Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). Sold as Cyklokapron, Lysteda, Tranexamic Acid. Every FDA application for this active ingredient: 4 branded and 32 generic.

As of Nov 14, 2026, FDA lists 36 applications for Tranexamic Acid (sold as Cyklokapron, Lysteda, Tranexamic Acid), first approved Dec 30, 1986, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 30, 1986
Applications: 36
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Tranexamic Acid	Part D	$3.9M	+31%	84,028

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TRANEXAMIC ACID 1,000 MG/10 ML: $0.397 per MLGeneric · +14% in a year
TRANEXAMIC ACID 650 MG TABLET: $0.829 per unitGeneric · -18% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

For use in patients with congenital coagulopathies undergoing surgical procedures, e.g. dental extractionsPharmacia Inc. · designated Dec 3, 1985 · approved Dec 30, 1986

Clinical Trials

153 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative StudyMelasma (Facial Melasma) · Bangladesh Medical University	Phase 4	Active, not recruiting	Oct 23, 2026
New Treatment in MelasmaFemale, With · Sohag University	Not applicable	Not yet recruiting	Oct 21, 2026
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL ReconstructionAnterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture · Dave Bernholt	Phase 3	Not yet recruiting	Oct 19, 2026
Baseline Dermoscopic Vascular Score and Response to Oral Tranexamic Acid in Facial MelasmaMelasma · Allied Hospital Faisalabad	Phase 4	Not yet recruiting	Oct 19, 2026
The Safety of Simplified Tranexamic Acid RegimenTrauma Coagulopathy, Hemorrhage · Second Affiliated Hospital, Zhejiang University, School of Medicine	Phase 4	Recruiting	Oct 9, 2026
Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee ArthroplastyKnee Osteoarthritis · The Second Affiliated Hospital of Kunming Medical University	Phase 4	Not yet recruiting	Oct 2, 2026
Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for HemoptysisHemoptysis · Dow University of Health Sciences	Phase 4	Enrolling by invitation	Sep 29, 2026
Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical HerniaUmbilical Hernia Repair · Dr Mudassar Saeed Pansota	Not applicable	Not yet recruiting	Sep 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 30, 1986	CyklokapronNDA 19280 · New molecular entity	Pharmacia And Upjohn	1	Discontinued
Dec 30, 1986	CyklokapronNDA 19281 · New dosage form	Pfizer	33	Marketed
Nov 13, 2009	LystedaNDA 22430 · New dosage form	J Molner	6	Marketed
Aug 10, 2011	Tranexamic AcidANDA 201885	Am Regent	5	Discontinued
Nov 3, 2011	Tranexamic AcidANDA 91657	Mylan Institutional	4	Marketed
Nov 17, 2011	Tranexamic AcidANDA 202373	Epic Pharma LLC	2	Marketed
Mar 2, 2012	Tranexamic AcidANDA 91596	Fresenius Kabi USA	3	Discontinued
Dec 27, 2012	Tranexamic AcidANDA 202093	Actavis Labs Fl Inc	2	Marketed
Jun 14, 2013	Tranexamic AcidANDA 201580	Pharmobedient	4	Marketed
Jan 27, 2014	Tranexamic AcidANDA 202286	Apotex	1	Discontinued
Feb 11, 2014	Tranexamic AcidANDA 202436	Heritage	5	Marketed
Aug 12, 2014	Tranexamic AcidANDA 203521	Avet Lifesciences	4	Marketed
Sep 21, 2015	Tranexamic AcidANDA 205133	Aurobindo Pharma USA	1	Marketed
Jan 14, 2016	Tranexamic AcidANDA 205035	Eugia Pharma	4	Marketed
Feb 25, 2016	Tranexamic AcidANDA 202755	Chartwell Rx	3	Discontinued
Jun 9, 2016	Tranexamic AcidANDA 206634	Rising	2	Discontinued
Jul 25, 2016	Tranexamic AcidANDA 203256	Ani Pharms	1	Marketed
Feb 13, 2017	Tranexamic AcidANDA 207239	Gland	1	Marketed
Feb 28, 2017	Tranexamic AcidANDA 208840	Amneal Pharms Co	3	Marketed
Jun 27, 2017	Tranexamic AcidANDA 206713	Micro Labs	5	Marketed
Jul 17, 2017	Tranexamic AcidANDA 205228	Zydus Pharms	3	Discontinued
Sep 28, 2017	Tranexamic AcidANDA 206594	Epic Pharma LLC	2	Discontinued
Apr 15, 2019	Tranexamic AcidNDA 212020 · New formulation or manufacturer	Exela Pharma	1	Marketed
Jul 17, 2019	Tranexamic AcidANDA 212360	Caplin	2	Marketed
Jul 17, 2019	Tranexamic AcidANDA 212676	Milla Pharms	2	Marketed
Jan 14, 2020	Tranexamic AcidANDA 209860	Apotex	2	Marketed
Oct 16, 2023	Tranexamic AcidANDA 217155	Amneal	2	Marketed
Apr 16, 2024	Tranexamic AcidANDA 216877	Nexus	0	Marketed
Apr 16, 2024	Tranexamic AcidANDA 218599	Gland	0	Marketed
Jun 11, 2024	Tranexamic AcidANDA 218320	Rubicon Research	0	Marketed
Aug 15, 2024	Tranexamic AcidANDA 218242	Fresenius Kabi USA	0	Marketed
Jun 2, 2025	Tranexamic AcidANDA 218896	Heritage	0	Marketed
Jun 11, 2025	Tranexamic AcidANDA 218729	Appco	0	Marketed
Aug 19, 2025	Tranexamic AcidANDA 219123	Bionpharma	0	Discontinued
Jan 26, 2026	Tranexamic AcidANDA 219702	Pharmazone	0	Marketed
Oct 27, 2026	Tranexamic AcidANDA 221213	Zydus Lifesciences	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA