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denosumab (RTPR045 / RTPR 045 / DenosteRel)

✓ Approved

Reliance Life Sciences Private Limited · TNFSF11 · 单克隆抗体

什么是 denosumab?

denosumab 是一种单克隆抗体,由Reliance Life Sciences Private Limited研发。该药已获批,用于治疗相关适应症,给药途径:Injectable (Others)、Subcutaneous Injection。

药物档案

商品名RTPR045, RTPR 045, DenosteRel
公司Reliance Life Sciences Private Limited
药物类别单克隆抗体, 抗体
分子靶点TNFSF11
给药途径Injectable (Others), Subcutaneous Injection
状态Approved

作用机制

分子靶点

denosumab 作用于 1 个分子靶点:

TNFSF11TNF superfamily member 11 (ODF, CD254)
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

denosumab 针对 2 个适应症,涉及 2 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Bone cancer✓ Approved
Musculoskeletal and connective tissue disordersOsteoporosis✓ Approved

相关研究文献

PubMedFrontiers in oncology2026-09-10

Case Report: Synergistic potential of RANKL and ACLY inhibition in a breast cancer patient with acquired resistance to CDK4/6 inhibitors.

Samusieva Anastasiia A, Gorodetska Ielizaveta I, Socha Oleg O, Lytovchenko Yuliia Y et al.

The development of acquired resistance to cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) represents a major clinical challenge in the management of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Overcoming this resistance requires novel therapeutic strategies that target the underlying molecular escape pathways. We report the case of a patient initially diagnosed in 2011 with pT2N0M0, ER+/HER2- invasive ductal carcinoma. Following multimodality treatment, she experienced disease progression with bone metastases after five years, followed by lymph node metastases at the ten-year mark. Subsequent treatment with the CDK4/6i ribociclib in combination with fulvestrant resulted in disease progression approximately one year later, indicating acquired resistance. Due to progressive bone loss, denosumab was initiated for skeletal support, and bempedoic acid was later added for dyslipidemia. This case provides a clinical basis for exploring two innovative therapeutic concepts to overcome resistance. First, we discuss the complex role of receptor activator of nuclear factor kappa-B ligand (RANKL) inhibition. Given that leucine-rich repeat-containing G protein-coupled receptor 4 (LGR4) functions as a decoy receptor for RANKL, we hypothesize that a patient's LGR4 expression status may dictate the efficacy and safety of denosumab, potentially serving as a predictive biomarker to personalize its use. Second, we propose that bempedoic acid, a supportive care medication, may exert a direct anti-neoplastic effect. Its dual mechanism, inhibiting ATP-citrate lyase (ACLY) to disrupt lipid synthesis and activating AMP-activated protein kinase (AMPK) to suppress mammalian target of rapamycin complex 1 (mTORC1) signaling, positions it as a potential agent to counteract the metabolic reprogramming associated with therapeutic resistance. This case report illustrates the sequential development of acquired therapeutic resistance in the long-term management of metastatic breast cancer. Although a single clinical observation cannot establish definitive efficacy, this scenario generates compelling hypotheses for future studies. It highlights the potential need to explore biomarker-driven approaches-such as evaluating LGR4 expression to guide RANKL inhibition-to personalize treatment. Additionally, it raises the possibility that repurposed supportive care medications, such as bempedoic acid, might offer hypothetical anti-neoplastic benefits, warranting broader clinical validation to overcome complex resistance mechanisms.

PMID 42718642
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PubMedBMJ case reports2026-09-08

Total en bloc resection of a giant cell tumour of the cervical spine involving the vertebral artery.

Uotani Koji K, Tan Ying Y, Yoshida Aki A, Misawa Haruo H et al.

A woman in her 20s presented with neck pain and was diagnosed with a primary giant cell tumour (GCT) involving the C5 vertebral body and encasing the left vertebral artery (VA). Denosumab therapy was initiated to reduce tumour vascularity and facilitate resection. After preoperative embolisation of the left VA, total en bloc resection of the tumour was performed. Postoperatively, the patient experienced transient left upper extremity weakness, which improved significantly over time. Follow-up imaging showed successful bony fusion and no recurrence. This case highlights the importance of multidisciplinary planning in managing cervical spine GCTs involving critical neurovascular structures. Combined denosumab therapy and VA embolisation can enable safe and complete tumour resection, potentially improving outcomes and reducing recurrence risk, especially in young patients.

PMID 42710959
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PubMedJournal of menopausal medicine2026-09-08

Clinical Significance of Bone Turnover Markers in Osteoporosis: Fracture Risk Assessment and Treatment Monitoring.

Kim Na Yeon NY, Chung Yun Soo YS, Seo Seok Kyo SK

Osteoporosis is a systemic skeletal disorder characterized by compromised bone strength and a higher risk of fractures. Although bone mineral density (BMD) remains the primary diagnostic measure, it has several limitations, including delayed detection of therapeutic response, restricted measurement sites, and limited sensitivity to predict fracture risk accurately. Bone turnover markers (BTMs) are noninvasive indicators of bone remodeling that are increasingly being used as complementary tools in osteoporosis assessment. Among them, serum procollagen type I N-terminal propeptide and C-terminal telopeptide of type I collagen are reference markers of bone formation and resorption. However, BTM levels can be influenced by biological and pathological factors, including circadian rhythms, food intake, and assay variability, thereby limiting their routine use as predictive markers. In individuals at risk of fracture, antiresorptive agents such as bisphosphonates and denosumab cause rapid alterations in BTMs, which correlate with long-term gains in BMD and reduced fracture risk. Monitoring BTMs can help evaluate therapeutic efficacy and adherence and complement BMD measurement in fracture risk prediction. Overall, rather than being used as stand-alone diagnostic markers, BTMs should be used as complementary tools for monitoring therapeutic responses and supporting fracture risk assessment.

