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TH

thrombin (ThrombiRAAS)

✓ Approved

Shanghai RAAS Blood Products Co., Ltd. · F2 · Cell-based Therapies

What is thrombin?

thrombin is a cell-based therapies developed by Shanghai RAAS Blood Products Co., Ltd.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesThrombiRAAS
CompanyShanghai RAAS Blood Products Co., Ltd.
Drug ClassCell-based Therapies
Molecular TargetF2
RouteOral (PO)
StatusApproved

Mechanism of Action

Molecular Targets

thrombin acts on 1 molecular target:

F2coagulation factor II, thrombin (THPH1, PT)
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Therapeutic Indications

thrombin is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Vascular disordersExtravasation blood✓ Approved
Vascular disordersHaemorrhage✓ Approved

Related Research Articles

PubMedJournal of chemical information and modeling2026-05-24

Molecular Modeling of Protein-Peptide Complexes Mimicking Factor Xa-Prothrombin Using AlphaFold-Multimer and Molecular Dynamics Simulations for Functional Prediction.

Veizaj Dejvid D, Poole David A DA, Cheung Ka Lei KL, Flier Jos V JV et al.

Accurately predicting how point mutations influence protease activity is a major challenge in protein engineering and in the study of coagulation disorders. Factor Xa (FXa) catalyzes the proteolytic activation of prothrombin, a critical step in thrombin generation, yet the molecular details of direct enzyme-substrate recognition and the impact of pathogenic variants remain incompletely defined. Here, we combined AlphaFold-Multimer modeling with explicit-solvent molecular dynamics (MD) simulations to investigate simplified FXa-substrate interactions using prothrombin-derived peptides encompassing the Arg271 and Arg320 cleavage sites in the absence of the full prothrombinase complex. AlphaFold predictions identified catalytically competent peptide orientations, while subsequent MD simulations and free energy analyses identified key contributions of the P1 and P4 cleavage site residues to FXa binding. Distinct stability and affinity differences between the two cleavage sites were highlighted. Active site variants associated with factor X deficiency demonstrated variant-specific disruptions in peptide engagement, implicating key residues within the FXa active site as critical determinants of catalytic activity. Experimental validation with recombinant FXa variants was consistent with the computational predictions, indicating comparable inhibition by the prothrombin peptides. Together, these findings establish an integrative computational-experimental framework for probing local protease-substrate recognition, rationalizing the effects of disease-causing mutations, and guiding the design of therapeutic protease variants.

PubMedJournal of the American Society of Cytopathology2026-05-23

Enhanced cellularity in plasma-thrombin cell block preparations: an improved method.

Hellrung Joseph J, Kucher Erek E, Vande Berg Mariah M, Selvaggi Suzanne M SM

Cell blocks are cytologic preparations that enable histologic evaluation and ancillary testing but are often limited by low cellularity. The plasma-thrombin method is widely used but can yield suboptimal cellular material. We validated an improved plasma-thrombin method incorporating a second centrifugation step (1712 rpm, 10 min) after plasma and thrombin addition and the use of phloxine dye to enhance pellet visualization. Twenty paired body fluid samples were processed using standard and improved methods. Cellularity was quantified using digital image-based cell counting in the most cellular 20× field with the OnCellCounter platform; complete data were available for 18 paired cases and compared using the Wilcoxon signed-rank test. Following validation, the method was implemented hospital-wide. Adequacy (≥10 mesothelial cells, diagnostic atypia, or significant inflammation) was compared over 3-month periods before (June-August 2024) and after (April-June 2025) implementation using a Pearson χ2 test. In the validation cohort, the improved method showed higher cell counts in 12/18 (66.7%) cases, unchanged in 1/18 (5.6%), and lower in 5/18 (27.8%). Median cell count increased from 178 to 292 cells per 20× field (Wilcoxon P = 0.039), with complete diagnostic concordance. After implementation, adequacy improved from 56.5% (182/322) to 80.1% (277/346), an absolute increase of 23.5% (χ2 = 42.98, P < 0.001). Simple modifications to the plasma-thrombin method significantly improve cellularity and adequacy. This low-cost approach enhances diagnostic yield and may reduce repeat procedures.

PubMedJBJS case connector2026-05-22

Lateral Circumflex Femoral Artery Pseudoaneurysm Post-Hip Arthroscopy and Periacetabular Osteotomy in Ehlers-Danlos Syndrome: A Case Report.

Bosakhar Batool B, Balakumar Jitendra J

An 18-year-old woman with Ehlers-Danlos syndrome developed subacute thigh pain on postoperative day 21 following elective hip arthroscopy and a periacetabular osteotomy. Doppler ultrasound revealed a pulsatile "yin-yang" lesion in the rectus femoris, and CT angiography confirmed a pseudoaneurysm of the lateral circumflex femoral artery with an arteriovenous fistula. Endovascular coil embolization with thrombin injection achieved complete thrombosis and symptom resolution. Vascular injury, though rare, should be considered after hip arthroscopy in patients with connective tissue disorders. Early multimodal imaging enables timely diagnosis, and minimally invasive endovascular treatment can provide definitive management with low morbidity.

PubMedTH open : companion journal to thrombosis and haemostasis2026-05-22

In Vitro Study of the Role of Factor IX in Treatment of Breakthrough Bleeds in Patients with Hemophilia A and Inhibitors Receiving Emicizumab.

Janbain Maissaa M, Josset Laurie L, Leuci Alexandre A, Zakharia Karam K et al.

