Overview
Batroxobin is a defibrinogenating hemostatic agent derived from the venom of a pit viper, Bothrops atrox moojeni. In addition to batroxobin, the venom of Bothrops atrox has a composition of 10.2% neutral carbohydrate. Batroxobin is a serine protease, which cleaves the 16 Arginine - 17 Glycine bond in fibrinogen. The MW of batroxobin is approximately 43,000 g/mol-1, and it contains 231 amino acids. Batroxobin is inactivated by alpha2-macroglobulin, but not anti-thrombin compounds. Batroxobin will also bind fibrinogen in a manner different than thrombin and with a higher affinity. Once bound to fibrin, it will cause fibrin accretion(clot formation) to a degree 18 folds greater than thrombin. Currently use is experimental but trials have been conducted which support certain clinical applications. Recombinant Batroxobin in relatively affordable and could be accessed by mass production.
Background
Batroxobin is a defibrinogenating hemostatic agent derived from the venom of a pit viper, Bothrops atrox moojeni. In addition to batroxobin, the venom of Bothrops atrox has a composition of 10.2% neutral carbohydrate. Batroxobin is a serine protease, which cleaves the 16 Arginine - 17 Glycine bond in fibrinogen. The MW of batroxobin is approximately 43,000 g/mol-1, and it contains 231 amino acids. Batroxobin is inactivated by alpha2-macroglobulin, but not anti-thrombin compounds. Batroxobin will also bind fibrinogen in a manner different than thrombin and with a higher affinity. Once bound to fibrin, it will cause fibrin accretion(clot formation) to a degree 18 folds greater than thrombin. Currently use is experimental but trials have been conducted which support certain clinical applications. Recombinant Batroxobin in relatively affordable and could be accessed by mass production.
Indication
No approved indications. Batroxobin is a defibrongenating agent which has been observed to reduce fibrinogen levels and thus reduce clot risk when used intravenously.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/17 | Phase 4 | UNKNOWN | Capital Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Batroxobin Injection | 国药准字H20030295 | 化学药品 | 注射剂(小容量注射剂) | 9/4/2020 | |
| Batroxobin Injection | 国药准字H20031074 | 化学药品 | 注射剂（小容量注射剂） | 6/30/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||