Thrombin - PharmaKB

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

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
signs and symptoms pathological conditions	D013568
therapeutics	D013812
operative surgical procedures	D013514
circulatory and respiratory physiological phenomena	D002943

Trade Name

FDA

EMA

Evithrom, Recothrom, Thrombin-jmi, thrombocoll (discontinued: Evithrom)

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Thrombin

topical (bovine)

Tradename	Proper name	Company	Number	Date	Products
Thrombin-Jmi, Thrombocoll	Thrombin, Topical (Bovine)	GenTrac	A-102865 RX	1986-02-03	2 products

Thrombin

topical (human)

Tradename	Proper name	Company	Number	Date	Products
Evithrom	Thrombin, Topical (Human)	Omrix Biopharmaceuticals	A-125247 RX	2009-09-17	1 products

Show 1 discontinued

Thrombin topical (recombinant)

Tradename	Proper name	Company	Number	Date	Products
Recothrom	Thrombin topical (Recombinant)	Baxter	A-125248 RX	2008-01-17	2 products

Labels

FDA

EMA

Brand Name	Status	Last Update
recothrom	Biologic Licensing Application	2025-06-09
tachosil	Biologic Licensing Application	2025-08-29
thrombin human	Biologic Licensing Application	2009-09-13
thrombin-jmi	Biologic Licensing Application	2011-06-17

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hemorrhage	MP_0001914	D006470	R58

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

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

HCPCS

Code	Description
J7168	Prothrombin complex concentrate (human), kcentra, per i.u. of factor ix activity
J7196	Injection, antithrombin recombinant, 50 i.u.
J7197	Antithrombin iii (human), per i.u.

Clinical

Clinical Trials

576 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	3	7	20	16	37	82
Thrombosis	D013927	—	—	3	8	8	5	40	61
Blood coagulation disorders	D001778	EFO_0009314	D68.9	—	2	6	2	35	44
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	4	2	18	25
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	1	—	1	16	18
Stroke	D020521	EFO_0000712	I63.9	2	5	5	3	5	17
Thromboembolism	D013923	—	—	—	3	2	3	10	17
Surgical blood loss	D016063	—	—	—	1	4	4	7	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Venous thrombosis	D020246	—	I82.40	—	6	6	—	14	23
Embolism	D004617	—	—	—	1	2	—	12	14
Pulmonary embolism	D011655	EFO_0003827	I26	—	—	2	—	9	11
Ulcer	D014456	MPATH_579	—	2	1	4	—	3	10
Myocardial ischemia	D017202	EFO_1001375	I20-I25	—	2	2	—	5	8
Heart diseases	D006331	EFO_0003777	I51.9	—	3	3	—	2	8
Coagulation protein disorders	D020147	—	—	—	—	1	—	5	6
Vascular diseases	D014652	EFO_0004264	I77	—	1	1	—	4	6
Heart failure	D006333	EFO_0003144	I50	—	1	2	—	3	5
Breast neoplasms	D001943	EFO_0003869	C50	—	—	1	—	3	4

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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
Congenital heart defects	D006330	—	Q24.9	—	1	—	—	2	3
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	1	—	—	2	3
Plasma cell neoplasms	D054219	—	—	—	1	—	—	1	2
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
Kidney diseases	D007674	EFO_0003086	N08	—	1	—	—	1	2
Arterial occlusive diseases	D001157	EFO_0009085	—	—	1	—	—	1	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Covid-19	D000086382	—	U07.1	1	—	—	—	11	12
Neoplasms	D009369	—	C80	1	—	—	—	5	6
Interstitial lung diseases	D017563	EFO_0004244	J84.9	1	—	—	—	2	3
Intestinal fistula	D007412	—	K63.2	1	—	—	—	1	2
Cognitive dysfunction	D060825	—	G31.84	1	—	—	—	1	2
Virus diseases	D014777	—	B34	1	—	—	—	1	2
Corneal injuries	D065306	—	—	2	—	—	—	—	2
Intraabdominal infections	D059413	—	—	1	—	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	1	—	—	—	—	1
Systemic scleroderma	D012595	EFO_0000717	M34	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sepsis	D018805	EFO_0001420	A41.9	—	—	—	—	10	10
Thrombophilia	D019851	—	D68.59	—	—	—	—	7	7
Disseminated intravascular coagulation	D004211	—	D65	—	—	—	—	6	6
Carcinoma	D002277	—	C80.0	—	—	—	—	6	6
Sickle cell anemia	D000755	EFO_0000697	D57	—	—	—	—	5	5
Toxemia	D014115	—	—	—	—	—	—	5	5
Hepatocellular carcinoma	D006528	—	C22.0	—	—	—	—	5	5
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	4	4
Blood coagulation	D001777	GO_0007596	—	—	—	—	—	3	3
Recurrence	D012008	—	—	—	—	—	—	3	3