Hemophilia A (HA) is an X-linked disorder characterized by a deficiency of factor VIII (FVIII). Approximately 30% of patients with severe HA (baseline FVIII levels < 1 IU/dL) develop antibodies that neutralize the activity of FVIIIs. Emicizumab, a bispecific monoclonal antibody that has FVIII mimetic activity, is effective at preventing bleeding in patients with HA and has become a standard prophylactic therapy for hemophilia patients with inhibitors. However, breakthrough bleeding and perioperative management still require additional bypassing agents, which increases the risk of thrombosis in these patients. This in vitro study compares the hemostatic effect of adding factor IX (FIX) to the plasma of HA patients on emicizumab prophylaxis with the addition of bypassing agents. Blood from 24 HA patients on emicizumab was collected, and plasma samples were spiked with increasing concentrations of recombinant factor VIIa (rFVIIa), activated prothrombin complex concentrate (aPCC), recombinant FIX (rFIX), and plasma-derived FIX (pdFIX). Thrombin generation (TG) was assessed using calibrated automated thrombography. Plasma emicizumab and FIX activity were measured. TG capacity improved significantly with increasing concentrations of rFVIIa ( p  < 0.0001), aPCC, rFIX, and pdFIX ( p  < 0.005). In contrast to high doses of aPCC and rFVIIa, TG parameters obtained with the addition of FIX did not cross the upper limit of normal physiologic ranges. Our data suggest a possible increased risk of thrombosis with higher concentrations of rFVIIa and aPCC, while adjunctive FIX therapy appears to be safe and effective in improving coagulation in HA patients with inhibitors on emicizumab prophylaxis. Future clinical trials are needed to confirm these results.

PubMedJournal of ethnopharmacology2026-05-21

Screening of antithrombotic components from Typhae Pollen by a multidimensional evaluation strategy.

Kuang Yu-Jia YJ, Weng Ze-Bin ZB, Chen Qian-Qian QQ, Zhu Bo-Zhen BZ et al.

Typhae Pollen (TP) has long been used in traditional Chinese medicine to promote blood circulation and resolve blood stasis, particularly in the management of thrombotic disorders. However, its bioactive constituents and antithrombotic mechanisms remain incompletely understood. This study aimed to systematically characterize the chemical constituents of TP and to elucidate its antithrombotic activity and underlying mechanisms. Comprehensive phytochemical profiling of TP was performed using UHPLC-QTOF-MS/MS combined with diagnostic fragment ion (DFI) and neutral loss (NL) filtering strategies. Multivariate statistical analysis was applied to evaluate chemical consistency and regional variation among TP samples. Antithrombotic activity was assessed using thrombin inhibition assays, ADP-induced platelet aggregation assays, and zebrafish thrombosis models. Molecular docking was conducted to analyze interactions between active constituents and thrombin. The effects of TP-derived compounds on inflammatory cytokines, apoptosis-related proteins, and adhesion molecules were further investigated. UHPLC-QTOF-MS/MS analysis identified 70 compounds, including flavonoids, organic acids, and other compound classes in TP, with overall chemical consistency despite regional differences. TP extract exhibited significant thrombin inhibitory activity, with seven organic acids showing notable effects (IC50 = 0.209-0.457 mg/mL), and molecular docking revealed favorable binding affinities with thrombin (-5.20 to -6.17 kcal/mol). TP extract, p-coumaric acid, succinic acid, and citric acid significantly inhibited ADP-induced platelet aggregation in vitro. In zebrafish models, specific organic acids (catechin and p-coumaric acid), and flavonoids (rutin and hyperoside) markedly reduced arachidonic acid-induced cardiac red blood cell accumulation. Network pharmacology analysis suggested that the antithrombotic effects of TP-derived compounds may be associated with multiple targets and pathways related to inflammation, oxidative stress, endothelial function, and vascular responses, including HIF-1, AGE-RAGE, and PI3K-Akt signaling pathways. These findings demonstrate that flavonoids and organic acids are the major antithrombotic constituents of TP, providing a scientific basis for its traditional use in treating blood stasis and thrombotic disorders.

PubMedBlood advances2026-05-21

Bone Mineral Density, Bone Remodeling Biomarkers, and Hemostatic Correlates in Hemophilia and von Willebrand Disease.

Citla-Sridhar Divyaswathi D, Chung Simon S, Brown Andrew W AW, Crary Shelley E SE et al.

Persons with hemophilia (PwH) have lower bone mineral density (BMD) and increased fracture risk, but data for persons with von Willebrand disease (PwVWD) are limited. Biological mechanisms underlying altered bone health in bleeding disorders remain poorly defined. Primary aim: compare total BMD among PwH, PwVWD, and healthy controls. Secondary aim: characterize bone remodeling biomarkers and examine associations between BMD and simultaneous thrombin-plasmin generation (STP). In a three-group, cross-sectional observational study of participants aged 5-45 years (34 PwH, 45 PwVWD, 30 controls), total BMD and bone mineral content (BMC) were assessed by dual-energy X-ray absorptiometry ; trabecular and cortical parameters were assessed by peripheral quantitative computed tomography ; serum procollagen type 1 N-terminal propeptide and C-terminal telopeptide of type I collagen were measured as markers of bone formation and resorption; and STP assays quantified coagulation and fibrinolytic activity. Associations with BMD Z-scores were evaluated using linear and multivariable regression. PwVWD had significantly lower BMD Z-scores compared with controls, while PwH showed a similar but nonsignificant trend. Both PwH and PwVWD had significantly lower BMC. In multivariable models, higher thrombin generation was associated with higher BMD Z-scores, whereas higher plasmin generation was associated with lower BMD Z-scores. In multivariable models, STP parameters were associated with BMD and accounted for a greater proportion of variance than models including clinical factors or bone turnover markers. PwH and PwVWD exhibit measurable deficits in bone health. Observed associations between thrombin-plasmin dynamics and BMD are hypothesis-generating and support further longitudinal and mechanistic studies of hemostasis-bone relationships.

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