Thrombin
Evicel, TachoSil, VeraSeal (thrombin) is an unknown pharmaceutical. Thrombin was first approved as Tachosil on 2004-06-08. It is used to treat hemorrhage in the USA. It has been approved in Europe to treat hemostasis and surgical hemostasis.
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Commercial
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FDA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| recothrom | Biologic Licensing Application | 2024-01-04 |
| tachosil | Biologic Licensing Application | 2025-02-11 |
| thrombin human | Biologic Licensing Application | 2009-09-13 |
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Clinical
Clinical Trials
95 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 5 | 9 | 5 | 6 | 25 |
| Surgical blood loss | D016063 | — | — | — | 1 | 2 | 1 | 3 | 7 |
| Hemostasis | D006487 | — | — | 1 | 3 | — | 1 | 2 | 6 |
| Healthy volunteers/patients | — | — | — | 4 | 1 | — | 1 | — | 5 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 2 | 1 | 1 | — | 4 |
| Soft tissue injuries | D017695 | — | — | — | — | 3 | 1 | — | 4 |
| Thrombosis | D013927 | — | — | — | — | — | 1 | 2 | 3 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | 1 | 2 |
| Cardiovascular surgical procedures | D013504 | — | — | — | — | — | 2 | — | 2 |
| Rotator cuff injuries | D000070636 | — | M75.1 | 1 | — | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | — | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 1 | — | 1 | 3 |
| Surgical hemostasis | D006488 | — | — | — | 1 | 2 | — | — | 3 |
| Cerebrospinal fluid leak | D065634 | — | G96.0 | — | — | 2 | — | — | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | 1 | — | — | 1 |
| Varicose veins | D014648 | — | I83.90 | — | — | 1 | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Intraoperative complications | D007431 | — | — | — | — | 1 | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | — | 2 |
| Transfusion reaction | D065227 | — | D69.51 | — | 1 | — | — | 1 | 2 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 1 | — | — | 1 | 2 |
| Islets of langerhans transplantation | D016381 | — | — | — | 1 | — | — | — | 1 |
| Epidermolysis bullosa | D004820 | — | Q81 | — | 1 | — | — | — | 1 |
| Epidermolysis bullosa dystrophica | D016108 | — | Q81.2 | — | 1 | — | — | — | 1 |
| Hemorrhagic shock | D012771 | — | — | — | 1 | — | — | — | 1 |
| Blood transfusion | D001803 | — | — | — | 1 | — | — | — | 1 |
| Postoperative complications | D011183 | — | — | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Virus diseases | D014777 | — | B34 | 1 | — | — | — | 1 | 2 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | 1 | — | — | — | — | 1 |
| Marburg virus disease | D008379 | EFO_0007358 | A98.3 | 1 | — | — | — | — | 1 |
| Muscular atrophy | D009133 | — | — | 1 | — | — | — | — | 1 |
| Rupture | D012421 | — | — | 1 | — | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 5 | 5 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 5 | 5 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 2 | 2 |
| Disseminated intravascular coagulation | D004211 | — | D65 | — | — | — | — | 2 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Adenoma | D000236 | — | — | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | — | 1 | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Thrombin |
| INN | thrombin |
| Description | Thrombin (EC 3.4.21.5, fibrinogenase, thrombase, thrombofort, topical, thrombin-C, tropostasin, activated blood-coagulation factor II, blood-coagulation factor IIa, factor IIa, E thrombin, beta-thrombin, gamma-thrombin) is a serine protease, an enzyme that, in humans, is encoded by the F2 gene.
|
| Classification | Unknown |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >4UD9:H|Thrombin heavy chain
IVEGSDAEIGMSPWQVMLFRKSPQELLCGASLISDRWVLTAAHCLLYPPWDKNFTENDLLVRIGKHSRTRYERNIEKISM
LEKIYIHPRYNWRENLDRDIALMKLKKPVAFSDYIHPVCLPDRETAASLLQAGYKGRVTGWGNLKETWTANVGKGQPSVL
QVVNLPIVERPVCKDSTRIRITDNMFCAGYKPDEGKRGDACEGDSGGPFVMKSPFNNRWYQMGIVSWGEGCDRDGKYGFY
THVFRLKKWIQKVIDQFGE
>4UD9:I|Hirudin-2
GDFEEIPEE(TYS)LQ
>4UD9:L|Prothrombin
EADCGLRPLFEKKSLEDKTERELLESYI |
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225 adverse events reported
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