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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

Identifiers

PDB	148D, 1A0H, 1A2C, 1A3B, 1A3E, 1A46, 1A4W, 1A5G, 1A61, 1ABI, 1ABJ, 1AD8, 1AE8, 1AFE, 1AHT, 1AI8, 1AIX, 1AVG, 1AWF, 1AWH, 1AY6, 1B5G, 1B7X, 1BA8, 1BB0, 1BBR, 1BCU, 1BHX, 1BMM, 1BMN, 1BTH, 1C1U, 1C1V, 1C1W, 1C4U, 1C4V, 1C4Y, 1C5L, 1C5N, 1C5O, 1CA8, 1D3D, 1D3P, 1D3Q, 1D3T, 1D4P, 1D6W, 1D9I, 1DE7, 1DIT, 1DLK, 1DM4, 1DOJ, 1DWB, 1DWC, 1DWD, 1DWE, 1DX5, 1E0F, 1EB1, 1EGT, 1EOJ, 1EOL, 1ETR, 1ETS, 1ETT, 1FPC, 1FPH, 1G30, 1G32, 1G37, 1GHV, 1GHW, 1GHX, 1GHY, 1GJ4, 1GJ5, 1H8D, 1H8I, 1HAG, 1HAH, 1HAI, 1HAO, 1HAP, 1HBT, 1HDT, 1HGT, 1HLT, 1HRT, 1HUT, 1HXE, 1HXF, 1ID5, 1IHS, 1IHT, 1JMO, 1JOU, 1JWT, 1K21, 1K22, 1KMA, 1KTS, 1KTT, 1KWM, 1LHC, 1LHD, 1LHE, 1LHF, 1LHG, 1MH0, 1MKW, 1MKX, 1MU6, 1MU8, 1MUE, 1NM6, 1NO9, 1NRN, 1NRO, 1NRP, 1NRQ, 1NRR, 1NRS, 1NT1, 1NU7, 1NU9, 1NY2, 1NZQ, 1O0D, 1O2G, 1OOK, 1OYT, 1P8V, 1PPB, 1PPC, 1PPH, 1QBV, 1QHR, 1QJ1, 1QJ6, 1QJ7, 1QUR, 1RD3, 1RDE, 1RIW, 1SB1, 1SFQ, 1SG8, 1SGI, 1SHH, 1SL3, 1T4U, 1T4V, 1TA2, 1TA6, 1TB6, 1TBQ, 1TBR, 1TBZ, 1THP, 1THR, 1THS, 1TMB, 1TMT, 1TMU, 1TOC, 1TOM, 1TQ0, 1TQ7, 1TWX, 1UCY, 1UMA, 1UVS, 1UVT, 1UVU, 1VIT, 1VR1, 1VZQ, 1W7G, 1WAY, 1WBG, 1XM1, 1XMN, 1YCP, 1YPE, 1YPG, 1YPJ, 1YPK, 1YPL, 1YPM, 1Z71, 1Z8I, 1Z8J, 1ZGI, 1ZGV, 1ZRB, 2A0Q, 2A1D, 2A2X, 2A45, 2AFQ, 2ANK, 2ANM, 2B5T, 2BDY, 2BVR, 2BVS, 2BVX, 2BXT, 2BXU, 2C8W, 2C8X, 2C8Y, 2C8Z, 2C90, 2C93, 2CF8, 2CF9, 2CN0, 2ERW, 2F3C, 2FEQ, 2FES, 2GDE, 2GP9, 2H9T, 2HGT, 2HNT, 2HPP, 2HPQ, 2HWL, 2IDN, 2JH0, 2JH5, 2JH6, 2OCV, 2OD3, 2ODY, 2PGB, 2PGQ, 2PKS, 2PUX, 2PV9, 2PW8, 2R2M, 2THF, 2UUF, 2UUJ, 2UUK, 2UWL, 2UWO, 2V3H, 2V3O, 2WV1, 2ZC9, 2ZDA, 2ZDV, 2ZF0, 2ZFF, 2ZFP, 2ZFQ, 