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Drug ReportsTranexamic acid
Tranexamic acid
Cyklokapron, Lysteda, Tranexamic Acid (tranexamic acid) is a small molecule pharmaceutical. Tranexamic acid was first approved as Cyklokapron on 1986-12-30. It is used to treat inherited blood coagulation disorders and subarachnoid hemorrhage in the USA. The pharmaceutical is active against plasminogen.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cyklokapron, Lysteda, Tranexamic acid (discontinued: Cyklokapron, Tranexamic acid)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tranexamic acid
Tradename
Company
Number
Date
Products
LYSTEDAAmring PharmaceuticalsN-022430 RX2009-11-13
1 products, RLD, RS
TRANEXAMIC ACIDExela Pharma SciencesN-212020 RX2019-04-15
1 products, RLD, RS
CYKLOKAPRONPfizerN-019281 RX1986-12-30
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cyklokapronNew Drug Application2025-01-30
pure whitenol serumunapproved drug other2015-03-06
rosacea therapyC2002632023-12-29
skinmd laboratories pure whitenol intensiveunapproved drug other2019-12-24
skinmd laboratories pure whitenol serumunapproved drug other2019-12-24
skinmd laboratories revitox blueunapproved drug other2018-11-28
tranexamic acidANDA2025-03-01
tranexamic acid in sodium chlorideANDA2025-01-14
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
TRANEXAMIC ACID, TRANEXAMIC ACID, AMNEAL
2024-04-16CGT
Patent Expiration
Patent
Expires
Flag
FDA Information
Tranexamic Acid, Lysteda, Amring Pharms
79477392025-03-04DP
80221062025-03-04U-1182
82737952025-03-04U-1182
84870052025-03-04DPU-1182
87911602025-03-04DPU-1182
88093942025-03-04DPU-1182
89571132025-03-04DPU-1182
90609392025-03-04DP
ATC Codes
B: Blood and blood forming organ drugs
— B02: Antihemorrhagics
— B02A: Antifibrinolytics
— B02AA: Antifibrinolytic amino acids
— B02AA02: Tranexamic acid
HCPCS
No data
Clinical
Clinical Trials
870 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R58———2—2
ColectomyD003082—————1—1
GastrectomyD005743—————1—1
PancreaticoduodenectomyD016577—————1—1
EsophagectomyD016629—————1—1
Biliary tract surgical proceduresD001662—————1—1
Bone fracturesD050723EFO_0003931T14.8———1—1
Femoral fracturesD005264—S72———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25—11——1
Hepatocellular carcinomaD006528—C22.0—11——1
Stomach neoplasmsD013274EFO_0003897C16—11——1
Liver neoplasmsD008113EFO_1001513C22.0—11——1
Colonic neoplasmsD003110—C18—11——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTranexamic acid
INNtranexamic acid
Description
Tranexamic acid is a monocarboxylic acid. It has a role as an antifibrinolytic drug and a hematologic agent. It is functionally related to a cyclohexanecarboxylic acid.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
NC[C@H]1CC[C@H](C(=O)O)CC1
Identifiers
PDB—
CAS-ID1197-18-8
RxCUI—
ChEMBL IDCHEMBL877
ChEBI ID48669
PubChem CID5526
DrugBankDB00302
UNII ID6T84R30KC1 (ChemIDplus, GSRS)
Target
Agency Approved
PLG
PLG
Organism
Homo sapiens
Gene name
PLG
Gene synonyms
NCBI Gene ID
Protein name
plasminogen
Protein synonyms
plasmin
Uniprot ID
Mouse ortholog
Plg (18815)
plasminogen (Q91WJ5)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Tranexamic acid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,482 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,640 adverse events reported
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