Drug Database
SI

sirolimus (Excel / Excel II)

✓ Approved

JW Medical Systems · MTOR · Small Molecule

What is sirolimus?

sirolimus is a small molecule developed by JW Medical Systems. It is approved for therapeutic indications via surgical implantation.

Drug Profile

Brand NamesExcel, Excel II
CompanyJW Medical Systems
Drug ClassSmall Molecule
Molecular TargetMTOR
RouteSurgical Implantation
StatusApproved
Sources: ClinicalTrials.gov, JW Medical Systems

Mechanism of Action

Molecular Targets

sirolimus 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

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

Therapeutic AreaConditionPhase
Injury, poisoning and procedural complicationsRestenosis✓ Approved

Related Research Articles

PubMedBeijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences2026-07-24

[Cystic lymphangioma of the penis in an adult: A case report].

Yang Qingkai Q, Lu Jian J, Lu Min M, Hong Kai K

Lymphangioma is a congenital vascular malformation arising from aberrant lymphatic deve-lopment, with a reported incidence of approximately 1 in 4 000. The condition predominates in the pedia-tric population, with the head and neck representing the most frequently affected anatomical regions. By contrast, scrotal lymphangioma in adults is exceedingly rare and remains highly susceptible to misdiagnosis or diagnostic omission in clinical settings. Here, we report a case of cystic lymphangioma of the penis in a 42-year-old male who presented with a mass at the penile root persisting for over 30 years, with marked enlargement over the preceding six months. Physical examination revealed a cystic mass measuring approximately 7 cm×4 cm×5 cm on the left aspect of the penile root, with a positive transillumination sign. Bilateral testes, epididymides, and spermatic cords were unremarkable. Ultrasonography demonstrated an irregular cystic anechoic lesion at the penoscrotal junction with well-defined margins. Magnetic resonance imaging (MRI) revealed a multilocular cystic lesion at the scrotal root measuring approximately 5.6 cm×3.8 cm×6.3 cm. Both imaging modalities were consistent with cystic lymphangioma. The patient underwent complete surgical resection under epidural anesthesia. Intraoperatively, the mass was confirmed to be multilocular and contained taupe-colored fluid. Histopathological analysis revealed endothelial cell lining of the cyst wall, and immunohistochemical staining was positive for CD31, establishing the definitive diagnosis of cystic lymphangioma. Genomic profiling identified a somatic heterozygous missense mutation in the PIK3CA gene at codon E545 (GAG>GCG), consistent with the established pathogenic mechanism underlying lymphangioma. Mechanistically, somatic PIK3CA mutations activate downstream signaling cascades, driving aberrant proliferation of lymphatic endothelial cells and culminating in cystic lesion formation. Clinically, lymphangioma typically manifests as a painless, slowly enlarging cystic mass. Definitive diagnosis relies on integrated imaging and histopathological evaluation, with differential diagnoses encompassing indirect inguinal hernia, hydrocele, and varicocele. Complete surgical resection remains the first-line therapeutic strategy and is associated with a substantially reduced recurrence rate. For patients deemed ineligible for surgery, sclerotherapy or molecularly targeted agents, including sirolimus and alpelisib, represent viable alternatives. The patient achieved an uneventful postoperative recovery with no evidence of recurrence at one-month follow-up. Although adult scrotal cystic lymphangioma is a rare clinical entity, it exhibits characteristic clinical, radiological, and pathological features that, in conjunction with molecular genetic analysis, enable accurate diagnosis. Early complete resection confers a favorable prognosis. Heightened clinical awareness and standardized management of lymphangioma at atypical anatomical sites are warranted.

PMID 42493458
Read full article →
PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-07-22

Tacrolimus combined with everolimus versus sirolimus in organ transplantation: a comparative pharmacovigilance analysis of the FDA Adverse Event Reporting System.

He Yanlang Y, Luo Chen C, He Shuangyan S, Li Sha S et al.