2ZFR, 2ZG0, 2ZGB, 2ZGX, 2ZHE, 2ZHF, 2ZHQ, 2ZHW, 2ZI2, 2ZIQ, 2ZNK, 2ZO3, 2ZPK, 3A1M, 3B23, 3B9F, 3BEF, 3BEI, 3BF6, 3BIU, 3BIV, 3BV9, 3C1K, 3C27, 3D49, 3D4U, 3D66, 3D67, 3D68, 3DA9, 3DD2, 3DGV, 3DHK, 3DT0, 3DUX, 3EDX, 3EE0, 3EGK, 3EQ0, 3F68, 3GIC, 3GIS, 3HAT, 3HK3, 3HK6, 3HKI, 3HKJ, 3HTC, 3JZ1, 3JZ2, 3K65, 3LDX, 3LMS, 3LU9, 3OSL, 3P17, 3P6Z, 3P70, 3PMA, 3PMB, 3PMH, 3PO1, 3QDZ, 3QGN, 3QLP, 3QTO, 3QTV, 3QWC, 3QX5, 3R3G, 3RLW, 3RLY, 3RM0, 3RM2, 3RML, 3RMM, 3RMN, 3RMO, 3S69, 3S7H, 3S7K, 3SHA, 3SHC, 3SI3, 3SI4, 3SQE, 3SQH, 3SV2, 3T5F, 3TU7, 3U69, 3U8O, 3U8R, 3U8T, 3U98, 3U9A, 3UTU, 3UWJ, 3VW7, 3VXE, 3VXF, 4AX9, 4AYV, 4AYY, 4AZ2, 4BAH, 4BAK, 4BAM, 4BAN, 4BAO, 4BAQ, 4BOH, 4BTI, 4BTT, 4BTU, 4CH2, 4CH8, 4DIH, 4DII, 4DT7, 4DY7, 4E05, 4E06, 4E7N, 4E7R, 4GSO, 4H6S, 4H6T, 4HFP, 4HTC, 4HZH, 4I7Y, 4LOY, 4LXB, 4LZ1, 4LZ4, 4MLF, 4P10, 4RKJ, 4RKO, 4RN6, 4THN, 4UD9, 4UDW, 4UE7, 4UEH, 4UFD, 4UFE, 4UFF, 4UFG, 4YES, 5A2M, 5AF9, 5AFY, 5AFZ, 5AHG, 5CMX, 5DO4, 5E8E, 5EW1, 5EW2, 5GDS, 5GIM, 5HVF, 5HVG, 5HVH, 5JDU, 5JFD, 5JQN, 5JZY, 5L6N, 5LCE, 5LPD, 5MJT, 5MLS, 5MM6, 5NDD, 5NDZ, 5NHU, 5NJ6, 5TO3, 5XRF, 6CYM, 6EO6, 6EO7, 6EO8, 6EO9, 6EVV, 6FJT, 6GBW, 6GN7, 6GWE, 6HSX, 6I51, 6P9U, 6PXJ, 6PXQ, 6ROT, 6T3M, 6T3Q, 6T4A, 6T52, 6T53, 6T54, 6T55, 6T56, 6T57, 6T7H, 6T89, 6T8A, 6TDT, 6TFI, 6TKG, 6TKH, 6TKI, 6TKJ, 6TKL, 6V64, 6Y02, 6Y9H, 6YB6, 6YHG, 6YHJ, 6YMP, 6YN3, 6YQV, 6YSJ, 6YSX, 6Z48, 6Z8V, 6Z8W, 6Z8X, 6ZGO, 6ZUG, 6ZUH, 6ZUN, 6ZUU, 6ZUW, 6ZUX, 6ZV7, 6ZV8, 7A0D, 7A0E, 7A0F, 7AC9, 7KME, 7MJ5, 7NEE, 7NEU, 7NTU, 7PHX, 7SR9, 7V3T, 7ZKL, 7ZKM, 7ZKN, 7ZKO, 8ASE, 8ASF, 8BW5, 8BWW, 8EF4, 8KME
CAS-ID	—
RxCUI	—
ChEMBL ID	CHEMBL2108110
ChEBI ID	—
PubChem CID	—
DrugBank	—
UNII ID	25ADE2236L (ChemIDplus, GSRS)