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tranexamic acid

Trade name: cyklokapron

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 30, 1986

Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin. Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. Tranexamic acid in a concentration of 1 mg per mL does not aggregate platelets in vitro. In patients with hereditary angioedema, inhibition of the formation and activity of plasmin by tranexamic acid may prevent attacks of angioedema by decreasing plasmin-induced activation of the first complement protein (C1). Tranexamic acid is used for use in patients with hemophilia for short term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. It can also be used for excessive bleeding in menstruation, surgery, or trauma cases. — NCATS

Clinical trial activity

662 trials · 508 clinical orgs · 42 marketing orgs

Phase 1
54
Phase 2
219
Phase 3
162
Phase 4
207

Earliest trial started Jan 1, 2001 (NCT00111215)

Timeline

1980s

  1. Dec 3, 1985

    Orphan Drug Designation

  2. Dec 30, 1986

    Pharmacia & Upjohn — Earliest FDA Approval

  3. Dec 30, 1986

    Pharmacia & Upjohn — NDA Secondary Org

  4. Dec 30, 1986

    Pfizer — Marketing Organization

  5. Dec 30, 1986

    Pharmacia & Upjohn — NDA Organization

  6. Dec 30, 1986

    Pfizer — NDA Secondary Org

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

  4. Nov 13, 2009

    Amring Pharmaceticals — Marketing Organization

  5. Nov 13, 2009

    Ferring — NDA Secondary Org

  6. Nov 13, 2009

    Amring Pharmaceticals — NDA Secondary Org

2010s

  1. Aug 10, 2011

    Lutipold — Marketing Organization

  2. Aug 10, 2011

    Sankyo — Marketing Organization

  3. Aug 10, 2011

    Daiichi Sankyo — Marketing Organization

  4. Nov 17, 2011

    Akorn, Inc. — Marketing Organization

  5. Nov 17, 2011

    Epic Pharma Llc — Marketing Organization

  6. Mar 2, 2012

    Fresenius — Marketing Organization

  7. Dec 27, 2012

    Actavis — Marketing Organization

  8. Jun 14, 2013

    X Gen Pharmaceuticals — Marketing Organization

  9. Jan 27, 2014

    Apotex — Marketing Organization

  10. Feb 11, 2014

    Acic Pharmaceuticals — Marketing Organization

  11. Feb 11, 2014

    Heritage Pharma — Marketing Organization

  12. Aug 12, 2014

    Emcure — Marketing Organization

  13. Aug 12, 2014

    Avet Lifesciences — Marketing Organization

  14. Sep 21, 2015

    Mylan — Marketing Organization

  15. Jan 14, 2016

    Aurobindo Pharma — Marketing Organization

  16. Jan 14, 2016

    Eugia Pharma — Marketing Organization

  17. Feb 25, 2016

    ANDA Repository — Marketing Organization

  18. Feb 25, 2016

    Virtus Pharms — Marketing Organization

  19. Feb 25, 2016

    Chartwell Pharmaceuticals — Marketing Organization

  20. Jun 9, 2016

    Rising Pharmaceuticals — Marketing Organization

  21. Jul 25, 2016

    Ani Pharmaceuticals — Marketing Organization

  22. Jul 25, 2016

    Amerigen Pharmaceuticals — Marketing Organization

  23. Feb 13, 2017

    Gland Pharma Ltd — Marketing Organization

  24. Feb 28, 2017

    Amneal Pharmaceuticals — Marketing Organization

  25. Jun 27, 2017

    Micro Labs Ltd India — Marketing Organization

  26. Jun 27, 2017

    Viva Healthcare — Marketing Organization

  27. Jul 17, 2017

    Zydus Discovery DMCC — Marketing Organization

  28. Apr 15, 2019

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  29. Apr 15, 2019

    Exela Pharma Sciences, LLC. — Marketing Organization

  30. Jul 17, 2019

    Apollo Pharmacy — Marketing Organization

  31. Jul 17, 2019

    Caplin Point Laboratories — Marketing Organization

  32. Jul 17, 2019

    Provepharm Sas — Marketing Organization

