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 | 2024-06-20 |
| thrombin human | Biologic Licensing Application | 2009-09-13 |
| thrombin-jmi | Biologic Licensing Application | 2011-06-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| surgical hemostasis | — | D006488 | — |
| hemostasis | — | D006487 | — |
Agency Specific
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Clinical
Clinical Trials
742 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 | 5 | 8 | 26 | 20 | 40 | 98 |
| Thrombosis | D013927 | — | — | 3 | 8 | 9 | 5 | 38 | 60 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | 2 | 5 | 3 | 34 | 43 |
| Hemostatic disorders | D020141 | — | — | — | 2 | 5 | 3 | 34 | 43 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 7 | 6 | 1 | 14 | 27 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | 1 | 3 | 2 | 17 | 23 |
| Wounds and injuries | D014947 | — | T14.8 | 3 | 5 | 6 | 1 | 9 | 20 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | 1 | 16 | 18 |
| Surgical blood loss | D016063 | — | — | — | 2 | 5 | 4 | 7 | 17 |
| Thromboembolism | D013923 | HP_0001907 | — | — | 3 | 2 | 3 | 10 | 17 |
Show 106 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | 6 | 7 | — | 14 | 24 |
| Pterygium | D011625 | — | H11.0 | 2 | 1 | 3 | — | 11 | 16 |
| Embolism | D004617 | — | — | — | 1 | 3 | — | 12 | 15 |
| Ulcer | D014456 | MPATH_579 | — | 5 | 3 | 4 | — | 3 | 14 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | — | 2 | — | 9 | 11 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 3 | 3 | — | 2 | 8 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 2 | 2 | — | 4 | 7 |
| Tympanic membrane perforation | D018058 | — | H72 | 1 | 3 | 2 | — | 2 | 7 |
| Rectal fistula | D012003 | HP_0010447 | K60.3 | — | — | 3 | — | 3 | 6 |
| Cerebrospinal fluid leak | D065634 | — | G96.0 | — | 1 | 4 | — | 1 | 6 |
Show 66 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | — | 2 | — | — | 4 | 6 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 2 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | 2 | 3 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | 2 | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | 2 | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | — | 2 |
| Transfusion reaction | D065227 | — | D69.51 | — | 1 | — | — | 1 | 2 |
| Blood transfusion | D001803 | — | — | — | 1 | — | — | 1 | 2 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 1 | — | — | 1 | 2 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | 2 | 1 | — | — | — | 2 |
Show 39 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | 1 | — | — | — | 2 | 3 |
| Rupture | D012421 | — | — | 2 | — | — | — | 1 | 3 |
| Corneal injuries | D065306 | HP_0000559 | — | 3 | — | — | — | — | 3 |
| Corneal ulcer | D003320 | — | H16.0 | 1 | — | — | — | 1 | 2 |
| Virus diseases | D014777 | — | B34 | 1 | — | — | — | 1 | 2 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | 1 | — | — | — | 1 | 2 |
| Intraabdominal infections | D059413 | — | — | 1 | — | — | — | — | 1 |
| Intestinal fistula | D007412 | — | K63.2 | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | — | — | — | — | 11 | 11 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 8 | 8 |
| Thrombophilia | D019851 | — | D68.59 | — | — | — | — | 6 | 6 |
| Recurrence | D012008 | — | — | — | — | — | — | 6 | 6 |
| Disseminated intravascular coagulation | D004211 | HP_0005521 | D65 | — | — | — | — | 6 | 6 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 5 | 5 |
| Coagulation protein disorders | D020147 | — | — | — | — | — | — | 5 | 5 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 4 | 4 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | — | 4 | 4 |
| Toxemia | D014115 | — | — | — | — | — | — | 4 | 4 |
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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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Trends
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Safety
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Adverse Events
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3,185 adverse events reported
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