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eribulin mesilate (Ailelin)

✓ Approved

Sino Biopharmaceutical Co., Ltd · Small Molecule · Small Molecule

What is eribulin mesilate?

eribulin mesilate is a small molecule developed by Sino Biopharmaceutical Co., Ltd. It is approved for therapeutic indications via injectable (others).

Drug Profile

Brand NamesAilelin
CompanySino Biopharmaceutical Co., Ltd
Drug ClassSmall Molecule
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, Sino Biopharmaceutical Co., Ltd

Therapeutic Indications

eribulin mesilate is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved

Related Research Articles

PubMedThe American journal of case reports2026-11-11

Primary Synovial Sarcoma of the Thyroid Gland Presenting With Early Pulmonary Metastasis: Diagnostic Pathway, SS18 Gene Fusion Confirmation, and Clinical Course.

Edwards Andrew G AG, Petroski Jack J, Patel Raj R, Koyfman Sergey S

BACKGROUND Primary synovial sarcoma of the thyroid gland (PSST) is an exceptionally rare and aggressive neoplasm. Twenty-one cases have been reported in the literature to date, making this the 22nd reported occurrence. This report presents the case of a 47-year-old woman with PSST confirmed by SS18 gene fusion on fluorescence in situ hybridization (FISH), who subsequently developed pulmonary metastasis and doxorubicin-induced congestive heart failure, illustrating the aggressive clinical course of this entity. CASE REPORT We report the case of a 47-year-old woman presenting with dysphagia and a left-sided neck mass. Initial FNA was non-diagnostic; repeat FNA raised concern for a spindle cell neoplasm. Left hemithyroidectomy was performed with negative margins, and SS18 gene fusion was confirmed by FISH, establishing the diagnosis of PSST. Following multidisciplinary review, adjuvant chemotherapy was deferred and neck radiation was administered. Pulmonary metastasis was discovered 6 months postoperatively. The patient received eribulin mesylate and subsequent palliative doxorubicin, and her case was complicated by doxorubicin-induced congestive heart failure. She subsequently developed progressive systemic metastatic disease, including brain and bone involvement, and died of the disease 65 months after initial presentation. CONCLUSIONS This case demonstrates that SS18 FISH confirmation is essential when FNA is non-diagnostic for a thyroid spindle cell mass. Despite negative margins and adjuvant radiation, early pulmonary metastasis and ultimately fatal systemic metastatic disease to the brain and bone occurred, underscoring the aggressive clinical course of PSST. Doxorubicin-induced cardiac toxicity further illustrates the systemic therapy burden. BCL-2-directed strategies remain investigational. Complete surgical resection with negative margins is the cornerstone of management.

PMID 43010634
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PubMedFrontiers in immunology2026-11-05

Eribulin mesylate in combination with ivonescimab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer(EMIT): study protocol for a single-arm, multicenter clinical trial.

Lu Haiqi H, Wang Xufei X, Wang Zhuo Z, Chen Miaoqin M et al.

Advanced triple-negative breast cancer (TNBC) has an extremely poor prognosis, and current therapies offer limited benefits for patients with low programmed cell death ligand 1(PD-L1) expression. This study innovatively proposes a "novel chemotherapy + bispecific antibody" model. Eribulin Mesylate (hereinafter referred to as Eribulin), a novel microtubule inhibitor, kills tumor cells while remodeling the tumor microenvironment. When combined with the PD-1/VEGF bispecific antibody Ivonescimab, it concurrently dismantles immunosuppression and angiogenesis to synergistically overcome immunotherapy resistance. This is a multicenter, open-label, single-arm clinical trial designed to enroll 29 patients with locally advanced or metastatic TNBC who have not received prior systemic anticancer therapy, and who are either ineligible for radical surgical resection or local therapy, or have experienced disease progression following postoperative adjuvant therapy. The primary endpoint is the objective response rate (ORR) assessed by Investigator Assessment (INV) at each participating center based on strict adherence to Response Evaluation Criteria in Solid Tumors version 1.1(RECIST v1.1) criteria. Secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. Exploratory endpoints involve potential biomarkers, the correlation between PD-L1 expression and efficacy, and patient-reported outcomes (PROs). This combination regimen is expected to leverage the synergistic advantages of "chemotherapy-promoted immunity and potent bispecific antibody efficacy," providing novel evidence-based medical evidence for the first-line treatment of metastatic TNBC and thereby effectively addressing significant unmet clinical needs. http://www.chictr.org.cn/, identifier ChiCTR2600117652.

