Delving into the Latest Updates on Batroxobin(Tobishi Pharm) with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Target

Fibrinogen

Mechanism

Fibrinogen inhibitors

Therapeutic Areas

Cardiovascular DiseasesNervous System DiseasesOtorhinolaryngologic Diseases

Active Indication

Arteriosclerosis ObliteransHearing Loss, Sudden

Inactive Indication-

Originator Organization

Tobishi Pharmaceutical Co. Ltd.

Active Organization

Dongying Tiandong Pharmaceutical Co. Ltd.Tobishi Pharmaceutical Co. Ltd.

Simcere Pharmaceutical (Hainan) Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (28 Jun 1989),

Arteriosclerosis Obliterans

Regulation-

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主要目的：比较中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的药代动力学特征及生物等效性评价。次要目的：（1）评价中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的药效学特征；（2）评价中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的安全性和耐受性。

[Translation]

Primary objective: To compare the pharmacokinetic characteristics and bioequivalence evaluation of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion. Secondary objectives: (1) To evaluate the pharmacodynamic characteristics of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion; (2) To evaluate the safety and tolerability of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion.

Start Date17 Jun 2024

Sponsor / Collaborator

Simcere Pharmaceutical (Hainan) Co. Ltd.

[+1]

JPRN-jRCTs031180059 / CompletedNot ApplicableIIT

Exploratory clinical study of DF-521 in Amyotrophic Lateral Sclerosis(2) - ECSDA2

Start Date16 Oct 2017

Sponsor / Collaborator

Tobishi Pharmaceutical Co. Ltd.

JPRN-jRCTs031180058 / CompletedNot ApplicableIIT

Exploratory clinical study of DF-521 in Amyotrophic Lateral Sclerosis (3) - ECSDA3

Start Date28 Sep 2017

Sponsor / Collaborator

Tobishi Pharmaceutical Co. Ltd.

100 Clinical Results associated with Batroxobin(Tobishi Pharm)

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100 Translational Medicine associated with Batroxobin(Tobishi Pharm)

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100 Patents (Medical) associated with Batroxobin(Tobishi Pharm)

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6

Literatures (Medical) associated with Batroxobin(Tobishi Pharm)

01 Oct 2007·Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery

[Prognosis and treatment of sudden sensorineural hearing loss with total and severe all frequency hearing loss].

Article

Author: Xia, Rui-ming ; Yu, Li-sheng ; Li, Hua-ting

OBJECTIVETo evaluate the treatment and prognosis of sudden sensorineural hearing loss (SSHL) with total and severe all frequency hearing loss.METHODSSixty-two patients diagnosed as SSHL (0.25, 0.5, 1, 2, 4 kHz pure tone average > or = 56 dB) were studied from January 2003 to October 2006, in which 18 of them were treated with Xueshuantong (Panax notoginseng saponins) while 19 of them treated with steroid and Xueshuantong, and 25 of them treated with steroid, DF-521 and Xueshuantong.RESULTSThe hearing improvement rate of the patients treated with Xueshuantong was 22.2% (4/18) while the patients treated with steroid and Xueshuantong was 57.9% (11/19) and the patients treated with steroid, DF-521 and Xueshuantong was 68.0% (17/25). The good improvement rate of the patients treated with Xueshuantong was 5.6% (1/18) while the patients treated with steroid and Xueshuantong was 36.8% (7/19) and the patients treated with steroid, DF-521 and Xueshuantong was 60.0% (15/25). Over hearing improvement was significantly better in patients treated with steroid, defibrinogenation and Xueshuantong than in those treated with Xueshuantong only (P < 0.05). The patients of total hearing loss had a significantly higher vertigo rate and worse therapy effect.CONCLUSIONSThe combined therapy include high-dose corticosteroids and defibrinogenation therapy is effective for the patients with total deafness and severe all frequency hearing loss. The prognosis of patients with total hearing loss was poor.

01 Jan 2005·Intracranial Pressure and Brain Monitoring XII

Effects of venom defibrase on brain edema after intracerebral hemorrhage in rats

Article

Author: F. P. Huang ; G. Wu

We evaluated the effects of defibrase DF-521 batroxobin on reducing brain edema formation and the expression of ICAM-1, complement C3d and C9 in the perihematomal area after intracerebral hemorrhage (ICH) in rats. A rat ICH model, involving infusion of autologous blood into the right basal ganglia, were used in this study. The animals were sacrificed at 24 and 72 hours after ICH to determine the water content of the brain tissue with wet/dry weight measurement. While the expression of ICAM-1 and complement C3d was detected using immuno-histochemistry, and C9 was detected semi-quantitatively with Western blot analysis in the perihematomal area. Perihematomal brain edema was reduced after intraperitoneally injection of DF-521 batroxobin 24 and 72 hours after intracerebral hemorrhage. Immunohistochemistry showed that there were less ICAM-I positive cells were found around the hematoma after intraperitoneally injection of DF-521 batroxobin 24 and 72 hours after ICH. Immuno-histochemistry also showed that C3d deposition reduced significantly, and the Western blot analysis also showed the content of C9 protein declined around the hematoma in DF-521 batroxobin treatment group at 72 hours after ICH. Defibrase DF-521 batroxobin down-regulate ICAM-1 and complement C3d and C9 expression in the perihematomal area, and attenuate brain edema formation in ICH rats.

01 May 2004·Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition

[Effectiveness of urokinase used in combination with batroxobin (DF-521) in rat model of focal cerebral ischemia-reperfusion].

Article

Author: Huang, Juan ; Hu, Xiang-shu ; Hu, Xiang-yu ; Zhang, Yin-zhu ; Zhou, Dong ; Tian, Lin-yu

OBJECTIVEThis study was designed to use urokinase (UK) in combination with batroxobin in thrombolytic therapy so as to see whether batroxobin(DF-521) would be effective for neuroprotection.METHODSThe model of right middle cerebral artery occlusion (MCAO) in male SD rats was established. 120 rats were randomized into 9 groups, namely control group, sham control group, and groups that were treated with batroxobin and urokinase together or separately. Each group comprised 15 rats. Intracranial bleeding, infarct volume ratio and neurological function were observed.RESULTSIntracranial bleeding was found in 5 rats of the UK 5000 U/kg group, in 4 rats of the UK 5000 U/kg (2 h) + DF-521 5 BU/kg (2 h) group, and in only 1 rat of the UK 5000 U/kg (2 h) + DF-521 5 BU/kg (1 h) group. Cerebral infarct volume ratio was obviously reduced in 5 BU/kg batroxobin group. No difference was observed in neurological deficit scores.CONCLUSION5000 U/kg urokinase increased the risk of intracranial hemorrhage in rat MCAO model. Batroxobin either used separately or in combination with urokinase would not increase the risk of intracranial hemorrhage in rat MCAO model.

100 Deals associated with Batroxobin(Tobishi Pharm)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arteriosclerosis Obliterans	JP	Tobishi Pharmaceutical Co. Ltd.	28 Jun 1989

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss, Sudden	Phase 1	CN	Dongying Tiandong Pharmaceutical Co. Ltd.	17 Jun 2024
Hearing Loss, Sudden	Phase 1	CN	Simcere Pharmaceutical (Hainan) Co. Ltd.	17 Jun 2024