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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

PubMedJournal of geriatric cardiology : JGC2026-09-19

Safety and efficacy of low-density lipoprotein-lowering drugs in the elderly: a network meta-analysis of randomized controlled trials.

Niaga Karmenia Jessica Kurnia KJK, Supinto Pedro Arruda PA, Tjandra Kevin Christian KC, Martin Alfianto A et al.

Balancing the efficacy of low-density lipoprotein (LDL) reduction with safety presents a significant challenge in the elderly care. While guidelines recommended high-intensity statins as the optimal strategy to lower LDL in high-risk individuals, there are prevailing concerns regarding its side effects and subsequent fatality rate. The effectiveness of different LDL-lowering therapies in this population is also unclear. This study aims to compare the safety and efficacy of various LDL-lowering strategies in elderly population. A systematic search was conducted through six databases until March 2025. Randomized controlled trials (RCTs) that evaluate LDL-lowering agents were included. The primary outcome was adverse effects, while secondary outcomes included composite cardiovascular disease (CVD) events, CVD related mortality, all-cause mortality, and LDL level reduction. Risk of bias was assessed using the RoB-2 tool. A network meta-analyses were performed to compare the safety and efficacy with subgroup analysis based on underlying CVD under the cumulative ranking values. Sixteen RCTs (n = 43,625) with low to moderate risk of bias were included. Among interventions evaluated for adverse events, moderate-intensity pitavastatin had the highest probability of being the safest. Ezetimibe demonstrated the most favorable safety profile for reducing CVD mortality, while evolocumab was most effective in lowering all-cause mortality. For LDL reduction, the combination of moderate-intensity pitavastatin and ezetimibe was the most effective, followed by moderate-intensity rosuvastatin plus ezetimibe. Subgroup analyses revealed significant differences between CVD and non-CVD populations in CVD mortality (P = 0.0059), CVD events (P = 0.0096), and LDL reduction (P = 0.0100), with more pronounced effects in the non-CVD group, suggesting greater efficacy in primary prevention. Moderate-intensity pitavastatin showed the highest safety profile, while its combination with ezetimibe was the most effective for LDL reduction.

PMID 42760936
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PubMedInternational journal of cardiology. Cardiovascular risk and prevention2026-09-17

Real-world patterns in lipid profile testing and lipid-lowering therapy in hospitalized patients: The Jurasz Lipid Study.

Ostrowska Małgorzata M, Ratajczak Jakub J, Ziółkowski Marcin M, Adamski Piotr P et al.

The aim of the Jurasz Lipid Study was to provide real-world evidence on lipid profile testing, as well as the prevalence of lipid-lowering therapy (LLT) in consecutive patients hospitalized in a tertiary multi-specialist hospital in Poland. A total of 40,646 patients were hospitalized across all analyzed departments. The majority of patients hospitalized in the cardiology and neurology departments underwent lipid profile evaluation (93.6% and 95.0%, respectively), while it was rarely performed in surgical department (14.9%). Patients receiving LLT, compared with untreated patients, more frequently had a history of atherosclerotic cardiovascular disease (ASCVD) and lipid profile testing. The prevalence of LLT use ranged from 0.1% in pediatrics to 35.1% in vascular surgery, 37.1% in neurology, up to 65.7% in cardiology and 69.1% in the cardiac surgery department. Statin monotherapy remained the standard of care, with atorvastatin and rosuvastatin being the most frequently used agents. The proportion of patients receiving high-intensity statin therapy ranged from 29.2% in neurology to 71.7% among ASCVD patients in cardiology. The combination of a statin with ezetimibe was used in up to 36.1% of ASCVD patients hospitalized in cardiology. Other LLT combinations were rarely observed. Lipid profile evaluation was routinely performed by cardiologists and neurologists, but rarely ordered by surgeons. The majority of patients with ASCVD were treated with LLT, but only up to 29.4% achieve treatment goals. Statin monotherapy remained the cornerstone of LLT. Statin with ezetimibe was the most common therapeutic combination.

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PubMedJournal of controlled release : official journal of the Controlled Release Society2026-09-17

ROS-responsive bionanodrug for atherosclerosis therapy via regulating glycolipid metabolism and cell crosstalk.

Yu Jie J, Dong Xiaoyan X, Yu Feifei F, Wu Yizhou Y et al.