PMID 42984708
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PubMedFrontiers in medicine2026-11-05

Meta-analysis of the effect of nafamostat mesilate versus no-anticoagulation regimens in adult patients undergoing continuous renal replacement therapy.

Wang Yao Y, Du Xiaoli X, Wen Dan D, Xu Rong R et al.

Continuous renal replacement therapy (CRRT) is a critical treatment for critically ill patients with acute kidney injury. However, effective anticoagulation of the extracorporeal circuit remains a clinical challenge. Nafamostat mesilate (NM), a serine protease inhibitor, possesses localized anticoagulation properties; however, its efficacy and safety in high-bleeding-risk populations have not been systematically evaluated. To compare the efficacy and safety of NM anticoagulation and no-anticoagulation regimens in patients undergoing CRRT. Randomized controlled trials (RCTs) and cohort studies were retrieved from PubMed, Web of Science, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, Wanfang Database, Chinese National Knowledge Infrastructure, and the Chinese Biomedical Literature Database. We included studies on adult patients receiving CRRT where the intervention and control groups were treated with NM anticoagulation and no-anticoagulation regimens, respectively. Primary outcomes included filter lifespan, number of filters used, coagulation indicators, bleeding events, and in-hospital mortality. The meta-analysis was conducted using RevMan 5.4 software. Eight studies involving 969 patients were included. The meta-analysis demonstrated that, compared with the control group, the NM group had a significantly prolonged filter lifespan (P = 0.01) and a reduced number of filters used (P < 0.0001). The activated partial thromboplastin time (P = 0.89), prothrombin time (P = 0.88), and international normalized ratio (P = 0.60) showed no significant differences. Both groups demonstrated clinically similar risks of bleeding events (P = 0.53). However, the NM group demonstrated a significantly reduced in-hospital mortality, compared with the control group (P = 0.02). The NM anticoagulation regimen effectively extended the CRRT filter lifespan, reduced resource consumption, and improved patient survival outcomes without increasing the bleeding risk, demonstrating particular value for high-bleeding-risk populations. Future multicenter RCTs are warranted to validate applicability of NM in non-East Asian populations. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261399024, identifier: PROSPERO CRD420251077578.

PMID 42985103
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PubMedJournal of visualized experiments : JoVE2026-10-31

Efficacy and Safety of Nafamostat Mesilate Injection in Patients Receiving Continuous Renal Replacement Therapy: A Meta-Analysis.

Tu Yanting Y, Hu Yuanmin Y, Lv Qun Q, Zhu Qinyan Q et al.

The objective of the study was to assess the efficacy and safety of nafamostat mesilate injection in patients receiving continuous renal replacement therapy (CRRT). Dichotomous and continuous outcomes were analyzed using fixed-effect or random-effects models to estimate odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs). Eight studies involving 1,189 patients were included in the meta-analysis. Compared with no anticoagulation, nafamostat mesilate injection was associated with lower mortality (OR, 0.58; 95% CI, 0.44-0.76; p < 0.001) and longer filter lifespan (MD, 7.00; 95% CI, 1.50-12.50; p = 0.01). These estimates were derived predominantly from nonrandomized studies and should be interpreted with caution. However, no significant difference was found between nafamostat mesilate injection and no anticoagulation in bleeding complications (OR, 1.09; 95% CI, 0.51-2.34; p = 0.82), total duration of CRRT (MD, 4.46; 95% CI, -0.13-9.04; p = 0.06), the proportion of patients requiring transfusion (OR, 0.75; 95% CI, 0.54-1.03; p = 0.07), and intensive care unit (ICU) length of stay (MD, -0.24; 95% CI, -3.85-3.37; p = 0.90) in patients receiving CRRT. The available evidence suggests that nafamostat mesilate injection may be associated with lower mortality and longer filter lifespan compared with no anticoagulation in patients receiving CRRT. However, no clear difference was observed in bleeding complications, total duration of CRRT, the proportion of patients requiring transfusion, or ICU length of stay. These findings are limited by the predominance of nonrandomized designs, small numbers of studies, and substantial heterogeneity. Additional adequately powered randomized studies are needed before clinical benefit can be considered established.

PMID 42965335
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PubMedLancet (London, England)2026-10-26

Izalontamab brengitecan for HR+/HER2- breast cancer in China (PANKU-Breast01): a randomised, phase 3 trial.

