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sirolimus (NPC 12G / Hyftor / rapalimus)

✓ Approved

Nobelpharma Co., Ltd. · MTOR

什么是 sirolimus？

sirolimus 是一种治疗药物，由Nobelpharma Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Topical。

药物档案

商品名NPC 12G, Hyftor, rapalimus
公司Nobelpharma Co., Ltd.
分子靶点MTOR
给药途径Topical
状态Approved
来源： ClinicalTrials.gov, Nobelpharma Co., Ltd.

作用机制

分子靶点

sirolimus 作用于 1 个分子靶点：

MTORmechanistic target of rapamycin kinase (FRAP2, RAPT1)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

sirolimus 针对 4 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Angiofibroma✓ Approved
Respiratory, thoracic and mediastinal disordersLymphangioleiomyomatosis✓ Approved
Congenital, familial and genetic disordersLymphatic malformation✓ Approved
Congenital, familial and genetic disordersNeurofibromatosisPhase III

相关研究文献

PubMedOral and maxillofacial surgery2026-07-27

Successful management of lymphangioma circumscriptum of the tongue with sirolimus monotherapy: a case report.

Salmon Allison A, Reilly Paige P, Weyh Ashleigh A, Callahan Nick N

Lymphangiomas are uncommon congenital benign tumors of the lymphatic system. They are typically diagnosed at birth and develop during the first years of life. The tongue is the most commonly affected structure in the oral cavity. Lymphangioma circumscriptum of the tongue is a common cause of macroglossia in children, and this macroglossia can lead to complications such as exclusive nasal breathing, airway obstructions, impaired oral feeding, esthetic disfigurement, and difficulties in mastication, swallowing, and speech. This report discusses the successful treatment of lymphangioma circumscriptum of the tongue with sirolimus, an immunosuppressant drug. The extent of the lesion made traditional surgical management impossible without excessive morbidity, so the patient was managed medically. This case report was unique due to its entirely nonsurgical treatment approach. The patient completed a 17-month course of sirolimus monotherapy with response to treatment monitored using T2 MRI. There was excellent response to treatment, full resolution of symptoms, and no treatment-related toxicity.

PMID 42503529
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PubMedJournal of functional biomaterials2026-07-27

Evaluation of Graphene as a Novel Bioactive Stent Coating: Comparative Performance and Vascular Response in Porcine Coronary Arteries.

Arkowski Jacek J, Sareło Przemysław P, Pasławska Urszula U, Pasławski Robert R et al.

Coronary drug-eluting stents (DESs) are the current clinical standard, yet delayed endothelialization remains a critical challenge. Graphene-based coatings have emerged as promising cardiovascular biomaterials due to their favorable hemocompatibility and ability to support endothelial cell growth. In this study, we evaluated the in vivo performance of graphene-coated stents (GCSs) compared with commercial sirolimus-eluting stents in a Polish White swine model (n = 10). Stents were implanted into major coronary branches, with follow-up at 30 and 90 days using quantitative coronary angiography (QCA), optical coherence tomography (OCT), and cryogenic scanning electron microscopy (cryo-SEM). No systemic toxicity, mortality, thrombotic events, or ischemic complications were observed during the study period. QCA demonstrated no significant differences in percent diameter stenosis between GCSs and DESs at either 30 days (12.3 ± 6.1% vs. 8.6 ± 5.8%, p = 0.2782) or 90 days (18.3 ± 10.5% vs. 9.6 ± 6.6%, p = 0.1074). OCT analysis confirmed comparable lumen and neointimal parameters between groups, while demonstrating a favorable, although non-significant, trend toward a lower percentage of uncovered struts in GCSs. Cryo-SEM imaging demonstrated stable tissue integration and a preserved healing response surrounding GCSs. Collectively, these findings indicate that GCSs are safe and biocompatible and demonstrate mid-term vascular performance comparable to clinically used DES platforms. The presented results support further investigation of graphene-based coatings as potential surface-modification strategies for coronary stents.

PMID 42506539
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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
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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
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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
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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
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