Drug Database
BI

biolimus (biolimus, Terumo / Nobori / Nobori)

✓ Approved

Biosensors · MTOR · Small Molecule

What is biolimus?

biolimus is a small molecule developed by Biosensors. It is approved for therapeutic indications via surgical implantation.

Drug Profile

Brand Namesbiolimus, Terumo, Nobori, Nobori
CompanyBiosensors
Drug ClassSmall Molecule
Molecular TargetMTOR
RouteSurgical Implantation
StatusApproved
Sources: ClinicalTrials.gov, Biosensors

Mechanism of Action

Molecular Targets

biolimus acts on 1 molecular target:

MTORmechanistic target of rapamycin kinase (FRAP2, RAPT1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Injury, poisoning and procedural complicationsRestenosis✓ Approved

Related Research Articles

PubMedInternational journal of cardiology2026-04-19

Impacts of stent characteristics on periprocedural ischemic events in elective PCI: the ALPHEUS-stents study.

Giovachini Louis L, Ferrante Arnaud A, Guedeney Paul P, Rahoual Ghilas G et al.

Stents characteristics can have a tremendous impact on the incidence of periprocedural ischemic events following percutaneous coronary intervention (PCI) in patients with chronic coronary syndrome (CCS). The ALPHEUS-stents study aimed to describe the association between stents lengths and characteristics on the occurrence of periprocedural ischemic events. The study included patients with CCS undergoing elective PCI with at least one high-risk feature. The primary endpoint of the study was the composite of type 4a/4b myocardial infarction (MI) and periprocedural major myocardial injury evaluated at 48 h or discharge. First, we evaluated the association between total stent length and primary outcome using a multivariate logistic regression considering stent length as a continuous variable and adjusting for relevant covariates. Then we evaluated the associations between stent diameter, strut thickness, platform composition, polymer type, coating distribution and eluted drugs with the primary endpoint using a multivariable logistic regression model, with stent length categorized within the aforementioned subgroups. The primary endpoint occurred in 639 patients (35.8%). After adjustment, total stent length was significantly associated with the primary endpoint (adjusted Odds Ratio (aOR) 1.028 95%CI [1.028-1.029] per millimeter). No significant associations were observed across categories of stent diameter, strut thickness, platform composition or coating distribution. However, biolimus-eluting stents (aOR 1.051 [1.035-1.067], p = 0.006 vs other eluted drugs) were independently associated with an increased risk of the primary outcome. In patients undergoing elective PCI, the risk of periprocedural ischemic events is adequately captured by the total stent length. Biolimus-eluted stents might confer a higher risk of periprocedural ischemic events. gov number: NCT02617290.

PMID 41999954
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PubMedThe American journal of cardiology2026-03-27

Limus- Versus Paclitaxel-Coated Balloons for In-Stent Restenosis Treatment: A Systematic Review and Study-Level Meta-Analysis of Randomized Controlled Trials.

Suruagy-Motta Ricardo F O RFO, Carvalho Pedro E P PEP, da Silva Leonardo Dexheimer LD, de Oliveira Oldra Leonardo Galvão LG et al.

Drug-coated balloons are the preferred treatment for in-stent restenosis (ISR), avoiding the need for a second metallic layer. While both paclitaxel-coated balloons (PCB) and limus-coated balloons (LCB, typically sirolimus or biolimus) are used, direct comparative evidence is limited, particularly regarding their long-term angiographic efficacy and clinical safety. We conducted a systematic review and study-level meta-analyzis of studies comparing LCB with PCB for coronary ISR. A comprehensive search was performed across PubMed, Embase, Cochrane, Scopus, Web of science for randomized controlled trials. Outcomes were compared using risk ratios (RR) for categorical data and mean differences for continuous data in a random-effects model. Heterogeneity was assessed using the I2 statistic. Six randomized controlled trials involving 1,038 patients were included (552 in the LCB group and 481 in the PCB group). Compared with PCB, LCB were associated with a significantly higher risk of clinically driven target lesion revascularization (RR: 1.48; 95% CI: 1.02 to 2.14; p = 0.04; I2 = 0%) and target lesion failure (RR: 1.19; 95% CI: 0.87 to 1.62; p = 0.27; I2 = 0%). In contrast, both platforms demonstrated no differences in all-cause mortality (RR: 0.98; p = 0.96), myocardial infarction (RR: 0.73; p = 0.46), stent thrombosis (RR: 0.66; p = 0.57), or MACE (RR: 1.09; p = 0.58). Angiographic outcomes were comparable, including late lumen loss (mean differences: -0.00 mm; p = 0.65; I2 = 74.7%) and minimal lumen diameter (mean differences: -0.12 mm; p = 0.07). In patients with ISR, PCB reduced repeat revascularization compared with LCB. These data suggest a modest advantage for PCB in preventing restenosis following drug-coated balloon angioplasty for ISR.

PMID 41887557
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PubMedCirculation journal : official journal of the Japanese Circulation Society2026-03-26

Assessment of and Factors Contributing to Adequate Endothelization After Drug-Eluting Stent Implantation.

Nishino Masami M, Egami Yasuyuki Y, Nohara Hiroaki H, Kawanami Shodai S et al.