  33. Jul 17, 2019

    Apollo Hospitals, Chennai, India — Marketing Organization

  34. Jul 17, 2019

    Milla Pharms — Marketing Organization

2020s

  1. Apr 16, 2024

    Nexus Pharmaceuticals — Marketing Organization

  2. Jun 11, 2024

    Rubicon Research — Marketing Organization

  3. Jun 11, 2025

    Appco Pharma — Marketing Organization

  4. Aug 19, 2025

    Bionpharma Inc — Marketing Organization

  5. Jan 26, 2026

    I3 Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 30, 1986

Chemistry & pharmacology

Loading structure…

SMILES

NC[C@H]1CC[C@@H](CC1)C(O)=O
Mol. weight
157.2102 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • acide tranexamique
  • acide tranexamique
  • acido tranexamico
  • acido tranexamico
  • acidum tranexamicum
  • acidum tranexamicum
  • amchafibrin
  • amikapron
  • cl-65336
  • cl-65336
  • cyclocapron
  • cyclokapron
  • cyclokapron
  • cyklo-f heavy period relief
  • cyklokapron
  • cyklokapron
  • exacyl
  • exacyl
  • exacyl
  • hexakaprone
  • lb1148
  • lysteda
  • lysteda
  • menstralite
  • ranelic acid
  • ranelic acid
  • traexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexamic acid
  • tranexaminic acid
  • tranexamsaeure
  • tranexamsaeure
  • tranexmic acid
  • tranexmic acid
  • tranhexamic acid
  • tranhexamic acid
  • tranol
  • trans-4-aminomethylcyclohexane-1-carboxylic acid
  • trans-4-aminomethylcyclohexane-1-carboxylic acid
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
  • trans amcha
  • trans amcha
  • trans amcha
  • trans-amcha
  • trans-amcha
  • transamin
  • trans-tranexamic acid
  • trans-tranexamic acid
  • zataranax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06894719Phase 4Jan 1, 2026Rush University
NCT07116395Phase 4Jan 1, 2026University of California, San Francisco
NCT06902714Phase 3Dec 15, 2025University of Alabama, Birmingham
NCT07245264Phase 2/Phase 3 (Phase 3)Dec 10, 2025Norwegian University of Science and Technology, Postgraduate Institute of Medical Education and Research
NCT07131592Phase 4Nov 1, 2025Harvard University
NCT07115056Phase 4Nov 1, 2025Campbell Clinic, Duke University, Endeavor Health, University of Cincinnati, University of Pittsburgh, Washington University in St. Louis
NCT07192640N/AOct 15, 2025Ain Shams University
NCT06519422Phase 3Sep 30, 2025JP Moulton Charitable Foundation, University of London
NCT07157631N/ASep 29, 2025Anhui Medical University, Fudan University, Fujian Medical University, Guangxi Medical University, Guangzhou Medical University, Hacettepe University, Hebei University, Huazhong University of Science and Technology, Jiao Tong University, Jinlin University, Nanjing Medical University, Nanjing University, Qingdao University, Shandong first medical University, Sichuan University, Sun Yat-Sen University, Tianjin Medical University, University of Science and Technology of China, Zhejiang University, Zhengzhou University
NCT07127042Phase 2Sep 1, 2025ScinnoHub Pharmaceutical Co., Ltd.
NCT07212452Phase 2/Phase 3 (Phase 3)Aug 1, 2025University of Health Sciences Lahore
NCT07078942Phase 4Jul 20, 2025Chulalongkorn University
NCT07089251Phase 4Jul 15, 2025King Abdullah Medical City
NCT07169383Phase 2Jun 28, 2025PAEC General Hospital, Islamabad
NCT07263841Phase 2Jun 1, 2025King Edward Medical University
NCT07195539N/AJun 1, 2025King Edward Medical University
NCT07002749Phase 1Jun 1, 2025Patel Hospital Pvt. Ltd.
NCT06997796Phase 1/Phase 2 (Phase 2)May 31, 2025Peterborough Regional Health Centre, University of Ottawa
NCT06983886Phase 1/Phase 2 (Phase 2)May 12, 2025Mahidol University
NCT06820177Phase 4Mar 31, 2025University of California, San Diego
Showing 20 of 662 trials
Page 1 / 34