To compare the adverse event reporting profiles of tacrolimus combined with everolimus versus tacrolimus combined with sirolimus for immunosuppressive therapy after organ transplantation using the FDA Adverse Event Reporting System (FAERS) database and to generate hypotheses to inform the individualized selection of mTOR inhibitors. As FAERS does not record drug dose, the two combinations are compared without reference to tacrolimus dosing. Adverse event reports from the FAERS database spanning the first quarter of 2004 to the fourth quarter of 2025 were extracted. Disproportionality analysis was performed using four methods: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM). Analyses were conducted at the system organ class (SOC) and preferred term (PT) levels, as well as age-stratified (< 60 years vs. ≥ 60 years), sex-stratified, and time-to-onset analyses. A total of 3101 reports for tacrolimus combined with everolimus (ta_ev) involving 13,237 adverse events, and 3093 reports for tacrolimus combined with sirolimus (ta_si) involving 13,356 adverse events were retrieved. The ta_ev regimen generated 459 PT signals covering 25 SOCs, with the three strongest SOCs being renal and urinary disorders (ROR = 4.85), infections and infestations (ROR = 3.55), and blood and lymphatic system disorders (ROR = 3.48). The ta_si regimen generated 413 PT signals also covering 25 SOCs, with the three strongest SOCs being immune system disorders (ROR = 5.22), renal and urinary disorders (ROR = 3.52), and blood and lymphatic system disorders (ROR = 2.98). Both regimens generated strong renal/urinary and haematological disproportionality signals, but the reporting patterns diverged in several respects: the ta_ev regimen had a significantly stronger signal for hepatobiliary disorders (ROR = 3.12 vs. 1.89), whereas the ta_si regimen showed a stronger signal for cardiac disorders (ROR = 1.14 vs. 0.81) and a stronger association with wound healing complications. A formal between-regimen comparison (ratio of reporting odds ratios (rROR), with 95% CIs) indicated that these differences in reporting were statistically distinguishable (Table 5), although the magnitudes were modest for the cardiac and several other classes. Age-stratified analysis indicated that patients under 60 years of age had a higher frequency and greater variety of adverse events; male patients accounted for a higher proportion of reports in both groups. The median time to adverse event onset was approximately 3-3.5 months, but more than 10% of events occurred after one year of treatment. Tacrolimus combined with everolimus and with sirolimus show distinct adverse event reporting profiles in FAERS: the everolimus-based combination was relatively enriched for hepatobiliary, BK-related renal and infectious events, and the sirolimus-based combination for cardiac, immune system, and wound healing events. These disproportionality signals describe reporting rather than measured risk and are hypothesis-generating; they require confirmation in controlled studies before they can guide the individualized choice of an mTOR inhibitor, with closer monitoring suggested for recipients under 60 years of age and for male patients.

PMID 42484863
Read full article →
PubMedAdvances in pediatrics2026-07-22

Updates on Lymphatic Malformations: Medical Therapies, Sclerotherapy, and Surgery.

Hough Michelle M, Anselmo Dean D

Lymphatic malformations represent a diverse group of congenital lymphatic disorders whose management has evolved dramatically with the advent of molecularly targeted therapies. Recognition of the PI3K/AKT/mTOR signaling pathway as a key driver of pathogenesis has transformed treatment, with sirolimus and alpelisib now complementing traditional procedural options. Successful management demands multidisciplinary collaboration, integrating medical, interventional, and surgical involvement and expertise. Continued research into genotype-driven therapy, biomarker development, and long-term outcomes will further refine care for this complex and heterogeneous disease.

PMID 42481095
Read full article →
PubMedHeart (British Cardiac Society)2026-07-21

Drug-coated balloons versus drug-eluting stents for de novo coronary lesions: a systematic review and meta-analysis of randomised trials.

Mondragon Diego D, Garin Dorian D, Cook Stéphane S, Knapp Guido G et al.

Drug-coated balloon (DCB) angioplasty has emerged as a potential stent-free strategy for percutaneous coronary intervention (PCI) in de novo coronary artery disease, but robust randomised evidence on safety and efficacy compared with drug-eluting stents (DES) remains limited. We conducted a comprehensive systematic review and meta-analysis of randomised controlled trials comparing DCB angioplasty with DES for de novo coronary lesions in adult patients reporting clinical outcomes at ≥9 months. PubMed, Embase and Cochrane CENTRAL were searched from inception to October 2025 without language restriction; trial registries and reference lists were screened manually. Studies limited to in-stent restenosis, bifurcation PCI or observational designs were excluded. Data were extracted independently by two reviewers. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models (DerSimonian-Laird method with Hartung-Knapp adjustment). Heterogeneity was assessed with I² and τ² statistics and 95% prediction intervals were reported. Risk of bias was appraised with the Cochrane Risk of Bias 2 tool. Seven trials encompassing 7138 patients (DCB 3570; DES 3568) were included. At 12 months, the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and target lesion revascularisation) showed no difference between strategies (RR 1.02, 95% CI 0.63 to 1.64; p=0.93; I²=52%). Secondary outcomes were comparable: cardiac death (1.26, 0.75 to 2.14), target vessel MI (0.71, 0.36 to 1.39), target lesion revascularisation (1.09, 0.52 to 2.30) and target vessel revascularisation (0.98, 0.58 to 1.65). Sensitivity analysis supported the stability of the primary findings. Trials using sirolimus coated balloons demonstrated similar results. DCB angioplasty shows comparable short-term safety and efficacy to modern DES for de novo coronary disease. Long-term follow-up is necessary to confirm whether avoidance of permanent implants translates into clinical benefit. CRD420251175063.

