review.

Vo Nam Xuan NX, Pham Huong Lai HL, Bui Tan Trong TT, Bui Tien Thuy TT

Objectives: Dyslipidemia is a major driver of cardiovascular disease (CVD), causing a global economic burden. Statins are the mainstay for reducing LDL-C, with pitavastatin (PIT) being the newest-generation statin, showing non-inferior efficacy compared with potent statins. This study aims to assess the cost-effectiveness of pitavastatin in comparison with atorvastatin (ATOR) and rosuvastatin (ROS). Method: The PubMed, Cochrane, and Embase databases were searched to identify full or partial economic evaluations through 19 November 2025. Our primary outcome is the incremental cost-effectiveness ratio (ICER), with health outcomes measured by quality-adjusted life years (QALYs) or percentage reduction in LDL-C. Regarding quality assessment, the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 tool was applied. The Revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2) checklist and Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) were performed for RCTs and non-RCT risk assessments, respectively. Result: Five studies were synthesized. One model-based analysis over a lifetime revealed that PIT was less expensive but generated slightly fewer QALYs than ATOR and was dominated by ROS. Four within-trial CEAs with follow-up ≤12 months found that for each 1% reduction in LDL-C, PIT was generally more economical than low-dose ATOR but consistently more costly than ROS. Conclusions: Because of the small number and heterogeneity of studies, it is not possible to draw firm conclusions about the cost-effectiveness of PIT. Further model-based analyses with an adequate sample size and comprehensive costing are needed to clarify the economic role of PIT.

PMID 42450861
Read full article →
PubMedFrontiers in pharmacology2026-07-13

Muscle toxicity reports in FAERS: a disproportionality analysis with focus on rhabdomyolysis and cross-database assessment.

Zhang Lei L, Wang Yuqi Y, Wang Fang F, Ji Kaiyun K et al.

Muscle toxicity can significantly impair quality of life and may be life-threatening in severe cases. Although statins are well known for their risk of muscle toxicity, a comprehensive evaluation of other implicated drugs remains limited. This study aimed to systematically characterize drug-related muscle toxicity using adverse event (AE) reports from the U.S. Food and Drug Adverse Event Reporting System (FAERS). FAERS data from the first quarter of 2004 to the fourth quarter of 2024 were extracted and processed. Signal detection was conducted using three disproportionality analysis methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN). Sensitivity analyses were conducted through stratification by sex, age, and reporter type. External validation was performed using the WHO VigiAccess database. A total of 49,289 reports related to muscle toxicity were identified, involving 47,241 cases and 220 drugs. The mean time to onset was 324.75 days, with a median of 30.00 days. Nervous system drugs accounted for the largest proportion (27.3%), followed by anti-infective agents (22.3%), and cardiovascular drugs (19.5%). The most frequently reported drugs included atorvastatin (n = 5,275), simvastatin (n = 4,831), rosuvastatin (n = 3,209), levetiracetam (n = 1,021), and quetiapine (n = 725). Several drugs not prominently described for muscle toxicity in product labeling showed disproportionality signals, including furosemide [n = 239; ROR (95%CI):3.35 (2.95-3.81)], and diazepam [n = 141; ROR (95%CI): 2.78 (2.36-3.28)]. Rhabdomyolysis was the most frequently reported and clinically significant AE. Additional signals were observed for drugs with limited or unclear labeling regarding rhabdomyolysis, including oseltamivir [n = 63; ROR (95%CI): 2.51 (1.96-3.22)], metformin [n = 397; ROR (95%CI): 2.52 (2.28-2.78)], and alprazolam [n = 178; ROR (95%CI): 2.60 (2.24-3.01)]. Sensitivity analyses and external validation showed generally consistent patterns across subgroups and databases. This study provides a comprehensive pharmacovigilance evaluation of muscle toxicity-related reports and corresponding drugs using FAERS data. Several drugs with signals not prominently described in current product labeling were identified. These findings highlight the importance of continued pharmacovigilance and may support signal detection and hypothesis generation for future research.

PMID 42440952
Read full article →

+5177 more articles available with a free account

Sign up free to view all articles →

Ask about fimasartan + rosuvastatin