Organizations

Research & Development (508)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cairo UniversityAcademic/Hospital252452018
Aswan UniversityAcademic/Hospital212022018
Assiut UniversityAcademic/Hospital202052009
University of TorontoAcademic/Hospital161432003
Ain Shams UniversityAcademic/Hospital141352010
Chinese Academy of Medical SciencesAcademic/Hospital111022008
University of LondonAcademic/Hospital111132005
McMaster UniversityAcademic/Hospital8722015
Chang Gung UniversityAcademic/Hospital7712012
Jiao Tong UniversityAcademic/Hospital7632014
New York UniversityAcademic/Hospital7722008
Norwegian University of Science and TechnologyAcademic/Hospital7742006
Rush UniversityAcademic/Hospital7742012
University of PittsburghAcademic/Hospital7632008
Harvard UniversityAcademic/Hospital6622012
Mayo ClinicAcademic/Hospital6532004
Northwestern UniversityAcademic/Hospital6642013
People's Liberation Army of ChinaGovernment6422013
Rockefeller UniversityAcademic/Hospital6632013
Seoul National UniversityAcademic/Hospital6642011
508 organizations
Page 1 / 26

Marketing (55)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGFeb 25, 2016
Acic PharmaceuticalsFor profitMKTGFeb 11, 2014
ActavisFor profitMKTGDec 27, 2012
Akorn, Inc.For profitMKTGNov 17, 2011
Amerigen PharmaceuticalsFor profitMKTGJul 25, 2016
Amneal PharmaceuticalsFor profitMKTGFeb 28, 2017
Amneal PharmaceuticalsFor profitSYNOct 16, 2023
Amring PharmaceticalsFor profitMKTGNov 13, 2009
Amring PharmaceticalsFor profitNDA2Nov 13, 2009
Ani PharmaceuticalsFor profitMKTGJul 25, 2016
Ani PharmaceuticalsFor profitMKTGJul 25, 2016
Apollo Hospitals, Chennai, IndiaAcademic/HospitalMKTGJul 17, 2019
Apollo PharmacyAcademic/HospitalMKTGJul 17, 2019
ApotexFor profitMKTGJan 27, 2014
ApotexFor profitSYNJan 14, 2020
Appco PharmaFor profitMKTGJun 11, 2025
Aurobindo PharmaFor profitSYNSep 21, 2015
Aurobindo PharmaFor profitMKTGJan 14, 2016
Avet LifesciencesFor profitMKTGAug 12, 2014
Bionpharma IncFor profitMKTGAug 19, 2025
Caplin Point LaboratoriesFor profitMKTGJul 17, 2019
Chartwell PharmaceuticalsFor profitMKTGFeb 25, 2016
Daiichi SankyoFor profitMKTGAug 10, 2011
EmcureFor profitMKTGAug 12, 2014
Epic Pharma LlcFor profitMKTGNov 17, 2011
Eugia PharmaFor profitMKTGJan 14, 2016
Exela Pharma Sciences, LLC.For profitNDA2Apr 15, 2019
Exela Pharma Sciences, LLC.For profitMKTGApr 15, 2019
FerringFor profitNDA2Nov 13, 2009
FreseniusFor profitMKTGMar 2, 2012
Gland Pharma LtdFor profitMKTGFeb 13, 2017
Gland Pharma LtdFor profitMKTGFeb 13, 2017
Heritage PharmaFor profitMKTGFeb 11, 2014
I3 PharmsFor profitMKTGJan 26, 2026
LutipoldFor profitMKTGAug 10, 2011
Micro Labs Ltd IndiaFor profitMKTGJun 27, 2017
Milla PharmsFor profitMKTGJul 17, 2019
MylanFor profitMKTGSep 21, 2015
MylanFor profitSYNNov 3, 2011
MylanFor profitSYNSep 21, 2015
Nexus PharmaceuticalsFor profitMKTGApr 16, 2024
PfizerFor profitMKTGDec 30, 1986
PfizerFor profitNDA2Dec 30, 1986
Pharmacia & UpjohnFor profitNDA2Dec 30, 1986
Pharmacia & UpjohnFor profitNDADec 30, 1986
Provepharm SasFor profitMKTGJul 17, 2019
Rising PharmaceuticalsFor profitMKTGJun 9, 2016
Rubicon ResearchFor profitMKTGJun 11, 2024
Rubicon ResearchFor profitSYNJun 11, 2024
SankyoFor profitMKTGAug 10, 2011
Virtus PharmsFor profitMKTGFeb 25, 2016
Viva HealthcareFor profitMKTGJun 27, 2017
X Gen PharmaceuticalsFor profitSYNJun 14, 2013
X Gen PharmaceuticalsFor profitMKTGJun 14, 2013
Zydus Discovery DMCCFor profitMKTGJul 17, 2017