PMID 42476907
Read full article →
PubMedCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2026-07-20

Ticagrelor Induced 2:1 Atrio-Ventricular Block After Percutaneous Coronary Intervention to Right Coronary Artery.

Arora Siddhant S, Sharma Yash Paul YP, Panda Prashant P, Verma Samman S

Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is standard following PCI. Ticagrelor is increasingly preferred due to its potent, reversible platelet inhibition. While generally safe, ticagrelor has been associated with conduction abnormalities, including sinus pauses and atrioventricular (AV) block, though clinically significant bradyarrhythmias remain rare. We report a rare case of symptomatic 2:1 Mobitz type II AV block following ticagrelor initiation post-PCI and emphasize the importance of timely recognition to avoid unnecessary pacemaker implantation. We describe a 68-year-old woman presenting with unstable angina. Coronary angiography revealed significant mid-RCA disease, and PCI with a sirolimus-eluting stent was performed successfully. She was discharged on aspirin and ticagrelor, without rate-limiting drugs, as her baseline heart rate was 60 bpm. Two weeks later, she developed dizziness and dyspnea (NYHA III). ECG showed 2:1 Mobitz type II AV block with a ventricular rate of 40 bpm. Repeat angiography confirmed a patent stent, and thyroid profile was normal. Holter monitoring corroborated persistent AV block. Ticagrelor was discontinued and replaced with clopidogrel, resulting in the restoration of sinus rhythm. On follow-up, the patient remained asymptomatic with normal ECG findings. Ticagrelor can rarely induce clinically significant AV block even in the absence of other rate-limiting drugs. Clinicians should maintain a high index of suspicion when post-PCI patients on ticagrelor present with bradyarrhythmias. Withdrawal of ticagrelor should be considered before resorting to pacemaker implantation, thereby preventing unnecessary interventions.

PMID 42473025
Read full article →
PubMedTherapeutic advances in cardiovascular disease2026-07-19

Two-year real-world outcomes of coronary drug-coated balloon therapy: a retrospective comparative study of sirolimus- and paclitaxel-coated devices.

Alıç Enes E, Niang Mohamed M, Tüner Haşim H, Onaç Mehdi M et al.

Drug-coated balloons (DCBs) represent a "leave-nothing-behind" strategy in percutaneous coronary intervention (PCI), particularly for small vessel disease and in-stent restenosis. However, long-term comparative real-world data between paclitaxel- and sirolimus-coated balloons remain limited, and the impact of lesion characteristics on outcomes is not fully understood. This study aimed to evaluate the 2-year clinical outcomes of coronary DCB therapy and compare the performance of sirolimus- and paclitaxel-coated balloons in a real-world cohort. Single-center retrospective cohort study. A total of 92 consecutive patients who underwent DCB-based PCI between January 2020 and December 2022 were retrospectively analyzed. Patients were grouped according to DCB type (sirolimus vs paclitaxel). The primary endpoints were restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and TLR. Secondary outcomes included changes in angina frequency and severity, and selected laboratory parameters. Outcomes were assessed over 24-month follow-up period. The overall 2-year restenosis rate was 13.0%, with TLR occurring in 7.6% of patients, and MACE in 9.8%. Significant improvements in angina frequency and severity were observed at 3 months (both p < 0.001). C-reactive protein (CRP) levels decreased during follow-up (p = 0.01). Patients with diabetes had numerically higher rates of restenosis (15.0% vs 11.0%) and MACE (12.5% vs 9.6%) compared with nondiabetic patients, although differences were not statistically significant. Similarly, sirolimus-coated balloons were associated with lower rates of restenosis (11.7% vs 15.6%) and TLR (6.7% vs 9.4%) compared with paclitaxel-coated balloons, without statistical significance. Larger vessel diameter was associated with an increased risk of restenosis (p = 0.004). In this real-world cohort, coronary DCB therapy was associated with acceptable 2-year clinical outcomes and significant symptom improvement. Although sirolimus-coated balloons showed numerically favorable results, no definitive conclusions regarding superiority can be drawn. Larger prospective studies are needed to confirm these findings and to better define optimal patient and lesion selection. Not applicable.

PMID 42470266
Read full article →

+9996 more articles available with a free account

Sign up free to view all articles →

Ask about sirolimus