Adequate endothelization after drug-eluting stent (DES) implantation is essential to reduce thrombotic risk. Adequate strut coverage (ASC) is defined as ≥40 μm on optical coherence tomography, but its functional significance remains uncertain. Coronary angioscopy can assess neointimal function by detecting thrombus and plaque color. This study evaluated functionally adequate endothelization and contributing factors after DES implantation. Post hoc analyses of the COLLABORATION 1 and 2 studies were performed using serial optical coherence tomography and coronary angioscopy 1 and 12 months after DES implantation. Four DES types were examined: durable polymer everolimus-eluting stent (DP-EES); sirolimus-eluting stent (SES); polymer-free biolimus-coated stent (PF-BCS); and dual-therapy sirolimus-eluting stent (DTS). PF-BCS and DTS were classified as "ingenious" DES, and DP-EES and SES were classified as "fundamental." The correlation between the percentage of struts with ≥40 μm coverage (%ASC) and functional neointima (i.e., no thrombus and white plaque) was assessed. Among 150 patients (177 lesions), thrombus and yellow plaque were inversely correlated with %ASC at 12 months. Cut-off values of %ASC were 67% for thrombus prevention and 90% for plaque stabilization. Multivariable analysis identified the use of ingenious DES, prasugrel therapy, and hypertension as independent predictors of chronic adequate endothelization. Functional protection against thrombus requires %ASC ≥67%, and plaque stabilization requires ≥90%. The use of ingenious DESs and prasugrel contributes to improved chronic adequate endothelization.

PMID 41882828
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PubMedHeart & lung : the journal of critical care2026-03-20

Outcomes with limus-coated vs. paclitaxel-coated balloons for percutaneous coronary intervention: An updated meta-analysis and reconstructed time-to-event analysis of randomized controlled trials.

Sayed Mohamed Saad MS, Abdelraouf Mohamed R MR, Kedwany Ahmed M AM, Hageen Ahmed W AW et al.

Paclitaxel drug-coated balloons (DCBs) are an established option for treating coronary in-stent restenosis (ISR) and small vessel disease. However, randomized controlled trials (RCTs) comparing limus-DCBs with paclitaxel-DCBs have reported inconsistent findings. This updated meta-analysis compared clinical and angiographic outcomes of limus- versus paclitaxel-DCBs in patients undergoing percutaneous coronary intervention (PCI). Electronic databases were searched through July 2025 to identify RCTs comparing limus-DCBs with paclitaxel-DCBs in PCI. The primary outcome was target lesion failure (TLF). Summary estimates were generated using a random-effects model. Subgroup analyses were performed based on lesion type and limus agent. Ten RCTs, including 1471 patients, were analyzed. At a mean follow-up of 11.7 months, no significant difference was found in TLF (risk ratio [RR] 1.11; 95% confidence interval [CI] 0.84-1.47). Subgroup analyses showed no interaction for de novo lesions versus ISR (Pinteraction = 0.26) or for biolimus- versus sirolimus-DCBs (Pinteraction = 0.32). No significant differences were observed in major adverse cardiac events (RR 1.10; 95% CI 0.86-1.41), target lesion revascularization (RR 1.18; 95% CI 0.88-1.57), cardiac mortality (RR 0.71; 95% CI 0.25-2.04), or target vessel myocardial infarction (RR 0.71; 95% CI 0.30-1.69). Angiographic outcomes-including binary restenosis, late lumen loss, minimal lumen diameter, acute gain, net gain, and diameter stenosis-were also comparable. Among patients undergoing DCB-only PCI, there was no statistically significant difference between limus and paclitaxel-DCBs regarding clinical and angiographic outcomes. Larger RCTs with extended follow-up duration are needed to confirm these findings.

PMID 41855742
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PubMedCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2026-03-10

Long-Term Outcomes After Percutaneous Coronary Intervention With the Polymer-Free Biolimus-Coated BioFreedom Stent Versus the Biodegradable-Polymer Sirolimus-Eluting Orsiro Stent in Patients With Acute Coronary Syndromes.

Noori Manijeh M, Christiansen Evald Høj EH, Hougaard Mikkel M, Eftekhari Ashkan A et al.

The polymer-free biolimus A9-coated BioFreedom stent (BF-BCS) releases a lipophilic drug that may provide a potent anti-inflammatory effect in patients with acute coronary syndromes (ACS). Five-year efficacy and safety of BF-BCS were compared to the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent (O-SES) in ACS patients. From SORT OUT IX, 1672 ACS patients were analyzed (821 treated with BF-BCS and 851 with O-SES); 764 (46%) presented with ST-segment-elevation myocardial infarction (STEMI) and 907 (54%) with non-STEMI. Endpoints were target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction [MI], target lesion revascularization [TLR]) and definite stent thrombosis (ST) at 5-years. At 5-years, TLF in ACS patients did not differ significantly between BF-BCS and O-SES (12.5% vs. 10.8%; rate ratio (RR) 1.12; 95% confidence interval (CI): 0.84-1.49). Cardiac death, target lesion MI, and definite ST rates were similar. TLR was higher with BF-BCS compared to O-SES within the first year (2.9% vs. 1.2%, RR 2.37; 95% CI: 1.13-4.99), but this difference was not maintained at 5-year follow-up (6.2% vs. 4.3%; RR 1.42; 95% CI: 0.92-2.18). The increased risk of TLR within the first year was driven by increased risk of TLR in STEMI patients treated with BF-BCS compared to O-SES (2.5% vs. 0.3%, RR 9.96; 95% CI: 1.26-79.0), while there were no differences in TLR rates in NSTEMI patients. At 5-year follow-up, TLF did not differ significantly in BF-BCS or O-SES treated ACS patients. The increased risk of early TLR in STEMI patients treated with BF-BCS was not maintained at 5-year follow-up.

PMID 41802992
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PubMedJACC. Asia2026-03-06

Vessel Responses to Thin vs Thick Strut Polymer-Free Biolimus A9-Coated Stents.

Kusuda Masaya M, Ishihara Takayuki T, Mizote Isamu I, Nakamura Daisuke D et al.

PMID 41790099
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