PMID 42711102
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PubMedJournal of hospice and palliative care2026-09-08

Management of Cancer-Induced Bone Pain in Hospice and Palliative Care.

Lee Jae-Woo JW

Cancer-induced bone pain (CIBP) is one of the most prevalent and disabling symptoms encountered in hospice and palliative care. Bone metastases are particularly common in patients with multiple myeloma, breast cancer, and prostate cancer, and may cause continuous background pain, movement-related breakthrough pain, pathologic fracture, malignant spinal cord compression, and hypercalcemia of malignancy. CIBP results from a complex interplay of nociceptive, inflammatory, and neuropathic mechanisms driven by tumor-stroma interactions and central sensitization. Effective management requires careful differentiation between continuous background pain and movement-related incident pain. In the hospice setting, treatment must be aligned with the patient's goals of care, with an emphasis on maximizing comfort while minimizing treatment burden. Management should be grounded in systematic assessment and the WHO analgesic ladder, while recognizing that many hospice patients require early initiation of strong opioids, opioid rotation, rescue dosing, and selected adjuvant analgesics such as corticosteroids, gabapentinoids, and ketamine. Bone-modifying agents, including zoledronic acid and denosumab, can reduce skeletal-related events. A patient-centered, interdisciplinary approach, informed by the concept of "total pain," remains the cornerstone of effective bone pain management at the end of life.

PMID 42707706
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PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-09-08

Analysis of marketing authorizations, withdrawals, and refusals by the European Medicines Agency (EMA): trends in approval procedures 1995-2025.

Hitsch Florian F, Seifert Roland R

The European Medicines Agency (EMA) is an institution of the European Union (EU), responsible for the authorization and pharmacovigilance of medicinal products. In our study, we present a systematic analysis of the 1,985 centralized EMA marketing authorization procedures (MAP) between 1995 and 2025. The analysis mainly includes EMA marketing authorizations, withdrawals of marketing authorizations, and revocations of marketing authorizations or refusals of drug applications. With regard to the analysis period, it is evident that the number of marketing authorizations recommended by the EMA increased significantly between 1996 (first fully published evaluation year) and 2025. Among the active substances (International Nonproprietary Names, INNs) in centralized EMA MAPs, clopidogrel and denosumab are the most frequently represented. On the other hand, antineoplastic agents and immunosuppressants are the most common therapeutic subgroups according to the Anatomical Therapeutic Chemical Classification (ATC) in MAPs. Notably, special MAPs for medicines such as generics, biosimilars, and medicines for the treatment of rare diseases (orphan medicines) account for more than 30% of MAPs. Our analysis shows that the development of centralized EMA MAPs is influenced by multiple factors such as medical need, regulatory framework, the economic potential of medicines, and patent law considerations. Our analysis provides a comprehensive overview of these procedures and may help identify potential obstacles and opportunities for their further development.

PMID 42706333
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PubMedMedicine2026-09-06

Potent bisphosphonate therapy for preventing fractures after denosumab discontinuation in osteoporosis: A GRADE-assessed systematic review and meta-analysis.

Shah Asim A, Khan Suleman S, Rizvi Syeda Vilay Zehra SVZ, Farhan Kanza K et al.

Denosumab cessation causes rebound bone turnover, fast bone loss, and an elevated risk of vertebral fractures. Pooled data about the fracture prevention efficacy of potent bisphosphonates (BPs) as sequential therapy have been lacking to counteract this risk. This systematic review and meta-analysis was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. PubMed, Scopus, the Cochrane Library, and ClinicalTrials.gov were searched from the beginning through May 1, 2026. Included studies comprised adults with osteoporosis or low bone mass who discontinued denosumab and subsequently received potent BP therapy, defined as alendronate or zoledronic acid, compared with no subsequent antiresorptive therapy or a selective estrogen receptor modulator (SERM). Random-effects meta-analyses were performed using the Mantel-Haenszel method to calculate pooled risk ratios (RRs) with 95% confidence intervals (CIs). Prespecified subgroup analyses were conducted based on comparator type. The Grading of Recommendations Assessment, Development and Evaluation assessment method was applied to assess the certainty of the evidence. Six studies were included; 683 participants contributed to the primary incident vertebral fracture analysis. Potent BP therapy was linked to a considerable reduction in incident vertebral fractures (RR = 0.29; 95% CI: 0.14-0.59; 71% relative risk reduction), multiple vertebral fractures (RR = 0.08; 95% CI: 0.01-0.43; 92% relative risk reduction), and clinical vertebral fractures (RR = 0.18; 95% CI: 0.07-0.49; 82% relative risk reduction). The protective effect was driven mainly by comparisons with no subsequent therapy, while comparisons with SERM therapy were limited and not statistically significant. There was no statistically significant reduction in any fracture (RR = 0.35; 95% CI: 0.10-1.24) or non-vertebral fracture (RR = 0.43; 95% CI: 0.07-2.64). Overall certainty of evidence was low to very low, mainly due to the observational nature of most included studies and imprecision in several outcomes. Potent BP therapy was related to decreased vertebral fracture risk after denosumab termination, particularly when compared with no subsequent therapy. Evidence versus SERM comparators was limited and inconclusive. The results are in agreement with the present clinical guideline recommendations for sequential BP use after the discontinuation of denosumab, but further high-quality randomized trials are required to prove this.

PMID 42700089
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