Atherosclerosis (AS) is a long-term inflammatory disorder marked by dysfunctional glycolipid metabolism, abnormal inflammatory response and intercellular crosstalk. Rosuvastatin (RSV), a first-line drug with lipid-lowering activity, fails to adequately modulate the inflammatory microenvironment of atherosclerotic plaques. The natural active ingredient shikonin (SKN) compensates for this limitation through inhibiting glycolysis and anti-inflammation. However, how to efficiently co-delivery them to the plaques remains challenging. In this, we engineered a ROS-responsive nanosystem (TK-MLP@SR NPs) containing SKN and RSV. This system enables drugs release in the plaque microenvironment with high ROS levels, prolongs circulation time, and achieves active lesion targeting. In vitro assay indicated the function of TK-MLP@SR NPs for inhibiting glycolysis and promoting fatty acid oxidation (FAO) in homocysteine-treated macrophages, thereby inhibiting foam cell formation and alleviating inflammation. Moreover, this nanosystem inhibited phenotype switch of vascular smooth muscle cell by restoring normal macrophage - smooth muscle cell crosstalk. In ApoE-/- mice, the accumulation of TK-MLP@SR NPs in the plaque reduced macrophage infiltration, thereby modulating the inflammatory microenvironment to restore smooth muscle cell function and improved the plaque stability, characterized by less lipid deposition, and increased collagen, along with smaller necrotic cores. Compared with free drugs, this strategy exhibited superior efficacy in regulating the plaque microenvironment by inhibiting lipid deposition. In summary, this work introduces a novel plaque environment-activated prodrug platform, providing valuable insights for clinical translation of AS therapy.

PMID 42753822
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PubMedScandinavian journal of primary health care2026-09-15

Changes in LDL-C levels among primary health care patients with hypertension, coronary artery disease, and diabetes during a 36-month follow-up.

Valkonen Petra P, Mikkonen Ulla U, Kautiainen Hannu H, Mäntyselkä Pekka P et al.

Low-density lipoprotein cholesterol (LDL-C) level is one important modifiable risk factor for cardiovascular diseases. This study aimed to describe the characteristics of primary health care patients with hypertension, coronary artery disease, or diabetes according to their LDL-C levels and to observe changes in these levels and medications during the 36-month follow-up. This study was based on a clinical trial, conducted in a health centre in Siilinjärvi, Finland, between 2017 and 2021. A total of 507 patients with hypertension, coronary artery disease, or diabetes were divided into four groups based on their baseline LDL-C levels to align with the dyslipidaemia guideline risk categories as follows: LDL-C (mmol/L) in Group 0 (< 1.4), Group 1 (1.4-1.8), Group 2 (>1.8-2.6), and Group 3 (> 2.6). The mean age at baseline was 69 years (58% females). All patients in Groups 0 and 1 already used lipid-lowering medication. A lower LDL-C level at baseline was statistically significantly associated with higher age, lower blood pressureand lower alcohol consumption. There were changes in the pharmacologically active substances prescribed in all groups. During the 36-month follow-up, the mean LDL-C values decreased statistically significantly in group 3 (-0.76 mmol/L, 95% CI -0.90 to -0.62, -21%, p < .001: [ANCOVA]). The highest increase in lipid-lowering medication prescriptions occurred within this group. This study provides a perspective on real-word treatment patterns and changes in medications prescribed as the recommendations change over time. During a period of increasing pharmacotherapeutic opportunities, this study, conducted in everyday clinical practice suggests that common lipid-lowering medications (atorvastatin and rosuvastatin) are most frequently used for primary health care patients, and are associated with a significant decrease in LDL-C levels. A greater decrease was observed among patients with higher baseline LDL-C values. Despite decreases in LDL-C, this study suggests that the gap remains between guideline-recommended treatment targets and achieved LDL-C levels.

PMID 42743594
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PubMedFrontiers in pharmacology2026-09-13

A microdose cocktail and population pharmacokinetic study suggests potentially reduced CYP3A and P-gp activities in type 2 diabetes.

Li Yafen Y, Yang Jin J, Zhou Enda E, Geng Kuo K et al.

