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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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 |
Indications
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Agency Specific
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ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AE: Direct thrombin inhibitors
— B02: Antihemorrhagics
— B02B: Vitamin k and other hemostatics
— B02BC: Local hemostatics
— B02BC06: Thrombin
— B02BD: Blood coagulation factors
— B02BD30: Thrombin
Clinical
Clinical Trials
553 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 | 4 | 7 | 23 | 16 | 38 | 87 |
| Thrombosis | D013927 | — | — | 3 | 8 | 9 | 5 | 38 | 60 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | 2 | 5 | 3 | 35 | 44 |
| Hemostatic disorders | D020141 | — | — | — | 2 | 5 | 3 | 35 | 44 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 7 | 6 | 1 | 14 | 27 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | 1 | 3 | 2 | 17 | 23 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | 1 | 16 | 18 |
| Thromboembolism | D013923 | — | — | — | 3 | 2 | 3 | 10 | 17 |
| Surgical blood loss | D016063 | — | — | — | 1 | 4 | 4 | 7 | 16 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 4 | 5 | 3 | 4 | 15 |
Show 78 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | — | I82.40 | — | 6 | 7 | — | 14 | 24 |
| Embolism | D004617 | — | — | — | 1 | 3 | — | 12 | 15 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 2 | — | 9 | 11 |
| Ulcer | D014456 | MPATH_579 | — | 3 | 2 | 3 | — | 3 | 10 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 3 | 3 | — | 2 | 8 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 2 | 2 | — | 4 | 7 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 2 | — | 3 | 5 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | 1 | — | 2 | 4 |
| Liver failure | D017093 | — | K72.9 | — | — | 2 | — | 2 | 4 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | 2 | — | 1 | 4 |
Show 34 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 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | 2 | 3 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | 2 | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 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 | — | Q24.9 | — | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | 1 | 2 |
| Pathologic processes | D010335 | — | — | — | 1 | — | — | — | 1 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | 4 | 5 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | 1 | — | — | — | 2 | 3 |
| Virus diseases | D014777 | — | B34 | 1 | — | — | — | 1 | 2 |
| Corneal injuries | D065306 | — | — | 2 | — | — | — | — | 2 |
| Intraabdominal infections | D059413 | — | — | 1 | — | — | — | — | 1 |
| Intestinal fistula | D007412 | — | K63.2 | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 11 | 11 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 8 | 8 |
| Thrombophilia | D019851 | — | D68.59 | — | — | — | — | 6 | 6 |
| Disseminated intravascular coagulation | D004211 | — | D65 | — | — | — | — | 6 | 6 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 5 | 5 |
| Coagulation protein disorders | D020147 | — | — | — | — | — | — | 5 | 5 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 5 | 5 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 4 | 4 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | — | — | 4 | 4 |
| Hepatitis | D006505 | — | K75.9 | — | — | — | — | 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.
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| 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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Safety
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3,307 adverse events reported
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