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
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 |
|---|---|---|---|---|
| LYSTEDA | Amring Pharmaceuticals | N-022430 RX | 2009-11-13 | 1 products, RLD, RS |
| TRANEXAMIC ACID | Exela Pharma Sciences | N-212020 RX | 2019-04-15 | 1 products, RLD, RS |
| CYKLOKAPRON | Pfizer | N-019281 RX | 1986-12-30 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cyklokapron | New Drug Application | 2024-04-03 |
| lysteda | New Drug Application | 2021-12-02 |
| pure whitenol serum | unapproved drug other | 2015-03-06 |
| rosacea therapy | C200263 | 2023-12-29 |
| skinmd laboratories pure whitenol intensive | unapproved drug other | 2019-12-24 |
| skinmd laboratories pure whitenol serum | unapproved drug other | 2019-12-24 |
| skinmd laboratories revitox blue | unapproved drug other | 2018-11-28 |
| tranexamic acid | ANDA | 2024-10-28 |
| tranexamic acid in sodium chloride | ANDA | 2024-04-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| subarachnoid hemorrhage | EFO_0000713 | D013345 | I60 |
| inherited blood coagulation disorders | — | D025861 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TRANEXAMIC ACID, TRANEXAMIC ACID, AMNEAL | |||
| 2024-04-16 | CGT | ||
HCPCS
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Clinical
Clinical Trials
841 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 | 22 | 47 | 72 | 83 | 86 | 292 |
| Surgical blood loss | D016063 | — | — | 5 | 8 | 18 | 17 | 12 | 56 |
| Postpartum hemorrhage | D006473 | — | O72 | 5 | 12 | 18 | 10 | 17 | 56 |
| Postoperative hemorrhage | D019106 | — | — | 4 | 6 | 10 | 10 | 10 | 38 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | 2 | 2 | 7 | 13 | 10 | 34 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 4 | 2 | 10 | 14 | 30 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 5 | 5 | 6 | 13 | 29 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | 1 | 3 | 7 | 9 | 7 | 26 |
| Melanosis | D008548 | HP_0001480 | L81.1 | 4 | 3 | 5 | 3 | 10 | 23 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | 2 | 1 | 6 | 6 | 6 | 20 |
Show 149 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 23 | 42 | 16 | — | 1 | 73 |
| Lymphoma | D008223 | — | C85.9 | 29 | 48 | 11 | — | — | 73 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 16 | 33 | 15 | — | — | 58 |
| Lymphoid leukemia | D007945 | — | C91 | 18 | 32 | 15 | — | — | 58 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 16 | 27 | 3 | — | — | 36 |
| Recurrence | D012008 | — | — | 19 | 23 | 1 | — | — | 34 |
| B-cell lymphoma | D016393 | — | — | 18 | 19 | 3 | — | — | 32 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 17 | 16 | 2 | — | — | 26 |
| Hodgkin disease | D006689 | — | C81 | 6 | 14 | 3 | — | — | 19 |
| Syndrome | D013577 | — | — | 6 | 10 | 1 | — | 2 | 18 |
Show 79 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 10 | 16 | — | — | 1 | 23 |
| Myeloid leukemia | D007951 | — | C92 | 10 | 16 | — | — | 1 | 23 |
| Myelodysplastic syndromes | D009190 | — | D46 | 8 | 15 | — | — | 1 | 21 |
| Multiple myeloma | D009101 | — | C90.0 | 10 | 12 | — | — | — | 19 |
| Preleukemia | D011289 | — | — | 6 | 10 | — | — | 1 | 16 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 4 | 13 | — | — | — | 15 |
| Plasma cell neoplasms | D054219 | — | — | 9 | 7 | — | — | — | 14 |
| Mantle-cell lymphoma | D020522 | — | — | 6 | 10 | — | — | — | 13 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 3 | 9 | — | — | — | 11 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 4 | 7 | — | — | — | 9 |
Show 92 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee prosthesis | D007720 | — | — | 1 | — | — | — | 1 | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | — | — | — | — | 2 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 1 | — | — | — | — | 1 |
| Hemoglobinopathies | D006453 | — | D58.2 | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | — | 1 | — | — | — | — | 1 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrinolysis | D005342 | — | — | — | — | — | — | 7 | 7 |
| Hemostasis | D006487 | — | — | — | — | — | — | 3 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 2 | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 2 | 2 |
| Hypokalemia | D007008 | HP_0002900 | E87.6 | — | — | — | — | 2 | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 2 | 2 |
Show 118 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tranexamic acid |
| INN | tranexamic 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC[C@H]1CC[C@H](C(=O)O)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1197-18-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL877 |
| ChEBI ID | 48669 |
| PubChem CID | 5526 |
| DrugBank | DB00302 |
| UNII ID | 6T84R30KC1 (ChemIDplus, GSRS) |
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Tranexamic acid
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Safety
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3,281 adverse events reported
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