Diabetes patients often exhibit suboptimal efficacy and adverse reactions, accompanied by pharmacokinetic (PK) changes, indicating drug-metabolizing enzymes and transporters (DMET) activities may change. This study aimed to determine whether type 2 diabetes affects DMET activities and quantify impact magnitude. Furthermore, gut microbiome, pharmacogenetic and demographic characteristics were assessed to elucidate the sources of inter-individual variability (IIV) in DMET activities. The activities of CYP3A and transporters P-gp, OATP and BCRP were evaluated in type 2 diabetes patients and healthy volunteers (HVs) following a single oral dose of five probe drugs (midazolam, dabigatran etexilate, pitavastatin, rosuvastatin, and atorvastatin). Population pharmacokinetics (PopPK) and an exploratory machine learning (ML) analysis were employed to quantify the impact of type 2 diabetes on DMET activities. Based on observed PK parameters, compared to HVs, type 2 diabetes patients exhibited increased exposure to midazolam (1.38-fold), dabigatran (1.40-fold), and atorvastatin (1.93-fold), whereas pitavastatin (0.931-fold) and rosuvastatin (1.25-fold) showed no change. PopPK analysis revealed that the mean activities of CYP3A and P-gp were potentially decreased by 23% and 27%, respectively, in type 2 diabetes patients, while no changes for OATP and BCRP. Notably, unlike the direct patient population covariate for P-gp, reduced CYP3A activity was indirectly estimated from lower Salmonella abundance. Additionally, factors such as sex, BCRP genotype, and Clostridium_XlVb partly explained the IIV in probe drugs exposure. The findings regarding altered DMET activities and identified influence factors help to identify specific drug classes that may warrant closer clinical attention in type 2 diabetes patients.

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PubMedBMC cardiovascular disorders2026-09-11

Comparative effects of atorvastatin and rosuvastatin on inflammatory biomarkers: a systematic review and meta-analysis of randomized head-to-head trials.

Omayer Abu A, Mohamed Mohamed I MI, Shahid Maryam M, Hoque Syed Mohammed Hassanul SMH et al.

Inflammation contributes significantly to cardiovascular disease progression. While both atorvastatin and rosuvastatin have anti-inflammatory effects, evidence directly comparing their effects on inflammatory biomarkers is limited and inconsistent. This study aimed to compare their effects through a meta-analysis of randomized controlled trials (RCTs). We performed a systematic review and meta-analysis of head-to-head RCTs comparing atorvastatin and rosuvastatin on inflammatory biomarkers. On August 14, 2024, we searched PubMed, Web of Science, Scopus, and CENTRAL, and subsequently searched ClinicalTrials.gov for unpublished studies. We included RCTs directly comparing the two statins and reported changes in C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), or adiponectin. Using a random-effects model, we pooled the data and reported the results as mean differences (MD) or standardized mean differences (SMD) with 95% confidence intervals (CIs). We assessed risk of bias using the Cochrane RoB 2 tool. The review protocol was registered in PROSPERO (CRD42024579712) (see the PRISMA 2020 for Abstracts checklist). A total of 35 RCTs (n = 6,148) were included. The pooled effect showed no significant difference in CRP reduction (MD: - 0.53 mg/L; 95% CI: - 1.10 to 0.05; p = 0.07; I2 = 82%). After excluding one outlier, rosuvastatin showed a greater reduction (MD: - 0.16 mg/L; 95% CI: - 0.28 to - 0.03; p = 0.01; I2 = 63%). The SMD also favored rosuvastatin (SMD: - 0.17; 95% CI: - 0.31 to - 0.04; p = 0.01). Sensitivity analysis among low risk-of-bias studies (n = 9) showed a smaller yet significant reduction (MD: - 0.08 mg/L; 95% CI: - 0.16 to - 0.01; p = 0.03). We observed no significant differences for IL-6 (n = 484; MD: - 0.82; 95% CI: - 3.02 to 1.38), adiponectin (n = 257; MD: - 1.78; 95% CI: - 4.70 to 1.14), or TNF-alpha (n = 309; MD: 0.23; 95% CI: - 0.05 to 0.52). Meta-regression identified baseline CRP, HDL, and hypertension prevalence as predictors of CRP reduction. Rosuvastatin showed a modest but statistically significant advantage over atorvastatin in lowering CRP, especially in patients with higher baseline inflammation or hypertension. Evidence for other biomarkers remains inconclusive. Tailoring statin therapy to patient profiles may optimize benefits.

PMID 42723012
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