A Prospective, Single- Center, Phase IV, Interventional, Single Arm Trial for the Evaluation of Subcutaneous Recombinant Hirudin 15 mg (RB Variant) in Prophylaxis of Deep Vein Thrombosis (DVT) Post Major Orthopedic Operations

This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations

Start Date24 Nov 2022

Sponsor / Collaborator

Minapharm Pharmaceuticals

100 Clinical Results associated with Hirudin biosimilar(Rhein-Minapharm)

100 Translational Medicine associated with Hirudin biosimilar(Rhein-Minapharm)

100 Patents (Medical) associated with Hirudin biosimilar(Rhein-Minapharm)

2,405

Literatures (Medical) associated with Hirudin biosimilar(Rhein-Minapharm)

01 Mar 2025·Biomaterials

Engineering hirudin encapsulation in pH-responsive antioxidant nanoparticles for therapeutic efficacy in ischemic stroke model mice

Article

Author: Hou, Junling ; Hu, Yifan ; Nagasaki, Yukio ; Xiao, Liman ; Zhang, Peiwen ; Mei, Ting

This study introduces a novel pH-sensitive, hirudin-loaded antioxidant nanoparticle (HD@iNano^AOX) aimed at addressing the challenges of hirudin's short half-life and hemorrhagic transformation. HD@iNano^AOX was engineered to safeguard and prolong hirudin's bioactivity by encapsulating it within antioxidative nanoparticles, facilitating its gradual release in acidic environments. The efficacy of this approach was validated through both ex vivo and in vivo experiments. Ex vivo thrombolytic assays demonstrated that HD@iNano^AOX maintained effective clot lysis activity under acidic conditions. In vivo assessments revealed that HD@iNano^AOX significantly prolonged hirudin's half-life and reduced cerebral infarct volume in a mouse model of middle cerebral artery occlusion (MCAO). Furthermore, HD@iNano^AOX treatment mitigated cerebral oxidative stress, suppressed hemorrhagic transformation, and prevented blood-brain barrier (BBB) disruption. These findings suggest that the combined thrombolytic and antioxidative properties of HD@iNano^AOX offer a promising therapeutic approach for ischemic stroke. Nonetheless, further research is warranted to optimize the formulation and assess its safety and efficacy in clinical settings.

01 Nov 2024·Parasitology Research

Diversity of hirudin and hirudin-like factor genes in the North-African medicinal leech, Hirudo troctina

Article

Author: Abilov, Amina ; Müller, Christian ; Ahmed, Raja Ben

AbstractMedicinal leeches of the genus Hirudo inhabit large areas of the Palaearctic realm. The distribution range of Hirudo troctina includes the southern Iberian peninsula and the northwestern regions of Africa. H. troctina is used for medical purposes, but only very little is known about the components of its salivary gland secretion. Hirudins, bivalent inhibitors of thrombin, are probably the best known leech-derived bioactive factors. Hirudin-like factors (HLFs) represent another class of salivary gland components that share characteristic genetic and structural markers with hirudins. Hirudin is not a single entity but exists in at least four different variants. However, there are differences among the European members of the genus Hirudo with respect to the actual number of hirudin and HLF genes that are present within their genomes. Here, we describe the identification and molecular cloning of 11 genes that encode for putative hirudin and HLF variants in H. troctina. Three of the genes consist of exons and introns that originate from different “archetype” genes and are likely the result of recombination events. The diversity of hirudin and HLF genes in H. troctina surpasses that of all other European members of the genus Hirudo. The putative hirudin variants and representatives of the HLFs of H. troctina were expressed as recombinant proteins, purified and functionally characterized for their thrombin-inhibiting potencies. Phylogenetic analyses based on hirudin and HLF gene sequences of the leech genera Hirudo, Hirudinaria, and Whitmania supported the hypothesis that hirudins and HLFs diverged early in leech evolution.

01 Oct 2024·Naunyn-Schmiedeberg's Archives of Pharmacology

Study on the mechanism of hirudin multi target delaying renal function decline in chronic kidney disease based on the “gut-kidney axis” theory

Article

Author: Long, Chunli ; Xie, Yongxiang ; Zhang, Chenyun

AbstractThe disorder of the “gut-kidney axis” exacerbates renal function decline in chronic kidney disease (CKD), and current CKD therapy is insufficient to address this issue. Hirudin has a palliative effect on the decline of renal function. However, whether hirudin can delay CKD by regulating the “intestinal renal axis” disorder remains unclear. Unilateral ureteral ligation (UUO) induced CKD rat model, and the rats were treated with bifidobacterium and hirudin for 36 days. After 14 and 36 days of modeling, kidney and colon tissues were collected for pathology, western blot (WB) assay, and quantitative real-time PCR (qPCR) detection. Serum samples were collected for renal function testing. Fecal samples were used for 16S rRNA sequencing and research on fecal bacterial transplantation. Lipopolysaccharide combine with adenosine 5’-triphosphate (LPS + ATP)-induced intestinal epithelial cell injury was treated with a nod-like receptor pyrin domain-associated protein 3 (NLRP3) inhibitor and hirudin. Protein expression was detected using WB and qPCR. The kidneys and colons of the CKD rats exhibited varying degrees of lesions. Creatinine (CRE), blood urea nitrogen (BUN), N-acetyl-β-D-glucosidase (NAG) enzyme, and serum uremic toxins were elevated. The expression of claudin-1 and occludin was decreased, NLRP3 inflammatory-related proteins were increased, and the gut microbiota was disrupted. These pathological changes were more pronounced after 36 days of modeling. Meanwhile, high-dose hirudin treatment significantly improved these lesions and restored the intestinal flora to homeostasis in CKD rats. In vitro, hirudin demonstrated comparable effects to NLRP3 inhibitors by upregulating claudin-1 and occludin expression, and downregulating NLRP3 inflammatory-related proteins expression. The dysbiosis of the gut microbiota and impaired intestinal epithelial barrier function in CKD are associated with renal dysfunction in CKD. Hirudin delays the progression of CKD by regulating the disorder of the “gut-kidney axis” and inhibiting the activation of the NLRP3-ASC-caspase-1 pathway.

100 Deals associated with Hirudin biosimilar(Rhein-Minapharm)

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Indication	Country/Location	Organization	Date
Venous Thrombosis	EG	Rhein-Minapharm	01 Oct 2006

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