Lan Bo B, Shi Yehui Y, Shao Xiying X, Wu Fan F et al.

Patients with heavily pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer have few treatment options. Izalontamab brengitecan (iza-bren) is a first-in-class, epidermal growth factor receptor and HER3 bispecific antibody-drug conjugate that contains a potent topoisomerase I inhibitor payload (Ed-04). The aim of PANKU-Breast01 was to compare the efficacy and safety of iza-bren versus chemotherapy in patients with pretreated HR+/HER2- breast cancer. In this randomised, phase 3, open-label, multicentre study in 72 hospitals in China, patients with HR+/HER2- breast cancer who had disease progression after endocrine therapy, cyclin-dependent kinase (CDK) 4/6 inhibitors, and one or two lines of chemotherapy were randomly assigned (1:1) to iza-bren (2·5 mg/kg, administered by intravenous infusion on day 1 and day 8 every 3 weeks) or physician's choice chemotherapy (eribulin, 1·4 mg/m2; vinorelbine, 25 mg/m2; or gemcitabine, 1000 mg/m2, all administered by intravenous infusion on day 1 and day 8 every 3 weeks; or capecitabine, 1000-1250 mg/m2, administered orally twice daily on days 1-14 of each 3-week cycle). Stratified block randomisation was performed by an independent vendor using an interactive web response system, with stratification factors of number of previous lines of chemotherapy, CNS metastasis, and HER2 expression status. Patients, investigators, and site personnel involved in patient care and performing trial procedures were not masked to treatment assignment. The primary endpoint was progression-free survival assessed by Blinded Independent Central Review per RECIST (version 1.1) in the modified intention-to-treat population, which consisted of all randomly assigned participants who had at least one dose of study drug. Median progression-free survival was estimated using the Kaplan-Meier method and hazard ratios (HRs) were calculated using a stratified Cox proportional hazards model. The trial was registered at ClinicalTrials.gov, NCT06343948, and is closed to recruitment. Between April 24, 2024, and June 6, 2025, 560 patients were screened, 177 were excluded, and 383 patients were randomly assigned and treated (190 were assigned to the iza-bren group and 193 were assigned to the chemotherapy group). All 383 participants in the study were female and of Chinese ethnicity. Median age was 54·0 years (IQR 47·0-60·0). At data cutoff (July 21, 2026), median follow-up for progression-free survival was 15·2 months (95% CI 13·9-16·8). Iza-bren significantly improved progression-free survival versus chemotherapy (log-rank p<0·0001), and median progression-free survival assessed by Blinded Independent Central Review was 8·2 months (95% CI 6·9-8·6) versus 4·0 months (2·9-4·3; HR 0·41 [95% CI 0·33-0·53]). Grade 3 or higher treatment-related adverse events occurred in 162 (85%) patients in the iza-bren group versus 127 (66%) patients in the chemotherapy group, and haematological adverse events were the most common in both groups. For the treatment of haematological adverse events, 138 (73%) patients in the iza-bren group received platelet-elevating agents, 28 (15%) patients in the iza-bren group received platelet transfusion, and 18 patients (10%) in the iza-bren group received a blood transfusion. Two patients in the iza-bren group died due to treatment-related adverse events. Iza-bren showed a significant improvement in progression-free survival versus chemotherapy in patients with HR+/HER2- breast cancer previously treated with endocrine therapy, CDK4/6 inhibitors, and one or two lines of chemotherapy (including taxanes). The overall survival data were immature, and an overall survival benefit has not been established. These results suggest that iza-bren could be a new treatment option for this population in China; however, further evaluation of iza-bren in global populations and in earlier lines of therapy for HER2-negative breast cancer is warranted. Baili-Bio (Chengdu) Pharmaceutical, CAMS Innovation Fund for Medical Sciences, Noncommunicable Chronic Diseases-National Science and Technology Major Project, National High Level Hospital Clinical Research Funding, and the National Natural Science Foundation of China.

PMID 42933459
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PubMedJournal for immunotherapy of cancer2026-10-23

Sintilimab plus eribulin and carboplatin in patients with metastatic triple-negative breast cancer (SECURE): a phase II, multicenter trial.

Ni Mengqian M, Zhou Lijia L, Zhang Lulu L, Su Yanhong Y et al.

PMID 42919625
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